We understand the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to global markets. Ensuring the predictability and transparency of regulatory product clearance is key to maintaining a competitive edge.

The final texts of the new European Medical Devices Regulation (MDR) and IVD Regulation (IVDR) have been published in the Official Journal of the European Union. Entry into force will commence on May 26th, 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. The IVDR, which replaces the IVD Directive (98/79/EC), has a transition period of five years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

You can find more information on our dedicated revisions webpages:

MDR Revision

IVDR Revision

After Britain voted to leave the EU, BSI will continue to operate as an EU Notified Body.

Read our full statement to understand more about BSI's position.