So now we have 4 Notified Bodies designated under EU MDR. Unfortunately, one of these, BSI Assurance, is located in the UK, which is set to leave the EU on October 31st, so we’ll be back to 3. It is becoming increasingly unlikely that we will have a sufficient number properly designated by May 2020 to be able to certify all of the manufacturers currently holding an MDD CE certificate.

Have you spoken to your Notified Body? Do you know their plans for designation? Do they have a target date? Please do not leave this until the last minute. Start planning NOW for all eventualities, including a move to a new NB and all of the administrative headaches that will bring. If you need help with this, or with any aspect of medical device compliance over the coming months. get in touch and we can help.