Medical Devices Regulation (EU) 2017/745

Last reviewed: May 2026 · Legal status verified against EUR-Lex.

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: Regulation (EU) 2023/607 extended the validity of certificates issued under Directives 93/42/EEC and 90/385/EEC. Class III implantable custom-made devices have until 26 May 2026; other Class III and Class IIb implantable devices until 31 December 2027; Class IIb non-implantable, Class IIa, Class I sterile and measuring devices until 31 December 2028.
• Status in May 2026: applies; legacy MDD-certified devices continue to be placed on the market under the conditions of Regulation 2023/607.

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 under the MDR (most recent edition published in 2024) 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 (most invasive devices for transient use, devices used to administer or remove substances from the body, dental restoration materials).
• Class IIb — higher medium risk (long-term implants for non-life-threatening uses, devices for sterilisation, X-ray equipment).
• Class III — highest risk (active implantable devices, contraceptive devices, devices in contact with the central nervous system or central circulatory system, devices incorporating medicinal substances).

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); manufacturer self-declares conformity under Annex IX, Chapter I (without Section 4 Notified Body assessment).
• Class I sterile, with measuring function, or reusable surgical — Notified Body assessment limited to the specific aspect (sterility, measuring, reprocessing).
• Class IIa, IIb — Annex IX (full QMS + technical documentation assessment per device or per sample), or Annex XI (type-examination + production or product quality assurance).
• Class III — Annex IX, with assessment of each device's technical documentation; 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").

See conformity assessment modules and Notified Bodies. MDR-designated Notified Bodies number around 50 in May 2026, down from approximately 80 under the predecessor directives.

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, manufacturer's Single Registration Number (SRN), references to the Notified Body certificates, address where the technical documentation is kept, and conditions of validity. See EU Declaration of Conformity. The Declaration must be made available in all languages required by the Member States where the device is made available.

Marking and labelling

Article 20 requires the CE marking; the four-digit Notified Body identification number appears next to the mark for all devices except Class I (non-sterile, non-measuring, non-reusable). Beyond the CE mark, the label must include (Annex I, Section 23):

• Device name and intended purpose;
• Manufacturer's details, including SRN;
• 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. As of May 2026, the Actor and UDI/Device modules are mandatory; the remaining modules are operating on a voluntary basis pending the Commission's publication of the EUDAMED full functionality notice.

Person Responsible for Regulatory Compliance (PRRC)

Article 15 requires each manufacturer (and each Authorised Representative, by Article 11) 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 (9 July 2024) — introduced gradual rollout of EUDAMED's mandatory use module by module; required manufacturers to give notice when ceasing supply of an essential device.
• Common specifications under Article 9 — adopted for products without intended medical purpose in Annex XVI (Regulation (EU) 2022/2346) and for class D in vitro diagnostic devices.
• The Commission has indicated that targeted MDR reform may be proposed in 2026 to address capacity constraints, fees, and innovation pathway concerns.

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(2)(a) of the EMC Directive; EMC requirements are within Annex I of the MDR).
• Council Directive 85/374/EEC on liability for defective products.

Common errors

• Continuing to place devices on the market under MDD certificates without meeting Regulation 2023/607 conditions. Legacy certificate extension is conditional on no significant changes to design or intended purpose and on the manufacturer having lodged a formal application with an MDR-designated Notified Body by 26 May 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 a predicate device is now subject to strict conditions in Article 61(5) — access to the predicate's technical documentation, similar characteristics, and a contract giving the manufacturer continuous access to the 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.

Sources

• Regulation (EU) 2017/745 (MDR) — EUR-Lex consolidated text.
• Regulation (EU) 2023/607 (transitional extension) — EUR-Lex.
• European Commission — Medical devices sector (DG SANTE).
• European Commission — EUDAMED.
• Medical Device Coordination Group (MDCG) guidance documents — DG SANTE.