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EU MDR Explained

To import medical devices into the EU, manufacturers are required to comply with EU MDR. Here’s what you need to know about EU MDR.

What is the EU MDR?

The European Union Medical Device Regulation (EU MDR) lays down standards for medical devices marketed in the EU. It replaces the Medical Devices Directive (MDD) and mandates testing, clinical evaluation, and post-market surveillance.

By harmonising regulations across EU member states, the EU MDR aims to maintain a high level of protection for users while also streamlining market access for manufacturers. EU MDR includes a new database for medical devices – the EUDAMED which supports the regulator’s oversight of medical devices on the market.

Who needs to comply with EU MDR?

All manufacturers marketing medical devices within the European Union must adhere to the EU MDR. From simple bandages to advanced implantable devices, if it is a medical device then EU MDR applies.

May 26 2024

Deadline for compliance with EUMDR. After this date, non-compliant devices cannot be legally sold within the EU.

How to prepare for the deadline

1. Appoint a EU MDR Expert

Assign a trusted partner to guide you to compliance with EU MDR.

2. Plan for Audits

Prepare for inspections and compliance checks by the regulatory body.

3. Update PMS Activities

Improve Post-Market Surveillance to meet EUMDR requirements.

4. Update Device Documentation

Review and update technical files and Unique Device Identification (UDI) for compliance.

5. Select a Suitable Notified Body

Choose a notified body for EUDAMED.

Act now

Manufacturers should undertake a gap analysis to identify what they need to do in time for the May 26th deadline.

Contact us

Contact us for guidance and support in navigating the complexities of EUMDR.

Key Components of EU MDR

A) Roles and Responsibilities

  • Ensuring compliance: review technical documentation
  • Monitoring: Post-market surveillance
  • Acting as liaison: Communicating with Competent Authorities and coordinating with manufacturers

B) Regulatory Requirements

  • Medical Device Regulation (MDR)
  • In vitro Diagnostic Regulation (IVDR)
  • Quality Management System: ISO 13485 Certification and Risk Management

Do you sell medical devices in the UK? Medical Devices manufacturers require a UK Authorised Representative to sell in the UK.

C) Documentation Management

  • Maintaining records including technical files and Declaration of Conformity
  • Updating documentation: Labelling and instructions for use & Post-market surveillance reports

D) Communication and Reporting

  • Incident Reporting: Adverse Event Management & corrective actions
  • Authority Notifications: Reporting changes to authorities & notifying serious incidents

E) Product Registration

  • CE Marking (UKCA Marking for UK medical devices not yet in effect)
  • EUDAMED Database: Registration and data submission