How to Register a Medical Device in the European Union (EU): Step-by-Step Guide #

The European Union (EU) is one of the world's largest markets for medical technology. To ensure that only safe, effective, and high-quality devices reach patients, manufacturers must comply with the Medical Device Regulation (MDR, EU 2017/745) and the In Vitro Diagnostic Regulation (IVDR, EU 2017/746).

Unlike the U.S. FDA, the EU does not have a single central regulatory authority for medical devices. Instead, compliance is assessed through a multi-level framework involving manufacturers, Notified Bodies (NBs), and National Competent Authorities (NCAs) in each Member State.

This blog provides a step-by-step overview of the EU regulatory pathway for both general medical devices and in vitro diagnostic (IVD) devices.

1. Understand the Regulatory Bodies #

• There is no single central EU regulatory authority.
• Notified Bodies (NBs): Independent, EU-designated organizations that carry out conformity assessments for medium- and high-risk devices.
  Full list: EU Notified Bodies
• National Competent Authorities (NCAs): Regulatory agencies in each Member State responsible for market surveillance and enforcement.
  List: National Competent Authorities

2. Classify Your Device #

Device classification determines the regulatory pathway and level of scrutiny. Medical Devices (MDR - Annex VIII):

• Class I: Lowest risk
• Class IIa: Medium risk
• Class IIb: Medium-high risk
• Class III: Highest risk In Vitro Diagnostic Devices (IVDR - Annex VIII):
• Class A: Lowest risk
• Class B: Moderate risk
• Class C: High risk
• Class D: Highest risk

3. Choose the Correct Regulatory Pathway #

Conformity assessment procedures are risk-based:

EU MDR (Article 52):

• Annex IX: Quality management system (QMS) + technical documentation assessment (most common for higher-risk devices).
• Annex X: Type-examination (used often with Annex XI).
• Annex XI: Product conformity verification.

EU IVDR (Article 48):

• Annex IX, X, XI also apply, with adaptations for IVDs.

4. Implement a Quality Management System (QMS) #

A robust QMS is mandatory under both MDR and IVDR. It should cover the entire product lifecycle — from design and manufacturing to post-market monitoring. The framework most companies use is ISO 13485:2016, as it aligns closely with EU expectations.

MDR Article 10(9) and IVDR Article 10(8) require that the QMS is proportionate to device class and risk.

5. Compile Technical Documentation #

The Technical File (Annex II & III of MDR/IVDR) is the foundation for CE marking. It must be detailed enough for Competent Authorities or Notified Bodies to assess compliance.

Key contents include:

• Device description, variants, and intended purpose
• Design and manufacturing processes
• Risk management documentation
• Verification and validation reports (e.g., biocompatibility, software, sterilization)
• Clinical Evaluation Report (CER) or Performance Evaluation Report (PER)
• Labeling, packaging, IFU, and UDI information
• PMS and PMCF/PMPF plans

Keep the file up to date and searchable, as it will be reviewed during audits and regulatory inspections.

6. Appoint an Authorized Representative (AR) #

Non-EU manufacturers must appoint a single Authorized Representative (AR) located in the EU (MDR/IVDR Article 11). The AR's responsibilities include:

• Acting as the liaison with Competent Authorities
• Holding copies of the Technical Documentation and DoC
• Ensuring the manufacturer meets EU obligations
• Cooperating in vigilance and incident investigations The AR shares legal responsibility for compliance, so a formal written agreement is required.

7. Register in EUDAMED #

EUDAMED is the EU database for medical devices.
Manufacturers, ARs, and importers must:

• Register as an Actor to obtain a Single Registration Number (SRN)
• Upload device information, including Basic UDI-DI
• Update data when changes occur

Currently, actor and UDI/device registration modules are live; vigilance and surveillance modules are being rolled out.

8. Affix the CE Mark #

• Once conformity is demonstrated, issue an EU Declaration of Conformity (DoC) and affix the CE marking.
• For devices assessed by a Notified Body, the CE mark must include the NB's identification number.
• CE mark requirements: Minimum vertical dimension of 5 mm (exceptions for small devices).
• Legal references: Article 20 (MDR) and Article 18 (IVDR).

9. Conduct Post-Market Surveillance (PMS) #

Manufacturers must operate a PMS system proportional to the risk class.

• MDR Chapter VII (Articles 83-86) & Annex III
• IVDR Chapter VII (Articles 78-81) & Annex III

PMS includes:

• Post-Market Surveillance Reports (PMSR) for Class I devices
• Periodic Safety Update Reports (PSUR) for Class IIa, IIb, and III devices
• Post-Market Clinical Follow-up (PMCF) or Post-Market Performance Follow-up (PMPF)

10. Unique Device Identification (UDI) #

• UDI provides a harmonized identification system across the EU for device traceability and safety monitoring.
• Legal basis:
  1. MDR Articles 27-28, Annex VI (Part C).
  2. IVDR Articles 24-25, Annex VI (Part C).
• Application:
  1. UDI must appear on device labels, packaging, and in some cases directly on the device.
  2. Manufacturers must upload UDI data into the EUDAMED UDI/Device Registration module.

11. Guidance and Resources #

The European Commission provides ongoing guidance via the MDCG (Medical Device Coordination Group):👉 MDCG guidance documents

Conclusion #

• The EU regulatory pathway is risk-based and highly structured. To place a device on the EU market, manufacturers must:
• Identify applicable regulation (MDR or IVDR).
• Classify the device correctly.
• Establish a compliant QMS.
• Prepare robust technical documentation.
• Engage with Notified Bodies (if required).
• Register in EUDAMED and implement UDI.
• Affix the CE mark.
• Maintain PMS, vigilance, and continuous compliance.

By following these steps, manufacturers can ensure smooth CE marking and secure access to the European market.