Medical Devices Regulation (EU) 2017/745

Last reviewed: October 2026 · Sources listed at the end of this page.

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices — commonly the "MDR" — is the EU framework for the placing on the market and putting into service of medical devices and their accessories. It replaced Directives 93/42/EEC (medical devices) and 90/385/EEC (active implantable medical devices). The MDR was published in the OJEU as OJ L 117, 5.5.2017, p. 1 and has applied from 26 May 2021. The application date was deferred by one year from the original 26 May 2020 by Regulation (EU) 2020/561 in response to COVID-19. Subsequent amendments extended transitional periods for legacy devices certified under the predecessor directives.

Legal status and timeline

• Adoption: 5 April 2017.
• Publication in the OJEU: 5 May 2017.
• Original date of application: 26 May 2020.
• Postponed date of application: 26 May 2021 (Regulation (EU) 2020/561).
• Extended transitional period for legacy devices (Article 120, as amended by Regulation (EU) 2023/607): devices with a certificate under Directive 93/42/EEC or 90/385/EEC that remains valid under Article 120(2) may be placed on the market until:
  • 31 December 2027: all Class III devices, and Class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
  • 31 December 2028: other Class IIb devices, Class IIa devices, and Class I devices placed on the market sterile or with a measuring function;
  • 31 December 2028: devices that needed no Notified Body under Directive 93/42/EEC, had a declaration of conformity drawn up before 26 May 2021, and need a Notified Body under the MDR (Article 120(3b)).
  The separate derogation for Class III custom-made implantable devices without an MDR certificate ended on 26 May 2026 (Article 120(3f)).
• Status in October 2026: applies; legacy devices may still be placed on the market only if the Article 120(3c) conditions are met. The first four EUDAMED modules have been mandatory since 28 May 2026 (Commission Decision (EU) 2025/2371).

Scope: products covered

Article 1 and Annex XVI of the MDR apply to:

• Medical devices as defined in Article 2(1) — instruments, software, materials, or articles intended for medical purposes including diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, or disability; investigation, replacement, or modification of anatomy or physiological processes; control of conception. The device must not achieve its principal intended action by pharmacological, immunological, or metabolic means (which would place it under medicinal product law).
• Accessories to medical devices (Article 2(2)).
• Products without an intended medical purpose listed in Annex XVI — contact lenses without corrective function, equipment for liposuction, intense pulsed light devices for skin treatment, equipment for brain stimulation, dermal fillers — brought under the MDR by Article 1(2).

Software as a medical device

Software intended for medical purposes is a medical device under MDR Article 2(1). The classification rules in Annex VIII apply, including specific Rule 11 which has placed much medical software into Class IIa, IIb, or III depending on the seriousness of the decision the software supports. Rule 11 has been one of the principal sources of difficulty in MDR transition for software developers, as it pushed many products previously self-certified under the MDD into Notified-Body-required classes.

Borderline products

The Commission's Manual on borderline and classification, which is updated periodically, addresses contested cases — software with general wellness purposes vs. medical purposes, accessories vs. consumables, the boundary with cosmetics under Regulation (EC) 1223/2009, with biocides under Regulation (EU) 528/2012, and with personal protective equipment under PPE Regulation 2016/425.

Device classification (Annex VIII)

MDR Annex VIII contains 22 rules dividing devices into four classes by risk:

• Class I — lowest risk (non-invasive devices for short-term use, most basic instruments). Sub-categories: Class I sterile (Is), Class I with measuring function (Im), Class I reusable surgical instruments (Ir). For Class I devices without these features, self-declaration applies; for Class Is, Im, and Ir, a Notified Body is required for the sterile/measuring/reprocessing aspects.
• Class IIa — medium risk (for example, most surgically invasive devices for transient use and many active devices that administer or remove substances from the body).
• Class IIb — higher medium risk (for example, many long-term implants, devices for contraception that are not implantable or long-term invasive, and diagnostic X-ray equipment).
• Class III — highest risk (active implantable devices, implantable or long-term invasive contraceptive devices, devices in direct contact with the central nervous system or central circulatory system, devices incorporating medicinal substances with an ancillary action).

Essential requirements: general safety and performance

MDR Annex I sets out the general safety and performance requirements (GSPRs), structured into three chapters:

• Chapter I — General requirements (points 1–9): the device must achieve its intended performance and be designed and manufactured so that, during normal conditions of use, it is suitable and its risks are acceptable when weighed against benefits.
• Chapter II — Requirements regarding design and manufacture (points 10–22): chemical, physical, and biological properties; infection and microbial contamination; devices incorporating substances; devices incorporating biological materials; devices incorporating nanomaterials; devices and external influences; devices with diagnostic or measuring function; protection against radiation; software; active devices.
• Chapter III — Requirements regarding information supplied with the device (point 23): label and instructions for use.

Conformity assessment procedures

Articles 52–53 and Annexes IX, X, XI set the routes:

• Class I (not sterile, not measuring, not reusable surgical) — Article 52(7); the manufacturer draws up the technical documentation under Annexes II and III and issues the EU declaration of conformity under Article 19, without Notified Body involvement.
• Class I sterile, with measuring function, or reusable surgical — Annex IX Chapters I and III, or Annex XI Part A, with Notified Body involvement limited to the specific aspect (sterility, measuring, reprocessing).
• Class IIa, IIb — Annex IX Chapters I and III (QMS + assessment of the technical documentation of representative devices); alternatively, for Class IIa, technical documentation under Annexes II and III coupled with Annex XI Section 10 or 18, and, for Class IIb, Annex X (type-examination) coupled with Annex XI. For Class IIb implantable devices the technical documentation of every device is assessed, except the types listed in Article 52(4). Delegated Regulation (EU) 2026/1359 extended that list; it has been in force since 19 July 2026.
• Class III — Annex IX, or Annex X coupled with Annex XI (Article 52(3)); for implantable Class III and Class IIb active devices intended to administer/remove a medicinal product, additional consultation procedures with the Commission's expert panels under Article 54 ("clinical evaluation consultation procedure").

Notified Body certificates are valid for the period they indicate, which may not exceed five years, and may be extended for further periods of up to five years each following re-assessment (Article 56(2)).

See conformity assessment modules and Notified Bodies. About 50 Notified Bodies were reported as designated under the MDR in 2026; NANDO holds the current list. To check a number on a label, see CE number lookup.

Technical documentation

Annexes II and III set the technical documentation requirements:

• Annex II — Technical documentation: device description (1), information to be supplied (2), design and manufacturing information (3), GSPR mapping (4), benefit-risk analysis and risk management (5), product verification and validation including clinical evaluation per Annex XIV (6).
• Annex III — Technical documentation on post-market surveillance: post-market surveillance plan, Periodic Safety Update Report (PSUR), trend reporting, post-market clinical follow-up (PMCF).

The documentation must be retained for 10 years after the last device was placed on the market, or 15 years for implantable devices (Article 10(8)).

EU Declaration of Conformity

Article 19 and Annex IV require the Declaration to include the Basic UDI-DI of the device, the manufacturer's Single Registration Number (SRN), the risk class, references to any common specifications used, and the Notified Body's name, identification number and certificate references. See EU Declaration of Conformity. The Declaration must be translated into the official Union language or languages required by the Member States where the device is made available (Article 19(1)).

Marking and labelling

Article 20 requires the CE marking; the four-digit Notified Body identification number follows the mark wherever a Notified Body took part in the conformity assessment, so basic Class I devices carry no number. Beyond the CE mark, the label must include (Annex I, Section 23):

• Device name and intended purpose;
• Manufacturer's name or registered trade name and the address of its registered place of business (and the Authorised Representative's, where the manufacturer is outside the Union);
• UDI carrier (Article 27) on the label and on each higher level of packaging;
• Indication that the product is a medical device;
• Where applicable, "sterile", "single use", expiry date;
• For implantable devices, the implant card (Article 18) provided to patients.

UDI and EUDAMED

The Unique Device Identification system (Articles 27–30) requires each device to have a UDI consisting of a Device Identifier (DI) and a Production Identifier (PI). The UDI is registered in EUDAMED — the European Database on Medical Devices established under Article 33. EUDAMED has six modules: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, Clinical Investigations and Performance Studies, Vigilance and Post-Market Surveillance, and Market Surveillance. Under the gradual roll-out introduced by Regulation (EU) 2024/1860, each module becomes mandatory six months after the Commission publishes a notice of its functionality. Commission Decision (EU) 2025/2371 (OJ 27.11.2025) confirmed the Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance modules, which have therefore been mandatory since 28 May 2026; the Vigilance and Clinical Investigations/Performance Studies modules are not yet mandatory, because no notice has been published for them.

Article 123(3) sets the follow-on deadlines, counted from the notice of 27 November 2025:

• 28 May 2026: new devices must be registered before they are placed on the market, and actors must be registered.
• 28 November 2026: Article 123(3)(e) gives manufacturers 12 months to enter device data for devices first placed on the market before 28 May 2026, including legacy devices, if units continue to be placed on the market after that date.
• 28 May 2027: Article 123(3)(ea) gives Notified Bodies 18 months to enter certificate information. For earlier certificates only the latest certificate and any later decision need to be entered.

Person Responsible for Regulatory Compliance (PRRC)

Article 15 requires each manufacturer (and, by Article 15(6), each Authorised Representative) to have at least one person responsible for regulatory compliance with specified qualifications: a diploma in a relevant field (law, medicine, pharmacy, engineering) plus one year's professional experience, or four years' professional experience. Micro and small enterprises are not required to have the PRRC within the organisation but must have a person continuously and permanently at their disposal.

Recent and upcoming changes

• Regulation (EU) 2023/607 (15 March 2023) — extended transitional periods for MDD-certified legacy devices.
• Regulation (EU) 2024/1860 (13 June 2024; OJ 9 July 2024) — introduced gradual rollout of EUDAMED's mandatory use module by module. It also added Article 10a, applicable from 10 January 2025: manufacturers must, other than in exceptional circumstances, give at least 6 months' notice of an interruption or discontinuation of supply that could cause serious harm.
• Delegated Regulations (EU) 2026/1359 and 2026/1451 (OJ 29 June 2026; in force 19 July 2026) — added well-established technologies to the lists in Article 52(4) (technical documentation assessment) and Article 61(6)(b) (exemption from clinical investigations). A clinical evaluation is still required.
• UDI for eyewear — Delegated Regulation (EU) 2023/2197 on contact lenses applies from 9 November 2026 (date set by Delegated Regulation (EU) 2025/788). Delegated Regulation (EU) 2025/1920 on spectacle frames, spectacle lenses and ready-to-wear reading spectacles applies from 1 November 2028.
• Common specifications under Article 9 — adopted for the products without an intended medical purpose listed in Annex XVI (Implementing Regulation (EU) 2022/2346).
• Proposed targeted revision. On 16 December 2025 the Commission proposed amending the MDR and IVDR (COM(2025) 1023, procedure 2025/0404(COD)), addressing certification, administrative burden and innovation pathways, including replacing the five-year limit on certificate validity with periodic reviews. It is not law and may change. As of late October 2026 we found no report of a Parliament committee vote or a Council general approach: the rapporteur's draft report dates from June 2026, and the Council's working party was still examining the text.
• Great Britain: on 21 October 2026, after consulting from 16 February to 10 April 2026, the UK Government confirmed that CE-marked devices will be accepted long term. The change still needs legislation. Until then the dates in the Medical Devices (Amendment) (Great Britain) Regulations 2023 stand: 30 June 2028 for MDD/AIMDD devices (or earlier certificate expiry) and 30 June 2030 for IVDD, EU MDR and EU IVDR devices. Published commentary reports that MDD devices will be accepted only until the end of the EU transition. See CE marking vs UKCA.

Related legislation

• In Vitro Diagnostic Regulation 2017/746 — companion regulation for IVDs.
• Directive 2001/83/EC on medicinal products — for combination products with a primary medicinal mode of action.
• Radio Equipment Directive 2014/53/EU — for medical devices with intentional radio emission, applies in parallel.
• EMC Directive 2014/30/EU — does not apply (excluded under Article 2(3) of the EMC Directive as more specific Union legislation; EMC requirements are within Annex I of the MDR).
• Directive (EU) 2024/2853 on liability for defective products — applies to products placed on the market or put into service after 9 December 2026. Directive 85/374/EEC is repealed from that date but continues to apply to earlier products.

Common errors

• Continuing to place devices on the market under MDD certificates without meeting Regulation 2023/607 conditions. Article 120(3c) requires continued compliance with the old directive, no significant change in design or intended purpose, no unacceptable risk, an MDR quality management system by 26 May 2024, a formal application to a Notified Body by 26 May 2024, and a written agreement signed by 26 September 2024.
• Classification under MDD rules. The MDR's Annex VIII rules differ substantially from MDD Annex IX; Class I devices under MDD may be Class IIa or higher under MDR (notably software under Rule 11).
• Missing PRRC. Failure to designate a Person Responsible for Regulatory Compliance is an organisational non-compliance.
• Inadequate clinical evaluation. Annex XIV requires a structured clinical evaluation; reliance on equivalence to another device is subject to the strict technical, biological and clinical criteria of Annex XIV, Part A, Section 3; for implantable and Class III devices, Article 61(5) additionally requires, where the equivalent device belongs to another manufacturer, a contract giving full, ongoing access to its technical documentation.
• Failure to register in EUDAMED. Manufacturers, importers, and Authorised Representatives must register in the Actor module and obtain an SRN before placing devices on the market.
• Use of CE mark without Notified Body number for non-Class I devices. Class IIa, IIb, and III devices require the four-digit identification number next to the CE mark.

Frequently asked questions

When do MDD certificates stop being usable?

Devices under a certificate kept valid by Article 120 may be placed on the market until 31 December 2027 (all Class III, and Class IIb implantable devices apart from the listed exceptions) or 31 December 2028 (other Class IIb, Class IIa, Class I sterile or measuring). This holds only if the Article 120(3c) conditions were met, including a formal application to a Notified Body by 26 May 2024 and a signed agreement by 26 September 2024. Units already lawfully placed on the market may continue to be made available.

When must a device already on the market be registered in EUDAMED?

By 28 November 2026, if the device was first placed on the market before 28 May 2026 and units continue to be placed on the market after that date. New devices must be registered before they are placed on the market.

Does a Class I device need a Notified Body?

Not if it is non-sterile, has no measuring function and is not a reusable surgical instrument: the manufacturer draws up the technical documentation and the EU declaration of conformity (Article 52(7)). For Class Is, Im and Ir devices a Notified Body assesses the sterile, measuring or reprocessing aspects only.

Has the MDR revision been adopted?

No. COM(2025) 1023 was proposed on 16 December 2025 and is still in the ordinary legislative procedure. The current MDR, including the five-year limit on certificate validity in Article 56(2), continues to apply.

Are CE-marked devices still accepted in Great Britain?

Yes. On 21 October 2026 the UK Government confirmed long-term acceptance of CE-marked devices, but the legislation had not been made at the time of this review. Northern Ireland continues to apply the EU MDR and IVDR.

Sources

• Regulation (EU) 2017/745 (MDR) — EUR-Lex consolidated text.
• Regulation (EU) 2023/607 (transitional extension) — EUR-Lex.
• Regulation (EU) 2024/1860 (EUDAMED roll-out, supply interruption) — EUR-Lex.
• Commission Decision (EU) 2025/2371 (EUDAMED notice) — EUR-Lex.
• Delegated Regulations (EU) 2026/1359 and 2026/1451 — EUR-Lex, EUR-Lex.
• COM(2025) 1023 final (proposed revision) — Commission.
• UK Government, 21 October 2026 — Government confirms indefinite recognition of CE marked medical devices.
• European Commission — Medical devices sector (DG SANTE).
• European Commission — EUDAMED.
• Medical Device Coordination Group (MDCG) guidance documents — DG SANTE.