EU Medical Device Classification & Regulation (MDR/IVDR)

Medical devices placed on the market in the European Union (EU) are regulated by the European Commission (EC) and competent authorities of EU Member States. The primary legislations are Regulation (EU) 2017/745 on medical devices (EU MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EU IVDR), which replaced the earlier Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD), and In Vitro Diagnostic Directive (IVDD).

Devices must comply with the applicable EU regulatory requirements and bear the CE mark before being placed on the EU market. Manufacturers must also register their devices and relevant economic operators in the European database for medical devices (EUDAMED).

Manufacturers not based in the EU must appoint a European Authorised Representative (EU AR). The EU AR acts on behalf of the manufacturer ensuring regulatory compliance is upheld for the devices they represent in the European market, including maintaining a copy of the technical documentation, Declarations of Conformity, and acting as a liaison between the Manufacturer and the EU competent authorities.

European Union medical device and IVD classification

Medical devices are classified as Class I self-certified, Class I sterile, Class I measuring, Class I reusable, Class IIa, Class IIb, and Class III under the EU MDR. IVDs are classified as Class A self-certified, Class A sterile, Class B, Class C, and Class D under the EU IVDR. Classification determines the conformity assessment route and the level of Notified Body involvement required.

EU medical device regulatory pathways

There is one principal route to market for the EU: CE marking under the applicable EU regulation. The specific conformity assessment procedure and route depends on the nature, intended purpose, and applicable classification of the device.

CE Marking under EU MDR (Regulation (EU) 2017/745)

• Process: The manufacturer completes a conformity assessment in accordance with the EU MDR, involving an EU Notified Body, as applicable, based on the device classification. Notified Bodies are required for medical devices classified as Class Is, Class Im, Class Ir, Class IIa, Class IIb and Class III. Upon successful assessment, the manufacturer finalizes the EU Declaration of Conformity, affixes the CE mark, and registers the device and relevant economic operators in EUDAMED.

• Requirements: Documentation includes a technical documentation file demonstrating conformity with the General Safety and Performance Requirements (GSPRs), an EU Declaration of Conformity, evidence of a quality management system in compliance with EU MDR Art 10(9), clinical evaluation documentation, Post-Market Clinical Follow-up (PMCF) planning, and labeling. ISO 13485 certification is not mandatory but highly recommended.

• Timeline: Review timelines depend on the applicable device classification and Notified Body availability. Manufacturers should expect certification timelines of 12–24 months, or more for higher-risk devices, when appointing renowned Notified Bodies. Shorter timelines are possible when appointing smaller-scale Notified Bodies.

• Renewal: EU MDR certificates issued by a Notified Body are typically valid for up to five years. EUDAMED registrations must be maintained and updated as required by the Manufacturer.

CE Marking under EU IVDR (Regulation (EU) 2017/746)

• Process: The manufacturer completes a conformity assessment in accordance with the EU IVDR, involving an EU Notified Body for Class A sterile, Class B, Class C, and Class D devices. Upon successful assessment, the manufacturer finalizes the EU Declaration of Conformity, affixes the CE mark, and registers its devices in EUDAMED.

• Requirements: Documentation includes a technical documentation file demonstrating conformity with the GSPRs of the EU IVDR, an EU Declaration of Conformity, evidence of a quality management system in compliance with EU IVDR Art 10(8), performance evaluation documentation, Post-Market Performance Follow-up (PMPF) planning, and labeling. ISO 13485 certification is not mandatory but highly recommended.

• Timeline: Notified Body capacity for IVDR assessments is limited. Manufacturers should plan for extended timelines, particularly for Class C and Class D devices. Shorter timelines are possible when appointing smaller-scale Notified Bodies.

• Renewal: EU IVDR certificates are typically valid for up to five years. EUDAMED registrations must be maintained on an ongoing basis by the Manufacturer.

Key EU registration requirements

• Authorised Representative: Required for manufacturers established outside the EU.

• Registration in EUDAMED: All Economic Operators (i.e., manufacturers, ARs, and importers) must be registered in EUDAMED as Actors. The Actor Registration requires the assignment of a Single Registration Number (SRN). The Manufacturer’s devices must be registered in EUDAMED before being placed on the EU market. It is important that the Manufacturer meets all UDI requirements, including assigning a Basic UDI-DI for each device family, prior to registering the devices in EUDAMED.

• Unique Device Identification (UDI): Manufacturers must assign all applicable UDIs to their devices and upload the UDI data to EUDAMED. Implementation deadlines vary by device classification and applicable EU Legislation, with EU MDR and EU IVDR compliant devices required to carry UDIs first.

• Labeling: Labeling must be in the official language(s) of the Member State(s) in which the device is made available. Symbols used on labels must comply with applicable harmonized standards.

• Post-market obligations: Manufacturers must establish a post-market surveillance (PMS) system proportionate to the risk class of the device. For Class IIa, IIb, and III devices under the EU MDR, and Class B, C, and D devices under the EU IVDR, manufacturers must prepare Periodic Safety Update Reports (PSURs) on a defined schedule. Manufacturers must report serious incidents and field safety corrective actions (FSCAs) to the relevant national competent authority via EUDAMED.

What documentation is required to register a medical device or IVD in the EU?

Documentation requirements depend on device classification and the selected conformity assessment procedure. In general, manufacturers should prepare:

• A complete technical documentation file demonstrating conformity with the General Safety and Performance Requirements of the EU MDR or EU IVDR, as applicable

• An EU Declaration of Conformity referencing the applicable EU regulation and listing the Notified Body identification number where applicable

• Quality management system in compliance with Art 10(9) MDR or Art 10(8) IVDR, as applicable.

• A clinical evaluation report (EU MDR) or performance evaluation report (EU IVDR), with supporting clinical or performance data and a corresponding post-market follow-up plan

• EU MDR or EU IVDR certificates from a designated EU Notified Body, where required by device classification

• UDI assignment and registration in EUDAMED, including Actor registration for the manufacturer and link to the appointed EU AR

• Post-market surveillance documentation, including a PMS plan and, for applicable device classes, a PSUR or PMS report

What is a European Authorised Representative and why do you need one?

An EU AR is a legal entity established in an EU Member State that acts on behalf of a manufacturer located outside of the EU. The EU AR ensures that the EU Declaration of Conformity and technical documentation have been drawn up, cooperates with competent authorities and manufacturers on post-market surveillance and vigilance activities, and maintains copies of technical documentation for inspection. Under the EU MDR and EU IVDR, the EU AR is explicitly identified on device labels and is held equally liable as the foreign Manufacturer. Non-EU manufacturers cannot place devices on the EU market without appointing an EU AR.

What is a Notified Body?

A Notified Body is an independent conformity assessment organization designated to carry out third-party assessments under the EU MDR or EU IVDR. Notified Bodies review quality management systems, technical documentation, and clinical or performance evidence for higher-risk devices before issuing EU certificates. Only NBs with an appropriate scope of designation can assess certain device types. The list of currently designated EU MDR and EU IVDR Notified Bodies is maintained in the NANDO (New Approach Notified and Designated Organisations) database. Manufacturers may select any Notified Body with the relevant designation, regardless of the EU Member State in which the Notified Body is established.

What are the transitional provisions and key deadlines under the EU MDR and EU IVDR?

The EU MDR and EU IVDR introduced transitional provisions to allow time for manufacturers, Notified Bodies, and the supply chain to adapt. These have been extended multiple times by the European Parliament and Council. The current key deadlines are:

EU MDR (Regulation (EU) 2017/745) transitional provisions as identified in Regulation (EU) 2023/607:

• Class III and Class IIb implantable devices (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors) with certificates issued under the MDD/AIMDD: may be placed on the market or put into service until 31 December 2027.

• Class IIa, Class IIb non-implantable, Class I measuring, and Class I sterile devices with certificates issued under the MDD may be placed on the market or put into service 31 December 2028.

• Class I self-certified devices under MDD who did not require the involvement of a notified body under the MDD, that require Notified Body involvement under EU MDR may be placed on the market or put into service 31 December 2028.

Devices must comply with all the requirements identified in Regulation (EU) 2023/607 to benefit from these transitional deadlines. The conditions are:

• The devices continue to comply with the MDD/AIMDD;

• There are no significant changes in the design and intended purpose of the devices;

• The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health;

• No later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9) of the MDR;

• The manufacturer has lodged a formal application with a notified body for the conformity assessment under the MDR no later than 26 May 2024 (for all classification devices);

• The notified body and the manufacturer have signed a written agreement for the conformity assessment under the MDR no later than 26 September 2024 (for all classification devices);

EU IVDR (Regulation (EU) 2017/746) transitional provisions as identified in Regulation (EU) 2024/1860:

• Class D IVDs that did not require the involvement of a notified body under the IVDD or have certificates issued under the IVDD as List A or List B may be placed on the market or put into service until 31 December 2027.

• Class C IVDs that did not require the involvement of a notified body under the IVDD or have certificates issued under the IVDD as List A or List B may be placed on the market or put into service until 31 December 2028.

• Class B IVDs and Class A sterile IVDs that did not require the involvement of a notified body under the IVDD may be placed on the market or put into service until 31 December 2029.

• Class A Self-certified IVDs must be already in compliance with EU IVDR as of 26 May 2025.

Devices must comply with all the requirements identified in Regulation (EU) 2024/1860 to benefit from transitional deadlines. The conditions are the following:

• The devices continue to comply with the IVDD;

• There are no significant changes in the design and intended purpose of the devices;

• The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health;

• No later than 26 May 2025, the manufacturer has put in place a quality management system in accordance with Article 10(8) of the IVDR;

• The manufacturer has lodged a formal application with a notified body for the conformity assessment under the IVDR no later than:

• (i) 26 May 2025, for devices classified as Class D under the IVDR;

• (ii), 26 May 2026, for devices classified as Class C under the IVDR;

• (iii), 26 May 2027, for devices classified as Class B or Class A sterile under the IVDR;

• The notified body and the manufacturer have signed a written agreement for the conformity assessment under the IVDR no later than:

• (i), 26 September 2025, for devices classified as Class D under the IVDR;

• (ii), 26 September 2026, for devices classified as Class C under the IVDR;

• (iii), 26 September 2027, for devices classified as Class B or Class A sterile under the IVDR.

Devices placed on the EU market after these transitional deadlines, or devices that do not meet all the conditions from Regulation (EU) 2024/1860 or Regulation (EU) 2023/607, must comply fully with the EU MDR or EU IVDR. Manufacturers should monitor EU legislative developments for further changes to deadlines and requirements.

What if my device was CE marked under the MDD or IVDD and I need to transition?

Manufacturers holding a MDD, AIMDD, or IVDD certificate must transition their legacy devices to EU MDR or EU IVDR conformity before the applicable transitional deadline and shall meet the transitional timelines requirements as per Regulation (EU) 2023/607 for Medical Devices or Regulation (EU) 2024/1860 for IVDs. The transition process involves a full conformity assessment under the new regulation, including updated technical documentation, a new clinical evaluation or performance evaluation under the updated requirements, and Notified Body certification where required. Manufacturers should engage their Notified Body early, as capacity is limited and timelines for initial certification under EU MDR and EU IVDR are typically long. EUDAMED registration under the new framework must also be completed as part of the transition. It is important to note that legacy devices will also require EUDAMED device registration by 27 November 2026.