Medical Device Regulatory Requirements in European Union

Regulatory Authority European Commission
Regulatory Authority Website Link Click Here
Device Classification I, IIa, IIb and III
Medical Device Regulations EUMDR-2017/745 | Click Here
IVD Classification A,B,C,D
In Vitro Diagnostics Regulations Regulation (EU) 2017/746 | Click Here
Device Classification Guidelines MDCG 2021-24 Guidance on classification of medical devices | Click Here
Registration Process Register EU login | Click Here
Registration Timeline For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product
Conformity Assessment Route
EU declaration of conformity in accordance with Article 19 and Annex IV for the device model covered by the conformity assessment procedure.
 
The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such devices. For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory.
| Click Here
Technical Documentation Format

 Annex II: Technical Documentation

1.   Device Description And Specification, Including Variants And Accessories

2.   Information To Be Supplied By The Manufacturer

3.   Design And Manufacturing Information

4.   General Safety And Performance Requirements

5.   Benefit-Risk Analysis And Risk Management

6.   Product Verification And Validation

Annex III: Technical Documentation on Post-Market Surveillance

| Click Here
Requirement of Authorized Representative Yes
Labeling Requirements

MDR - Language requirements for manufacturers

| Click Here
Clinical Trials Information

MDCG 2024-3: Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices

| Click Here
Software Guidance Document

MDCG 2023-4: Medical Device Software

| Click Here
Database EUDAMED | Click Here
Fees for Submission

Published fees on notified bodies websites for MDR (Table 1.) and IVDR (Table 2.)

| Click Here
Declaration of Conformity

As per Annex IV, The EU Declaration of Conformity must include:

  1. Manufacturer’s name, trade name or trademark, SRN (if issued), address, and authorised representative details (if applicable).

  2. A statement that the declaration is made under the sole responsibility of the manufacturer.

  3. Basic UDI-DI (as per Annex VI, Part C).

  4. Product name, trade name, code/catalogue number, or other clear identifiers (e.g., photo if needed), and intended purpose. Identification can also be via the Basic UDI-DI.

  5. Risk class of the device (as per Annex VIII).

  6. A statement confirming the device complies with the Regulation and other applicable EU legislation.

  7. Reference to any Common Specifications (CS) used.

  8. If applicable, notified body name and number, conformity assessment procedure, and certificate details.

  9. Any other relevant information (if applicable).

  10. Place and date of issue, name, position, and signature of the authorized person (on behalf of whom they signed).

| Click Here
Certificate of Free Sale

Chapter 5, Article 60 talks about Certificate of Free Sale

Purpose: Issued for export upon request by the manufacturer or authorised representative.

Issuing Authority: The Member State where the manufacturer or authorised representative is established.

Content of Certificate:

  • Confirms the CE-marked device can be marketed in the EU.
  • Includes Basic UDI-DI (from UDI database under Article 29).
  • If applicable, includes notified body certificate number (from Article 56 and Annex XII).

EU Commission Role: May create a standard model/template for the certificate, aligned with international practices, through implementing acts.

| Click Here
Post Market Surveillance

Refer to Chapter VII: Post-Market Surveillance, Vigilance and Market Surveillance; 

Section 1: Post-Market Surveillance;

Article 83: Post-Market Surveillance System of the Manufacturer

 

| Click Here
Reportable Incidents

Refer to Chapter VII, Section 2: Vigilance

Article 87: Reporting of serious incidents and field safety corrective actions

| Click Here
Adverse Event Reporting Timelines

  • 15 Days – For most serious incidents:
Adverse Event Reporting Form Download
Field Safety Corrective Action
Chapter VII, Section 2: Article 87 and 88
 
It shall be submitted through the electronic system referred to in Article 92
| Click Here
Contact Phone +32 2 299 11 11
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 31/Aug/2025

If you found this helpful, consider supporting by buying me a coffee ☕
Every little bit counts!