Medical Device Regulation

Article 1 Subject matter and scope

This regulation establishes rules for placing on the market, making available, or putting into service medical devices and accessories for human use in the Union, and for clinical investigations of such devices, including products in Annex XVI without an intended medical purpose (with common specifications effective six months after entry into force or 26 May 2020, whichever is later). It excludes animal transplants and viable biological material, food, and products containing viable organisms, but covers devices made from non-viable animal tissues or cells and non-viable human tissues or cells (unless they have viable human tissue). Devices administering medicinal products are governed by this regulation unless marketed as a single non-reusable integral product exclusively for use together (in which case medicinal product rules apply with device safety requirements in Annex I), and devices with non-viable human tissues or cells follow this regulation plus tissue and cell donation and testing requirements, while products where tissues or cells have principal action follow tissue and cell rules with device safety requirements applied to the device part.

Article 2 Definitions

Article 2 defines 'medical device' as an instrument, apparatus, software, implant, reagent or material for human diagnosis, prevention, monitoring, treatment, alleviation or investigation, excluding products functioning through pharmacological, immunological or metabolic means as principal action, and 'accessory' as an article enabling or assisting a device's use without being itself a device. It establishes definitions for device categories (invasive, generic groups, single-use, falsified, procedure packs, systems), manufacturer specifications (intended purpose, labels, instructions for use, unique identifiers), nanomaterials, performance, risk, benefit-risk determination, compatibility, interoperability, market activities (making available, placing, putting into service), and economic operators (manufacturers, representatives, importers, distributors, users). It defines conformity assessment, CE marking, clinical evaluation and investigation, clinical data and evidence, clinical benefit and performance, adverse and serious adverse events, device deficiencies, post-market surveillance, market surveillance, recalls, withdrawals, incidents, serious incidents, serious public health threats, and related procedures.

Article 3 Amendment of certain definitions

Grants the Commission power to adopt delegated acts to amend the definitions of nanomaterial and related terms in light of technical and scientific progress, considering Union and international level definitions.

Article 4 Regulatory status of products

The Commission must determine upon substantiated request from a Member State whether a product qualifies as a medical device or accessory, after consulting the Medical Device Coordination Group. The Commission may also decide this independently. Member States must share expertise across multiple product areas to determine appropriate regulatory status, and the Commission must consult relevant EU agencies when products involve medicinal items, tissues, cells, or food.

Article 5 Placing on the market and putting into service

Devices may be distributed only if compliant with this Regulation when properly supplied, installed, maintained and used as intended, and must meet general safety and performance requirements with clinical evaluation. Health institutions may manufacture and use devices without meeting most Regulation requirements if they meet specific conditions including documentation, quality management, public declaration, competent authority access, and corrective action; this exception does not apply to industrial-scale manufacturing.

Article 6 Distance sales

Devices offered by information society services to persons in the Union must comply with the regulation. Devices used in commercial activities for diagnostic or therapeutic services through information society services or other means must also comply. Persons offering such devices must provide copies of conformity declarations upon request.

Article 7 Claims

Labelling, instructions, marketing and advertising must not use misleading text, names, marks or signs that misrepresent the device's intended purpose, safety or performance by ascribing false functions, creating false impressions about treatment or diagnosis, failing to inform of risks, or suggesting uses outside the stated intended purpose.

Article 8 Use of harmonised standards

Devices conforming to published harmonised standards are presumed to comply with covered requirements. This presumption applies to system or process requirements including quality management, risk management, post-market surveillance, clinical investigations and evaluation. European Pharmacopoeia monographs on surgical sutures and medicinal product interactions published with references are treated as harmonised standards.

Article 9 Common specifications

When harmonised standards are absent, insufficient, or public health concerns exist, the Commission may adopt common specifications addressing general safety and performance requirements, technical documentation, clinical evaluation, post-market follow-up, and clinical investigation requirements. Devices meeting these specifications are presumed compliant, though manufacturers may use equivalent alternatives with proper justification, except for products in Annex XVI which must comply.

Article 10 General obligations of manufacturers

Manufacturers must ensure compliance with all Regulation requirements, establish risk management and quality management systems covering regulatory compliance, supplier control, clinical evaluation, product development, UDI verification, post-market surveillance, incident reporting, and corrective actions; maintain technical documentation for 10 years (15 years for implantable devices) after last device placement; conduct clinical evaluations with post-market follow-up; draw up EU declarations of conformity and affix CE marks; comply with UDI and registration obligations; maintain production conformity as standards change; ensure indelible, legible labelling in required Union language(s); and immediately take corrective action, withdraw or recall non-compliant devices, notifying distributors and authorities where serious risks exist. Manufacturers must maintain post-market surveillance and incident reporting systems, provide requested documentation to competent authorities, submit identity information for other persons designing or manufacturing devices, and establish financial coverage proportionate to device risk class, type, and enterprise size for potential liability under Directive 85/374/EEC.

Article 11 Authorised representative

Manufacturers not established in a Member State must designate a single written-accepted authorised representative for all devices in the same generic device group to place devices on the Union market; the representative must verify conformity documentation and procedures, maintain technical documentation and certificates, comply with registration obligations, provide conformity information to competent authorities, facilitate access to samples and devices, cooperate on corrective actions, and report incidents and complaints, but cannot assume manufacturer obligations regarding design, manufacturing, conformity assessment, CE marking, UDI registration or corrective action. Representatives terminating a mandate due to manufacturer non-compliance must immediately notify the competent authority of their Member State and any involved notified body with the reasons for termination. References to the manufacturer's competent authority apply instead to the competent authority where the representative is established.

Article 12 Change of authorised representative

An agreement between the manufacturer and the outgoing and incoming authorised representatives must define when mandates begin and end, how long the former representative may appear in manufacturer materials, how documents and property rights transfer, and the former representative's duty to forward complaints and incident reports after their mandate ends.

Article 13 General obligations of importers

Importers must place only compliant devices on the market, verify CE marking, proper declarations of conformity, manufacturer and authorised representative identification, labelling, instructions and unique device identifiers, and must withhold non-compliant or falsified devices and notify manufacturers, representatives and competent authorities. Importers must display their contact details and registered location on or with devices without obscuring manufacturer labels, ensure registration in the electronic system, maintain proper storage and transport, keep complaint and recall registers, immediately forward complaints and incident reports to the manufacturer and authorised representative, retain EU declarations of conformity and certificates for the period in Article 10(8), and cooperate with manufacturers and competent authorities on corrective actions and risk elimination by providing device samples free of charge or granting access when requested.

Article 14 General obligations of distributors

Distributors must exercise due care regarding applicable requirements when making devices available on the market, verify before doing so that devices are CE marked with proper conformity declarations and accompanying manufacturer-supplied information, that importers have complied with identification requirements, and that unique device identifiers have been assigned where applicable (using sampling methods if needed). If non-compliance is suspected, distributors must withhold the device and inform the manufacturer, authorised representative and importer; for serious risk or falsified devices, they must also inform competent authorities. Distributors must maintain manufacturer-specified storage and transport conditions, immediately inform the manufacturer, authorised representative and importer of any placed non-compliant device, cooperate on corrective actions, and inform competent authorities of Member States where non-compliant devices were made available if serious risk is suspected.

Article 15 Person responsible for regulatory compliance

Manufacturers must have at least one person with requisite expertise in regulatory compliance, qualified either by university degree or equivalent in law, medicine, pharmacy, engineering or relevant discipline plus one year of regulatory or quality management experience in medical devices, or by four years of such professional experience; custom-made device manufacturers need only two years of relevant manufacturing experience. Micro and small enterprises need not employ such a person internally but must have one continuously available. This person is responsible for ensuring device conformity checks, maintaining technical documentation and conformity declarations, complying with post-market surveillance, fulfilling reporting obligations, and issuing statements for investigational devices.

Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons

A distributor, importer or other person assumes manufacturer obligations if it markets a device under its own name or trade mark (unless a manufacturer is identified in writing), changes the device's intended purpose, or modifies it in ways affecting compliance, but excluding those who merely assemble or adapt devices for individual patients without changing purpose or who only translate information or repackage with size changes provided repackaging preserves condition and sterile packaging. When relabelling or repackaging, such entities must indicate this activity with their name, business address and contact details on the device, package or accompanying document; maintain a quality management system ensuring translation accuracy and proper handling; receive manufacturer notifications of corrective actions; and inform the manufacturer and national competent authority at least 28 days before making the device available, providing samples if requested and a notified body certificate confirming their quality management system meets required standards.

Article 17 Single-use devices and their reprocessing

Single-use devices may only be reprocessed where permitted by national law; a reprocessor becomes the manufacturer and assumes all obligations including traceability, though Member States may exempt health institutions if the reprocessed device's safety and performance match the original and it meets requirements on risk management, validation, testing, quality management, incident reporting and traceability. Only devices placed on the market under this Regulation or before 26 May 2020 under the previous directive may be reprocessed if current scientific evidence considers this safe; reprocessing must follow technical standards adopted by 26 May 2020, or if not adopted, relevant harmonised standards and national provisions certified by a notified body. The reprocessed device label must bear the reprocessor's name and address; the original manufacturer's name may not appear on the label but must be in the instructions for use.

Article 18 Implant card and information to be supplied to the patient with an implanted device

Article 19 EU declaration of conformity

The manufacturer must draw up and continuously update an EU declaration of conformity stating that the device meets all requirements laid down in this Regulation, containing minimum information specified in Annex IV, and translated into required official Union language(s). Where a device is subject to other Union legislation also requiring an EU declaration of conformity, a single combined declaration may be drawn up covering all applicable Union acts. By drawing up the declaration, the manufacturer assumes responsibility for compliance with this Regulation and all other applicable Union legislation.

Article 20 CE marking of conformity

Compliant devices, except custom-made and investigational ones, must display the CE mark as specified in Annex V. The mark must be visibly, legibly and durably affixed to the device or sterile packaging, or to the packaging alone if the device makes this impracticable, and must also appear in instructions and sales packaging. Where a notified body conducts conformity assessment, its identification number must follow the mark.

Article 21 Devices for special purposes

Member States must allow investigational devices to be supplied to investigators and custom-made devices to be made available if specified conditions are met, without the CE mark except in certain cases. Custom-made devices must carry a statement in Annex XIII and be identified to a specific patient or user. Member States may require manufacturers to submit lists of custom-made devices made available in their territory.

Article 22 Systems and procedure packs

When combining CE-marked devices with other compliant devices or products for compatible use as a system or procedure pack, the combiner must declare that the devices are mutually compatible, properly packaged with relevant user information, and subject to appropriate monitoring and verification. For sterilisation, the combiner may apply procedures in Annex IX or Part A of Annex XI, limited to sterility assurance and must declare compliance with manufacturer instructions. If devices lack the CE mark or are incompatible, or sterilisation is non-compliant, the system or procedure pack is treated as a new device requiring full conformity assessment and assumes manufacturer obligations.

Article 23 Parts and components

Anyone making available a replacement part or component for a defective or worn integral part of a device must ensure it does not adversely affect the device's safety and performance, keeping supporting evidence available for competent authorities. A replacement part that significantly changes the device's performance, safety characteristics or intended purpose is itself classified as a device subject to all regulatory requirements.

Article 24 Free movement

Member States must not refuse, prohibit or restrict the supply or putting into service of devices that comply with this Regulation.

Article 25 Identification within the supply chain

Distributors and importers must cooperate with manufacturers or authorised representatives to achieve appropriate traceability. Economic operators must be able to identify to competent authorities their direct suppliers of devices and their direct recipients, as well as health institutions and healthcare professionals to which they have directly supplied devices, for the period specified in Article 10(8).

Article 26 Medical devices nomenclature

The Commission shall make an internationally recognised medical device nomenclature available free of charge to manufacturers and others required to use it by this Regulation, and shall endeavour to make it available free to other stakeholders where reasonably practicable, to support the European database on medical devices.

Article 27 Unique Device Identification system

The UDI system enables identification and traceability of non-custom and non-investigational devices through device and production identifiers, placed on labels and packaging, with recordkeeping by economic operators and health professionals and an electronic database. The Commission designates one or more issuing entities meeting criteria including legal personality, adequate assignment systems compliant with international standards, transparent access, and commitment to operate for at least 10 years. Manufacturers must assign UDIs before market placement, include the Basic UDI-DI on conformity declarations, ensure correct device information transfer to the database, and maintain up-to-date UDI records.

Article 28 UDI database

The Commission shall establish and operate a public UDI database designed to exclude UDI product identifiers and confidential product information, with core data elements provided free of charge. The database must ensure maximum accessibility through multi-user access and automatic data uploads and downloads, with the Commission providing technical and administrative support.

Article 29 Registration of devices

Manufacturers must assign a Basic UDI-DI to devices and system or procedure packs before market placement and register them with core data elements in the UDI database. For devices requiring notified body assessment, the Basic UDI-DI must be assigned before the notified body application; the body then confirms the reference data accuracy in Eudamed before the manufacturer provides registration information. Manufacturers must also enter or verify device information in Eudamed before market placement and keep it updated.

Article 30 Electronic system for registration of economic operators

Article 31 Registration of manufacturers, authorised representatives and importers

Before market placement, manufacturers, authorised representatives, and importers must submit required information to the electronic system; those requiring notified body assessment must do so before the body application. The competent authority verifies the data and issues a single registration number (SRN), which the manufacturer must use for notified body applications and Eudamed access. Operators must update their data within one week of changes and confirm accuracy annually (with six-month grace period for correction), during which any Member State may take corrective action if not complied with.

Article 32 Summary of safety and clinical performance

Manufacturers of implantable and class III non-custom non-investigational devices must prepare a clear summary of safety and clinical performance. The notified body validates the draft and uploads the validated summary to Eudamed; the manufacturer must reference its location on the device label or instructions. The summary must identify the device and manufacturer (with Basic UDI-DI and SRN if issued), state intended purpose and contraindications, describe the device and variants, list alternatives, reference applicable standards, summarise clinical evaluation data and post-market follow-up, specify user training needs, and detail residual risks and undesirable effects.

Article 33 European database on medical devices

Eudamed stores personal data only as needed for the information systems to work under this regulation and keeps it no longer than specified in Article 10(8). The Commission and Member States must ensure data subjects can exercise rights to information, access, correction and objection under the referenced data protection rules, including the right to request corrections and deletions which must occur within 60 days of the request.

Article 34 Functionality of Eudamed

Article 35 Authorities responsible for notified bodies

Each Member State intending to designate notified bodies must appoint an authority responsible for setting up assessment, designation, notification and monitoring procedures. This authority must be structured to protect objectivity and impartiality, separate decision-making from assessment, avoid commercial conflicts with notified bodies, safeguard confidential information while exchanging details with other authorities, maintain sufficient competent staff, and participate in peer review activities.

Article 36 Requirements relating to notified bodies

Article 37 Subsidiaries and subcontracting

When notified bodies subcontract or use subsidiaries for conformity assessment tasks, they must verify compliance with Annex VII requirements and inform the responsible authority, while taking full responsibility for the work. They must publicly list their subsidiaries, inform applicants of subcontracting, and keep all qualification and work documents available to the responsible authority.

Article 38 Application by conformity assessment bodies for designation

Conformity assessment bodies apply for designation specifying conformity assessment activities and device types, supported by documentation demonstrating compliance with requirements. Valid accreditation certificates and evaluation reports from national accreditation bodies may be submitted and considered during assessment, though all documentation must be available upon request. Notified bodies must update documentation whenever relevant changes occur to enable continuous compliance monitoring.

Article 39 Assessment of the application

The authority responsible for notified bodies has 30 days to check application completeness and request missing information, then forwards the complete application to the Commission, which transmits it to the MDCG and within 14 days appoints a joint assessment team of three experts (or different number if circumstances require) comprising one Commission representative and two from other Member States. Within 90 days the team reviews documentation, conducts an on-site assessment, discusses non-compliances with the responsible authority, after which the authority lists non-compliances and the applicant must submit a corrective and preventive action plan. The joint assessment team records any differing views within 30 days of finishing the on-site review and tells the competent authority; after receiving the corrective plan, the authority checks whether problems were properly fixed and draws up a final report with the assessment result, confirmation of corrective actions, any remaining differences with the team, and the scope of designation, which it sends to the Commission, MDCG and joint team.

Article 40 Nomination of experts for joint assessment of applications for notification

Member States and the Commission nominate qualified experts in medical device conformity assessment body evaluation to participate in assessment activities. The Commission maintains and provides Member State competent authorities access to a list of nominated experts through the electronic system, including information on their specific fields of competence and expertise.

Article 41 Language requirements

Article 42 Designation and notification procedure

Member States may designate only conformity assessment bodies that completed assessment under Article 39 and meet Annex VII requirements, and must notify the Commission and other Member States through the electronic database specifying scope and device types. Within 28 days, Member States or the Commission may raise written objections; if none is raised, the Commission publishes within 42 days. If objections are raised, the Commission submits to the MDCG within 10 days, which gives its opinion within 40 days; the notifying Member State then responds within 40 days, and the Commission publishes within 14 days.

Article 43 Identification number and list of notified bodies

The Commission assigns an identification number to each notified body whose notification becomes valid, using a single number even when designated under multiple Union acts; bodies previously notified under earlier directives retain their original numbers if successfully designated. The Commission makes the list of notified bodies, their identification numbers, and the devices they are designated for publicly accessible in NANDO and on the electronic system, keeping it current.

Article 44 Monitoring and re-assessment of notified bodies

Notified bodies must inform the competent authority within 15 days of relevant changes affecting their compliance with Annex VII requirements or ability to conduct conformity assessment. The competent authority shall monitor notified bodies and their subsidiaries and subcontractors for ongoing compliance, incorporate data from market and post-market surveillance and complaints from all Member States into its oversight, and may conduct unannounced or targeted inspections when necessary; other Member States or the Commission may request information from a notified body on conformity assessment it carried out, with the body responding within 15 days and the authority ensuring resolution unless there is legitimate reason not to do so. A complete re-assessment determining ongoing compliance with Annex VII requirements must occur three years after designation and subsequently every four years, conducted jointly by the designating Member State's authority and an assessment team; Member States must report annually to the Commission and Medical Device Coordination Group on monitoring activities, with outcomes made publicly available through an electronic system.

Article 45 Review of notified body assessment of technical documentation and clinical evaluation documentation

The authority responsible for notified bodies must review a representative and appropriately justified sample of assessments performed by notified bodies, particularly those of high-risk devices, both off-site and on-site using common specifications, examining procedures, documentation and conclusions drawn by the notified body. These reviews form part of the re-assessment process and joint assessment activities, and the Medical Device Coordination Group may recommend adjusting the sampling scope based on market surveillance data and emerging safety concerns. The Commission may establish implementing acts specifying detailed arrangements for coordinating these reviews.

Article 46 Changes to designations and notifications

When a notified body ceases activities, it must inform the responsible authority and manufacturers, with certificates remaining valid for a maximum nine months if another notified body assumes responsibility and completes assessment by the deadline; certificates of notified bodies failing to meet Annex VII requirements may be suspended, restricted or partially withdrawn by the authority, which must inform the notified body within ten days and publish changes in the relevant electronic system. Upon designation changes, the authority must assess impact on issued certificates, require suspension or withdrawal of unduly issued certificates within a reasonable timeframe, report findings within three months, and inform manufacturers' competent authorities of certificates requiring suspension or withdrawal. When designation is suspended or restricted, existing certificates remain valid if the responsible authority confirms no safety issues exist within one month and outlines remedial actions, or if the authority confirms no new certificates will be issued during suspension and that the notified body can monitor existing certificates, otherwise a qualified replacement must assume functions; when designation is withdrawn, certificates remain valid for nine months if the competent authority finds no safety issues and another notified body assumes immediate responsibility and completes assessment within twelve months, with possible three-month extensions not exceeding twelve months total.

Article 47 Challenge to the competence of notified bodies

The Commission and MDCG investigate concerns about notified bodies, their subsidiaries or subcontractors meeting requirements in Annex VII. Where Commission determines non-compliance, it requests corrective measures from the notifying Member State, and may suspend, restrict or withdraw designation if not taken.

Article 48 Peer review and exchange of experience between authorities responsible for notified bodies

The Commission organizes experience exchange and coordination between national authorities responsible for notified bodies, including best practices, guidance, expert training, monitoring of designation trends, and a peer review mechanism. Authorities must participate in peer review every three years.

Article 49 Coordination of notified bodies

The Commission ensures a coordination group of notified bodies for medical devices exists and meets at least annually. Notified bodies participate in this group's work.

Article 50 List of standard fees

Notified bodies must establish and publicly disclose lists of their standard fees for conformity assessment activities.

Article 51 Classification of devices

Devices must be assigned to classes I, IIa, IIb, or III based on their intended purpose and inherent risks, following the classification rules in Annex VIII. Disputes between manufacturers and notified bodies over classification are decided by the competent authority of the Member State where the manufacturer is registered, or where the manufacturer's authorised representative is registered if the manufacturer has no Union registration. If the notified body is in a different Member State, the authority consults the authority that designated that body.

Article 52 Conformity assessment procedures

Before placing devices on the market or putting into service, manufacturers must assess conformity according to specified procedures based on device class: Class III devices use Annex IX or optionally Annex X with XI; Class IIb devices use Annex IX (assessing at least one representative device per generic group, or every device for most implants) or optionally Annex X with XI; Class IIa devices use Annex IX (assessing at least one representative per category) or optionally Annexes II and III with Annex XI; Class I devices use EU declaration of conformity with technical documentation, except sterile, measuring or reusable surgical instruments which use Annex IX or XI Part A with limited notified body involvement. Custom-made device manufacturers follow Annex XIII procedures and draw up a statement; Class III custom-made implantable device manufacturers also follow Chapter I of Annex IX or Part A of Annex XI conformity assessment. Additional assessment procedures apply for sterile devices, devices with measuring functions, and reusable surgical instruments per referenced Annexes.

Article 53 Involvement of notified bodies in conformity assessment procedures

Allows manufacturers to apply to a notified body of their choice if designated for the relevant device type, but prohibits parallel applications to multiple notified bodies for the same procedure. Requires manufacturers to declare prior application withdrawals and refused applications to any notified body. Notified bodies must remain independent from pressures or inducements and maintain professional integrity and technical competence.

Article 54 Clinical evaluation consultation procedure for certain class III and class IIb devices

Requires notified bodies to follow clinical evaluation consultation procedures per Annex IX or X when assessing class III implantable devices and class IIb active devices intended to administer or remove medicinal products. Exceptions to this requirement exist for certificate renewals, modified devices where modifications do not adversely affect benefit-risk, or devices where clinical evaluation principles are addressed in relevant common specifications. The Commission must prepare annual overviews and report to Parliament and Council by 27 May 2025.

Article 55 Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices

Requires notified bodies to notify competent authorities of certificates for devices assessed per Article 54(1), submitting safety and clinical performance summaries, assessment reports, instructions for use, and expert panel opinions through the electronic system. Competent authorities and the Commission may conduct further procedures based on reasonable concerns, and the MDCG or Commission may request scientific advice from expert panels regarding device safety and performance.

Article 56 Certificates of conformity

Notified body certificates must be issued in an official Union language and contain minimum content per Annex XII, remaining valid for up to five years with possible extension in further five-year periods based on reassessment. Notified bodies may restrict intended purpose to certain patient groups or require specific post-market clinical follow-up studies, and may suspend, withdraw or restrict certificates where requirements are no longer met, with information on all certificates entered into the electronic system and made publicly accessible.

Article 57 Electronic system on notified bodies and on certificates of conformity

Requires the Commission to establish and manage an electronic system collating information on notified body subsidiaries, experts, notifications, certificates, conformity assessment notifications, application withdrawals or refusals, and safety and clinical performance summaries. The system information is accessible to competent authorities, the Commission, relevant notified bodies, and where specified in this Regulation or Regulation 2017/746, to the public.

Article 58 Voluntary change of notified body

Requires an agreement between manufacturer, incoming notified body and outgoing notified body when changing providers, covering the date certificates become invalid, duration of use of outgoing body identification number, document transfer and confidentiality, reassignment date of conformity assessment tasks, and last serial or lot number for outgoing body responsibility. The outgoing notified body must withdraw certificates on the date they become invalid.

Article 59 Derogation from the conformity assessment procedures

A competent authority may authorise placing a specific device on the market or into service without completing the conformity assessment procedures if this serves the public health, patient safety or health interest. Member States must inform the Commission and other Member States when granting such authorisation for uses beyond a single patient. The Commission may extend an authorisation to the entire Union for a limited period in exceptional public health circumstances, or immediately if there are urgent grounds relating to human health and safety.

Article 60 Certificate of free sale

On export request, the Member State where the manufacturer or authorised representative is registered shall issue a certificate confirming the entity's registration and that the device bearing CE marking complies with this Regulation and may be sold in the Union. The certificate must include the Basic UDI-DI and, where applicable, the unique number of any notified body certificate. The Commission may establish a model certificate by implementing acts, considering international practice.

Article 61 Clinical evaluation

Manufacturers must base conformity with general safety and performance requirements on sufficient clinical evidence and evaluate the benefit-risk ratio, specifying and justifying the required evidence level; for class III and certain class IIb devices, manufacturers may consult an expert panel. Clinical evaluation must include critical evaluation of relevant scientific literature, clinical investigation results, and alternative treatments, with equivalence to existing devices and compliance with safety requirements demonstrated. For implantable and class III devices, clinical investigations are generally required unless the device is a modification of an existing marketed device by the same manufacturer with demonstrated equivalence endorsed by the notified body, or the manufacturer has a contractual right to ongoing access to technical documentation and the original evaluation complied with this Regulation; clinical investigations are not required for devices previously marketed under earlier directives with sufficient data and compliant evaluation, or for certain specified devices like sutures and dental components.

Article 62 General requirements regarding clinical investigations conducted to demonstrate conformity of devices

Clinical investigations to demonstrate device conformity must establish proper design, manufacture, packaging, intended performance, claimed clinical benefits and acceptable safety, and must be scientifically valid with ethics committee review including at least one lay member. Non-union sponsors must establish a union legal representative (or contact person for single-member-state investigations), and investigations must protect vulnerable populations, obtain informed consent with contact details, ensure anticipated benefits justify foreseeable risks with continuous monitoring, use qualified medical supervision, minimise pain and discomfort with defined thresholds, avoid undue influence, use devices conforming to general safety requirements, and meet Annex XV requirements. Participants may withdraw consent at any time without detriment, though withdrawal does not affect prior activities or data use based on prior consent, and investigators must possess necessary scientific knowledge and experience while other personnel must be qualified in their medical field and clinical research methodology.

Article 63 Informed consent

Informed consent must be written, dated and signed by the interviewer and the participant or their legal representative after they are duly informed, or if the participant cannot write, recorded through appropriate alternative means with at least one impartial witness. The participant must be given adequate time to decide and receive a copy of the consent document or record. Information provided must enable participants to understand the investigation's nature, objectives, benefits, risks, implications, their rights and protections including the right to refuse or withdraw without detriment, the investigation conditions and expected duration, and alternative treatments.

Article 64 Clinical investigations on incapacitated subjects

A clinical investigation involving incapacitated subjects who have not given or refused informed consent before losing capacity may proceed only if their legal representative consents, they receive information suited to their understanding, their explicit refusal or withdrawal wish is respected, no incentives or financial inducements are given except for direct expense and earnings compensation, the investigation is essential for incapacitated subjects with no comparable alternative data available, relates directly to their medical condition, and produces expected direct benefit outweighing risks and burdens. Incapacitated subjects should participate as far as possible in the informed consent procedure.

Article 65 Clinical investigations on minors

Clinical investigations may include minors only if their legally designated representative consents; minors receive information in an age-appropriate way from staff trained in working with children; minors capable of forming opinions can refuse or withdraw at any time; only expenses and earnings-related compensation is permitted; the investigation must concern a condition affecting only minors or be essential to validate data from other groups; the investigation relates to the minor's condition or can only be done on minors; expected direct benefit must outweigh risks and burdens; minors participate in consent procedures according to their maturity; and minors reaching legal competence must give express consent to continue.

Article 66 Clinical investigations on pregnant or breastfeeding women

Clinical investigations involving pregnant or breastfeeding women require the investigation to offer potential direct benefit to the woman, embryo, foetus or child after birth that outweighs risks and burdens, with special care to protect the child's health in breastfeeding cases, and no incentives or inducements except direct expense and earnings compensation. These conditions apply in addition to those in Article 62(4).

Article 67 Additional national measures

Member States may maintain their own additional requirements for clinical investigations involving military personnel, persons deprived of liberty, persons barred by judicial decision, or persons in residential care institutions.

Article 68 Clinical investigations in emergency situations

In sudden life-threatening or serious medical emergencies, informed consent may be provided after initial treatment if the situation prevents prior consent, scientific grounds exist for direct clinical benefit, prior consent cannot be obtained within the therapeutic window from the subject or representative, the investigator is unaware of prior objections, the investigation directly relates to the subject's condition and can only be conducted in emergencies, and the investigation poses minimal risk and burden compared to standard treatment; after the emergency intervention, consent must be sought to continue participation. For incapacitated subjects and minors, the investigator must seek consent from the legally designated representative; for other subjects, consent is sought from whichever party can give it sooner, and if the representative initially consents, the subject must give consent when capable. Subjects or their representatives who refuse may be informed of their right to object to using data from the investigation.

Article 69 Damage compensation

Member States must ensure compensation systems exist for any harm suffered by subjects in clinical investigations on their territory, using insurance, guarantees, or equivalent arrangements suited to the nature and extent of risks. Sponsors and investigators must use the appropriate system for the Member State where the investigation is conducted.

Article 70 Application for clinical investigations

Sponsors must submit applications through an electronic system generating a unique Union-wide identification number, and the Member State must notify within 10 days whether the investigation is in scope and documentation is complete; sponsors must update the system within one week of documentation changes. For investigational class I devices or non-invasive class IIa and IIb devices, sponsors may start immediately after validation unless an ethics committee issues a valid negative opinion; for other investigational devices, sponsors may start after Member State authorization, which must be notified within 45 days of validation (extendable by 20 days for expert consultation), unless a valid negative ethics opinion exists. The Commission may adopt delegated and implementing acts on documentation requirements and uniform application.

Article 71 Assessment by Member States

Member States must ensure that persons validating, assessing or deciding on clinical investigation applications are independent of the sponsor, investigators and financing parties, free from undue influence, and collectively possess necessary qualifications and experience. States must assess whether remaining risks to subjects or third parties are justified against expected clinical benefits, examining: compliance with safety and performance requirements; whether risk minimization matches harmonised standards or provides equivalent protection; adequacy of installation, putting into service and maintenance measures; reliability and robustness of clinical data; meeting Annex XV requirements; sterilisation validation for sterile devices; and safety, quality and usefulness of animal or human origin components or medicinal product substances. Authorisation must be refused if the dossier is incomplete, the device or documents do not match scientific knowledge or are unsuitable for generating safety or benefit evidence, Article 62 requirements are unmet, or assessment findings are negative; appeal procedures must be provided.

Article 72 Conduct of a clinical investigation

Article 73 Electronic system on clinical investigations

The Commission must establish and maintain an electronic system for assigning single identification numbers for clinical investigations, submitting applications and notifications for clinical investigations, exchanging investigation information between Member States and the Commission, receiving sponsor-provided information including investigation reports, and reporting serious adverse events and device deficiencies. The system must be interoperable with the EU database for medicinal product clinical trials for combined investigations. Exchange information between Member States and Commission is not publicly accessible; other information is public unless confidentiality is justified for personal data protection, commercially confidential information, or effective supervision purposes, but no subject personal data shall be publicly available.

Article 74 Clinical investigations regarding devices bearing the CE marking

For post-market clinical follow-up investigations of CE-marked devices involving additional invasive or burdensome procedures beyond normal use, sponsors must notify Member States at least 30 days before commencement through the electronic system, including documentation from Annex XV Chapter II; specified provisions of Article 62(4), Articles 75-77 and 80(5), and Annex XV apply. For clinical investigations assessing CE-marked devices outside their intended purpose, Articles 62 through 81 apply in full.

Article 75 Substantial modifications to clinical investigations

Sponsors intending modifications likely to substantially impact subject safety, health or rights or clinical data robustness or reliability must notify the relevant Member State(s) within one week through the electronic system with updated documentation clearly identifying changes. The Member State shall assess substantial modifications according to Article 71 procedures. Sponsors may implement modifications earliest 38 days after notification, unless the Member State refuses based on Article 71(4) grounds or public health, safety or policy considerations, or unless an ethics committee issues a negative opinion valid for the entire Member State.

Article 76 Corrective measures to be taken by Member States and information exchange between Member States

Member States that consider Regulation requirements are not met may revoke clinical investigation authorisation, suspend or terminate the investigation, or require the sponsor to modify any investigation aspect. Before taking measures, except where immediate action is required, the Member State must request the sponsor's or investigator's opinion within seven days. When a Member State takes corrective measures, refuses a clinical investigation, is notified of early termination on safety grounds, or receives a sponsor's withdrawal of application, it must communicate the decision and grounds to all Member States and the Commission through the electronic system.

Article 77 Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination

Sponsors must notify the relevant Member State within 15 days (or 24 hours for safety-based halts affecting all Member States) of temporarily stopping or prematurely ending a clinical investigation, and within 15 days of the investigation ending in each Member State if conducted across multiple states. The clinical investigation report and summary must become publicly accessible through an electronic system when the device is registered under Article 29 and before market placement, or immediately upon submission if the investigation is early terminated or halted; if the device is not registered within one year of entry into the system, they become publicly accessible at that one-year point.

Article 78 Coordinated assessment procedure for clinical investigations

Sponsors may submit a single application for multi-state clinical investigations via an electronic system; within six days, Member States must agree on a coordinating Member State, or the sponsor's proposed state assumes the role. Each Member State may request additional information once with a response deadline not exceeding 12 days, which suspends the final assessment deadline; the coordinating Member State may extend assessment periods by an additional 50 days for high-risk device classes. A coordinating Member State's positive conclusion binds all other Member States unless they disagree on grounds of inferior treatment compared to standard practice, national law infringement, or safety and data robustness concerns, which must be communicated with detailed justification; a negative conclusion is deemed agreed by all Member States.

Article 79 Review of coordinated assessment procedure

By 27 May 2026, the Commission must report to the European Parliament and Council on experience gained from the coordinated assessment process and, where necessary, propose amendments to relevant provisions.

Article 80 Recording and reporting of adverse events that occur during clinical investigations

Sponsors must fully record critical adverse events, serious adverse events, device deficiencies that could have become serious, and new findings related to these events. Sponsors must report without delay to all Member States where the investigation occurs any serious adverse event with a causal relationship or reasonably possible relationship to the investigational device, comparator or investigation procedure, device deficiencies of that type, and new findings, with reporting timelines reflecting event severity; incomplete initial reports may be followed by complete reports. Sponsors must also report events from third country investigations under the same plan, and under single applications, reports go through the electronic system to all Member States, with the coordinating Member State directing a coordinated assessment while other Member States retain their own evaluation rights.

Article 81 Implementing acts

The Commission may establish through implementing acts detailed arrangements and procedural aspects for this Chapter, including harmonised electronic forms for applications and notifications, functioning of the electronic system, reporting forms for serious adverse events and device deficiencies, reporting timelines based on event severity, and uniform application of clinical evidence requirements for safety and performance.

Article 82 Requirements regarding other clinical investigations

Article 83 Post-market surveillance system of the manufacturer

Manufacturers must establish and maintain a proportionate post-market surveillance system integrated with quality management, suited to actively and systematically gathering and analysing data on device quality, performance and safety throughout its lifetime to identify preventive and corrective actions. Data must be used to update benefit-risk and risk management information, design and manufacturing information, instructions for use, labelling, clinical evaluation, safety summaries, and to identify needs for corrective actions, usability improvements, and trends; technical documentation must be updated accordingly, and manufacturers must inform competent authorities and notified bodies of identified needs and report serious incidents or field safety corrective actions in accordance with Article 87.

Article 84 Post-market surveillance plan

The post-market surveillance system must be established through a plan with requirements specified in Annex III; this plan must form part of the technical documentation for non-custom devices.

Article 85 Post-market surveillance report

Manufacturers of class I devices must prepare post-market surveillance reports summarising results, conclusions and analyses of post-market surveillance data with rationale and descriptions of preventive and corrective actions taken, update the report when necessary, and make it available to competent authorities upon request.

Article 86 Periodic safety update report

Manufacturers of class IIa, IIb and III devices must prepare periodic safety update reports (PSURs) for each device summarising results, conclusions and analyses of post-market surveillance data with rationale and descriptions of preventive and corrective actions, setting out benefit-risk conclusions, main PMCF findings, and device sales volume and population characteristics; manufacturers of class IIb and III devices must update PSURs at least annually, while class IIa manufacturers must update at least every two years, except for custom-made devices; manufacturers of class III or implantable devices must submit PSURs through the electronic system to the notified body involved in conformity assessment, while other manufacturers must make PSURs available to the notified body and competent authorities upon request.

Article 87 Reporting of serious incidents and field safety corrective actions

Manufacturers must report serious incidents and field safety corrective actions through an electronic system: serious incidents within 15 days of awareness, or immediately or within 2 days for public health threats, or within 10 days for incidents involving death or serious deterioration; field safety corrective actions must be reported in advance or immediately if urgency requires. Manufacturers may submit periodic summary reports instead of individual reports for similar incidents with identified root cause or implemented corrective action, with coordinating competent authority agreement on format, content and frequency. Member States shall encourage healthcare professionals, users and patients to report suspected serious incidents and record them centrally.

Article 88 Trend reporting

Manufacturers must report any statistically significant increase in frequency or severity of non-serious incidents or expected side-effects that could affect the benefit-risk analysis and create unacceptable risks compared to intended benefits, with the observation period and methodology specified in the post-market surveillance plan. Competent authorities may assess trend reports and require manufacturers to adopt appropriate measures; each competent authority shall inform the Commission, other competent authorities and the notified body of assessment results and measures taken.

Article 89 Analysis of serious incidents and field safety corrective actions

Following serious incident reports, manufacturers must immediately investigate and perform risk assessment cooperating with competent authorities without altering devices; competent authorities must evaluate all serious incident or field safety corrective action information in their territory, considering factors such as causality, harm probability and severity, and may intervene or conduct independent investigations. For devices containing medicinal product substances or human tissue derivatives, the evaluating or coordinating competent authority must inform relevant national authorities or EMA; manufacturers must provide field safety notices to users in official Union languages without delay, with draft content for competent authority comment, including device identification by UDI, manufacturer identification by SRN if issued, clear explanation referencing device malfunctions and risks, and specific required actions. When serious incidents or clusters affect the same device across multiple Member States or proposed corrective actions apply in multiple Member States, competent authorities must coordinate their assessments, designating a coordinating authority from the manufacturer's registered Member State unless otherwise agreed, which must inform the manufacturer, other authorities and Commission through an electronic system; other authorities retain rights to perform their own assessments and adopt measures, keeping the coordinating authority and Commission informed.

Article 90 Analysis of vigilance data

The Commission and Member States must actively monitor the electronic system to detect trends, patterns or signals revealing new risks or changes in anticipated risk frequency that alter the benefit-risk balance; competent authorities must then inform manufacturers to undertake necessary corrective actions.

Article 91 Implementing acts

The Commission may adopt implementing acts, after consulting the Medical Device Coordination Group, to establish detailed arrangements and procedures for Articles 85-90 and 92, including specifications for serious incident classification, reporting timelines, electronic and non-electronic forms, competent authority coordination, and information exchange.

Article 92 Electronic system on vigilance and on post-market surveillance

The Commission shall establish and manage an electronic system to collect reports on serious incidents, field safety corrective actions, periodic summaries, trends, PSURs, and field safety notices from manufacturers, and to facilitate information exchanges between competent authorities and the Commission. Access shall be provided to Member State competent authorities, the Commission, notified bodies for devices they certified, healthcare professionals, the public, and third country authorities under reciprocal data protection arrangements. Reports on serious incidents, trends, field safety corrective actions, periodic summaries, and manufacturer and incident information must be automatically transmitted through the system upon receipt to relevant competent authorities and to the notified body that issued the relevant device certificate.

Article 93 Market surveillance activities

Competent authorities must perform conformity checks on devices based on risk assessment and vigilance data, develop annual surveillance plans with adequate resources, request documentation and samples from economic operators, conduct announced and unannounced inspections, confiscate or destroy devices presenting unacceptable risk or falsified devices, and prepare inspection reports with findings and corrective actions that are shared with the inspected operator and entered into an electronic system. Member State competent authorities must coordinate market surveillance activities with each other and the Commission, share results for harmonized oversight, agree on work-sharing and specialization where applicable, and cooperate by sharing relevant information.

Article 94 Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance

When competent authorities have reason to believe a device may present an unacceptable risk to health or safety or otherwise fails to comply with this Regulation, they shall evaluate the device for all applicable requirements. Relevant economic operators must cooperate with competent authorities during evaluation.

Article 95 Procedure for dealing with devices presenting an unacceptable risk to health and safety

Competent authorities must require manufacturers and other economic operators to take proportionate corrective action such as restricting market availability, imposing requirements, withdrawing or recalling devices within a defined period upon finding unacceptable risk, and shall notify the Commission, other Member States and notified bodies immediately. If economic operators fail to act adequately, authorities must take measures to prohibit, restrict, withdraw or recall the device on their national market and notify others of non-compliance and risk details. If neither a Member State nor the Commission objects within two months of notification about risk mitigation measures, those measures are deemed justified and all Member States must promptly implement corresponding restrictive or prohibitive measures.

Article 96 Procedure for evaluating national measures at Union level

The Commission evaluates national measures when Member States or the Commission objects within two months, and may decide by implementing acts whether the measure is justified. If the Commission finds the measure justified, all Member States apply it; if unjustified, the Member State withdraws it. Measures are deemed justified if the Commission does not decide within eight months.

Article 97 Other non-compliance

Competent authorities must require economic operators to remedy non-compliance within a reasonable defined period when a device does not meet requirements but does not present unacceptable risk. If not remedied within the period, the Member State must immediately restrict or prohibit market availability or ensure recall or withdrawal and inform the Commission and other Member States. The Commission may specify appropriate measures for given types of non-compliance.

Article 98 Preventive health protection measures

A Member State may take necessary justified measures to prohibit, restrict or subject devices to particular requirements, or withdraw or recall them, based on evaluation indicating potential risk. The Member State must immediately notify the Commission and other Member States. The Commission assesses the measures with MDCG input and may decide their justification by implementing acts; measures are deemed justified if the Commission does not decide within six months.

Article 99 Good administrative practice

Competent authorities must state exact grounds for measures adopted under Articles 95 to 98, notify the economic operator with information on remedies and deadlines, and publish general measures. Except when immediate action is necessary due to unacceptable risk, the economic operator must be given opportunity to make submissions within an appropriate defined period before measures are adopted; if action taken without submissions, the operator must be given opportunity to do so and the action reviewed promptly. Measures must be immediately withdrawn or amended if the operator demonstrates effective corrective action and compliance.

Article 100 Electronic system on market surveillance

The Commission and Member States shall establish and operate an electronic system to gather and handle surveillance data, including summaries of surveillance activities, inspection reports, information on devices posing unacceptable health risks, product non-compliance data, preventive health measures, and reviews of market surveillance. This information must be transmitted immediately to all relevant competent authorities and notified bodies, and made accessible to Member States and the Commission. Data shared between Member States remains confidential when disclosure could damage surveillance effectiveness or inter-state cooperation.

Article 101 Competent authorities

Member States must designate competent authorities responsible for implementing the regulation and provide them with necessary powers, resources, equipment and knowledge. Member States must inform the Commission of the authorities' names and contact details, which the Commission publishes.

Article 102 Cooperation

Competent authorities across Member States shall work together with the Commission, which shall facilitate the exchange of information needed for uniform application of this Regulation. Member States shall also participate in international regulatory cooperation initiatives for medical devices where appropriate, with Commission support.

Article 103 Medical Device Coordination Group

The MDCG is established with each Member State appointing one member and alternate with expertise in medical devices and one member and alternate with expertise in in vitro diagnostic devices for three-year renewable terms, or optionally combining both areas in single appointments. The MDCG meets regularly and when situations require, decides by consensus or majority vote with dissenting positions recorded, is chaired by a Commission representative who does not vote, may invite experts and third parties, may establish sub-groups with industry, healthcare professional, laboratory, patient and consumer organization observers, and shall adopt rules of procedure covering opinion adoption, task delegation, conflict of interests and sub-group functioning. The MDCG performs tasks in Article 105 and Article 99 of Regulation 2017/746.

Article 104 Support by the Commission

The Commission shall facilitate cooperation between national competent authorities by organizing exchanges of experience, providing technical and scientific support to the Medical Device Coordination Group and its sub-groups, and organizing and participating in meetings with appropriate follow-up.

Article 105 Tasks of the MDCG

The Medical Device Coordination Group shall assess conformity assessment bodies and notified bodies, advise the Commission on notified body coordination, develop harmonized guidance on designation and monitoring of notified bodies, clinical evaluations and standards, monitor technical progress against safety requirements, assist Member States in coordination activities regarding classification and vigilance, provide advice on implementation issues, and contribute to harmonised administrative practices across the Member States.

Article 106 Provision of scientific, technical and clinical opinions and advice

Expert laboratories must have qualified staff with device knowledge, appropriate equipment, knowledge of international standards, proper administrative organization, and ensure staff confidentiality. Expert panels for clinical evaluation perform clinical evaluation assessment tasks and may provide scientific assistance to the Commission and MDCG, develop guidance on clinical investigations and testing, develop and review clinical evaluation guidance, contribute to international standards development, and provide opinions to manufacturers, notified bodies and Member States. Expert panel members shall attempt to achieve consensus when adopting scientific opinions; if consensus fails, decisions proceed by majority vote with divergent positions documented.

Article 107 Conflict of interests

Article 108 Device registers and databanks

The Commission and Member States shall encourage establishing registers and databanks for specific device types with common principles to collect comparable information for independent evaluation of long-term safety and performance, traceability of implantable devices, or all such characteristics.

Article 109 Confidentiality

All parties implementing this Regulation must maintain confidentiality of information and data to protect personal data, commercially sensitive information and trade secrets, and effective regulatory implementation including inspections and investigations, unless disclosure serves the public interest. Information shared confidentially between competent authorities and the Commission cannot be disclosed without consent from the originating authority. These confidentiality obligations do not restrict the Commission, Member States or notified bodies from exchanging information or issuing warnings, nor do they prevent individuals from providing information required by criminal law.

Article 110 Data protection

Article 111 Levying of fees

Member States may charge fees for activities under this Regulation, provided they set fee levels transparently and based on cost-recovery principles, and notify the Commission and other Member States at least three months in advance before adopting fee structures, which must be publicly available upon request.

Article 112 Funding of activities related to designation and monitoring of notified bodies

The Commission shall pay for joint assessment activities and shall establish the scale, structure of recoverable costs and implementing rules through implementing acts adopted under the examination procedure in Article 114(3).

Article 113 Penalties

Member States shall establish rules for penalties applicable to infringements of this Regulation and ensure their implementation, with penalties being effective, proportionate and dissuasive, and shall notify the Commission of these rules and measures by 25 February 2020 and of any subsequent amendments without delay.

Article 114 Committee procedure

A Committee on Medical Devices shall assist the Commission and operate as a committee under Regulation (EU) No 182/2011, with the applicable procedure depending on whether references are made to paragraphs 2, 3 or 4 of this Article, which trigger Articles 4, 5 or 8 respectively of that Regulation.

Article 115 Exercise of the delegation

The Commission receives delegated power for five years from 25 May 2017 for specified articles, with automatic extension unless the European Parliament or Council objects three months before each period ends, and power that may be revoked at any time by either institution; the Commission must consult Member State experts before adopting delegated acts, notify both institutions, and acts enter into force unless either institution objects within three months of notification, extendable to six months.

Article 116 Separate delegated acts for different delegated powers

The Commission shall issue a distinct delegated act for each delegated power granted to it under this Regulation.

Article 117 Amendment to Directive 2001/83/EC

Article 118 Amendment to Regulation (EC) No 178/2002

Regulation (EC) No 178/2002 is amended to include medical devices under Regulation (EU) 2017/745 in the definition of products to which that regulation applies.

Article 119 Amendment to Regulation (EC) No 1223/2009

Allows the Commission to determine whether specific products fall within the definition of cosmetic product, either on its own initiative or at a Member State's request, using a regulatory procedure.

Article 120 Transitional provisions

Notifications of notified bodies under earlier directives become void from 26 May 2020, while certificates issued before 25 May 2017 remain valid until expiry or 27 May 2022 (for specific annexes), and those from 25 May 2017 remain valid up to five years or until 27 May 2024, whichever is earlier. Devices with valid earlier certificates may be marketed if they comply with earlier directives and show no significant design changes, with post-market surveillance, market surveillance, vigilance and registration following this regulation instead. For Article 54 consultation procedures, earlier provisions apply once the coordination group and expert panels are appointed, compliance with this regulation's registration provisions during the 18-month period after a specified date satisfies earlier directive requirements, and earlier manufacturer and representative authorisations retain validity.

Article 121 Evaluation

The Commission must assess how this regulation is being applied and produce an evaluation report by 27 May 2027, including progress on objectives and resources required, with particular focus on medical device traceability through unique device identifier storage.

Article 122 Repeal

Two earlier medical device directives are repealed from 26 May 2020, except for specified provisions on vigilance and clinical investigations which are repealed later, and registration provisions which are repealed 18 months later. The directives continue applying until 27 May 2025 for devices with valid earlier certificates. Two regulations on notified body competence remain in force unless subsequently repealed by the Commission.

Article 123 Entry into force and date of application

This regulation enters into force on the twentieth day after publication and applies from 26 May 2020, with exceptions: Articles 35-50 apply from 26 November 2017 for bodies applying for designation; Articles 101 and 103 apply from 26 November 2017; Article 102 applies from 26 May 2018; and provisions relating to the Eudamed database apply from six months after its full functionality is declared if not ready by 26 May 2020. Device identifier requirements apply from 26 May 2021 for implantable and class III devices, 26 May 2023 for class IIa and IIb devices, and 26 May 2025 for class I devices. The regulation binds all Member States and applies directly.