Regulation

Medical Device Regulation (2017/745)

Regulation (EU) 2017/745 — the Medical Device Regulation or MDR — governs the placing on the EU market of medical devices. It defines what a device is, classifies devices by risk, sets conformity-assessment routes, and provides for the CE mark, EUDAMED and the Unique Device Identifier.

The instrument

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices is a directly applicable EU regulation. It became applicable on 26 May 2021, with transitional provisions extending the validity of certain prior certificates issued under Directive 93/42/EEC (the Medical Device Directive, MDD). Together with Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR), it forms the modern EU framework for medical-device regulation.

The MDR substantially tightened the rules previously found in the MDD: it introduced stricter clinical-evidence requirements, expanded the role of notified bodies, established a centralised EU database (EUDAMED) and a Unique Device Identifier system, and reclassified several categories of device into higher risk classes.

Definition of a medical device

Article 2(1) defines a "medical device" as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; providing information by means of in-vitro examination of specimens derived from the human body — including organ, blood and tissue donations.

The principal mode of action of a medical device must not be pharmacological, immunological or metabolic, although it may be assisted by such means. This is the legal boundary between a device and a medicinal product. A wound dressing acts physically; a topical antibiotic acts pharmacologically; the first is a device, the second a medicine.

Annex XVI of the MDR extends the device regime to certain groups of products without an intended medical purpose, including some cosmetic-adjacent products (for example, certain coloured contact lenses and equipment for the reduction or removal of subcutaneous adipose tissue).

Risk-based classification

Devices are placed in one of four classes by reference to Annex VIII classification rules:

• Class I — low-risk devices (for example, non-invasive bandages, spectacle frames). Generally self-certified by the manufacturer, with notified-body involvement only for sterile, measuring or reusable surgical instrument sub-categories.
• Class IIa — medium-risk devices (for example, hearing aids, certain dental materials). Notified-body involvement required.
• Class IIb — higher medium-risk devices (for example, surgical lasers, ventilators). Notified-body involvement required, with more demanding conformity assessment.
• Class III — high-risk devices (for example, implants for the spine, heart valves, breast implants). Subject to the most demanding conformity-assessment route.

Most devices commonly sold in parapharmacies are Class I or Class IIa: plasters and adhesive dressings, simple wound dressings, digital thermometers, saline nasal sprays, certain orthopaedic supports, compression hosiery in the lower classes, and similar items.

CE marking and notified bodies

To be placed on the EU market, a medical device must bear the CE mark, indicating that the manufacturer has carried out the conformity-assessment procedure appropriate to the device's class and that the device meets the General Safety and Performance Requirements set out in Annex I of the MDR. For Class I devices, the manufacturer may self-certify (with sub-class exceptions noted above); for Classes IIa, IIb and III, the involvement of a notified body is required.

A notified body is a conformity-assessment body designated by a Member State and operating under EU rules. The MDR substantially raised the bar for the designation, expertise and oversight of notified bodies, with the consequence that the number of designated bodies fell during the transition period. Lists of designated notified bodies are maintained in the NANDO database operated by the European Commission.

EUDAMED and UDI

The MDR establishes EUDAMED, a European database of medical devices, with modules covering actor registration, UDI/device registration, notified bodies and certificates, clinical investigations, vigilance and post-market surveillance, and market surveillance. EUDAMED is intended to be a single point of reference for regulatory information on devices placed on the EU market. Roll-out of modules has been phased; some modules have become mandatory while others have transitional arrangements.

Each device must carry a Unique Device Identifier (UDI), which has two parts: a device identifier (UDI-DI), specific to a device model, and a production identifier (UDI-PI), specific to a unit, batch, expiry date or serial number. The UDI is intended to support traceability, vigilance and post-market surveillance.

Economic operators

The MDR distinguishes manufacturers, authorised representatives (for non-EU manufacturers), importers and distributors, and sets specific obligations on each. Article 15 introduces a requirement that each manufacturer have a "person responsible for regulatory compliance" (PRRC) with the necessary expertise. Article 10 sets out general manufacturer obligations including risk management, post-market surveillance and reporting of serious incidents.

Distributors — including parapharmacy retailers — are subject to Article 14: they must verify, before making a device available, that the device bears the CE mark, that a declaration of conformity has been drawn up, that the device is accompanied by the information to be supplied by the manufacturer, and that, for imported devices, the importer has complied with Article 13.

Transition from the MDD

The transition from the MDD (Directive 93/42/EEC) to the MDR has been managed by transitional provisions in Article 120 of the MDR, extended by Regulation (EU) 2023/607 to give additional time for legacy devices to obtain MDR certification, subject to conditions. Specific transition dates vary by device class. Manufacturers and distributors are responsible for tracking the status of each device they handle. As a result, some devices on the EU market may still be CE-marked under the prior MDD certificates within the transitional regime; others have been re-certified under the MDR.

Last reviewed: May 2026.