New Medical Devices Regulation now published

The final text of the new European Medical Devices Regulation (MDR) has been published in the Official Journal of the European Union. The Regulation entered into force on May 25th, marking the start of the transition period for manufacturers selling medical devices into Europe.



The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.

See the latest information from the EU Commission here

The start of this long process of change occurred on 26 September 2012, when the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, which replaces the existing three Medical Device Directives.  

Where can I find further information?

This transition page will be updated regularly with the latest facts. BSI will run a series of webinars and white papers to ensure we share valuable information with you regarding these significant changes.

The official non-BSI websites can also provide additional background and detailed information:

European Commission

Competent authority, MHRA

The final EU Commission text can be found here

Read the final text

If you have questions regarding the changes please contact your BSI Scheme Manager for initial questions.

Informative BSI white papers

MDR Safety and Performance Requirements white paper

The Safety and Performance Requirements (SPRs) of the Medical Devices Regulation (MDR) replace the previous Directives' Essential Requirements (ERs) and outline the key areas to address within the Technical Documentation. Our new complimentary white paper provides comparison of the SPRs and ERs, allowing you to understand what's changing in more detail. 

Download your copy today.

 

 

See our other titles:

Technical Documentation and Medical Devices Regulation
The European Medical Devices Regulations - What are the requirements for vigilance reporting and post-market surveillance?
Planning for implementation of the European Union Medical Device Regulations - Are you prepared?
How to prepare for and implement the upcoming MDR - Dos and Don'ts
The proposed EU regulations for medical and in vitro diagnostic devices