The final text of the Medical Device Regulation, which will replace the current Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC), is now undergoing legal-linguistic review. 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.
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, once adopted by the European Parliament and by the Council, replaces the existing three Medical Device Directives.
The original proposal documents can be found via the following pages.
The lastest EU Commission draft can be found here
When are the Medical Device Directives changing?
The Council has planned to approve the agreement at ministers' level in September 2016. Following their legal-linguistic review, the draft Regulation will be then adopted by the Parliament and the Council, probably in early 2017.
The new rules will apply 3 years after publication for medical devices.
Use our Frequently Asked Questions document to learn more about the transition and the changes to the requirements.
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:
Competent authority, MHRA
If you have questions regarding the changes please contact your BSI Scheme Manager for initial questions.