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).

For the standard commercial conformity route, devices must meet the applicable requirements and bear the CE mark before placement. Custom-made devices, investigations, in-house devices and other special cases have their own provisions. Manufacturers must also complete applicable actor and device registration in the European database for medical devices (EUDAMED), applying the actual scope and deadlines.

Manufacturers established outside the applicable Union territory must appoint a European Authorised Representative (EU AR). Assess this against the EU/EEA framework and applicable treaty arrangements, rather than treating every address outside an EU Member State identically. 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. Obtain a device-specific schedule covering readiness, application review, assessment, questions and closure; the size or reputation of the Notified Body is not a reliable guarantee of speed.

• 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: Plan around the relevant Notified Body scope and capacity, dossier readiness and assessment route. Confirm the actual schedule and question-response process rather than inferring a shorter review from a smaller provider.

• 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 applicable Union territory; account for EEA and applicable treaty arrangements.

• Registration in EUDAMED: Applicable actor roles include manufacturers, ARs, importers and system/procedure-pack producers; ordinary distributors are not automatically registered as those actors. The Actor Registration requires the assignment of a Single Registration Number (SRN). Apply the specific EUDAMED device scope and timing, including the transition for relevant devices already placed before mandatory use and exceptions such as custom-made devices. 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. Under MDR, Classes IIa, IIb and III require PSURs; Class I uses a PMS report. Under IVDR, Classes C and D require PSURs, while Classes A and B use a PMS report. Apply the relevant update and submission rules for the device. Manufacturers must report serious incidents and field safety corrective actions through the currently applicable competent-authority arrangements; mandatory use of four EUDAMED modules does not yet make the vigilance module mandatory.

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 an eligible natural or legal person established within the applicable Union territory who accepts a written mandate from a manufacturer established outside that territory. The framework extends through the EEA and applicable treaty arrangements; confirm the operator location and competent authority. 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. The representative is identified in the applicable product information. Article 11(5) provides conditional joint and several liability for defective devices when the non-EU manufacturer has failed to comply with Article 10; it does not transfer all manufacturer duties to the representative. Manufacturers subject to the Article 11 representation requirement must complete that appointment before placement.

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?

Transitions apply to eligible legacy devices, subject to continuing conditions. A final end date is not an extension for a new device, a significant design/intended-purpose change or a portfolio that missed an earlier application milestone.

MDR legacy routes: Regulation (EU) 2023/607 provides the following conditional end dates:

• 31 December 2027: Class III and Class IIb implantable devices, except the specified well-established implantables.
• 31 December 2028: Other Class IIb devices, Class IIa, Class I sterile/measuring, and eligible formerly self-declared MDD devices that newly need a Notified Body under MDR. The excepted Class IIb implantables include sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

Eligibility includes continued directive compliance, no significant design or intended-purpose change, no unacceptable risk, an MDR QMS and formal application by 26 May 2024, and a written Notified Body agreement by 26 September 2024. Check certificate validity and appropriate surveillance, including the additional conditions for certificates that expired before the amendment. The separate derogation for Class III custom-made implantables ended on 26 May 2026.

IVDR legacy routes: Distinguish devices covered by an IVDD certificate from formerly self-declared devices newly requiring Notified Body involvement. Under Regulation (EU) 2024/1860:

The IVDR QMS milestone was 26 May 2025. Continued directive conformity, no significant changes and no unacceptable risk are also conditions. Qualifying certificate validity and withdrawal status matter, with additional conditions where a certificate expired before 9 July 2024. Do not give an IVDD-certified Class C device the later self-declared Class C deadline merely from its new risk class. Non-sterile Class A and new devices do not receive this legacy extension.

Use the Commission's IVDR transition Q&A to assess documentary eligibility. Final placement dates concern the relevant units first placed on the market; distinguish those from devices already lawfully placed in the supply chain. The former regulatory sell-off deadline was removed.

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. Relevant legacy devices continuing to be placed can fall within the EUDAMED registration deadline of 28 November 2026; assess the specific device scope and exceptions in the registration guide.

October 2026 portfolio review priorities

Confirm whether your device follows MDR, IVDR or an eligible legacy route. The IVDR Class C application and written-agreement milestones in May and September 2026 have now passed; verify eligibility with dated records. Final legacy end dates do not restore a missed condition.

Review EUDAMED for the applicable November 28, 2026 device-registration case, and avoid treating a forecast for a remaining module as a binding reporting date. Connect the GSPR evidence map, clinical/performance evaluation and PSUR/PMS Report so conclusions remain consistent.

Use the Commission transition guidance and current guidance index alongside the legal text. Government registration, Notified Body assessment, test generation and professional support are different cost components; obtain a device-specific quote and calendar rather than presenting one universal EU fee or review duration.