EU Parliament adopts new Medical Device and IVD Regulations

The EU Parliament has adopted the proposal for the Medical Device Regulation, which will replace the current Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC), and the IVD Regulation, which will replace the current IVD Directive (98/79/EC). 

You can find more information on our dedicated revisions webpages:

MDR Revision

IVDR Revision


EU Referendum Result (BREXIT)

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.

BSI to open a Notified Body in the Netherlands

BSI America can help your medical device organization

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