Notified bodies: Where are we now?
As the EU Medical Device Regulation (MDR) deadline is rapidly approaching, our editor Laura Hughes takes a look at how many notified bodies have been successfully appointed ahead of the May deadline.
Have any notified bodies recently been approved?
On Friday 20th March, the 12th notified body was authorised for MDR work and listed in the NANDO database. The 12th notified body is the first from Hungary.
What is the latest news regarding notified bodies from the European Commission?
A presentation was posted by the Europen Commission on Wednesday 18th March disclosing that twelve notified bodies had been designated under MDR, three under In Vitro Diagnostic Regulation (IVDR), and another two notified bodies had received recommendations from the Medical Device Coordination Group.
Despite this news, the European Commission is still far from establishing the 20 notified bodies it originally hoped to have in place by the end of 2019, ahead of the EU MDR deadline in May this year.
How quickly can notified bodies be approved?
For notified bodies to be listed in the database it is a timely process where they need to go through at least five steps. The main reason for the lower than anticipated number of notified bodies is thought to be due to delays experienced within the current submission process.
Are lots of notified bodies waiting for approval?
There are a number of notified bodies which are said to be waiting for review. If these organisations are successful, then it would bring the total up to 23 notified bodies for EU MDR and five for IVDR. However, it is not known how long the approval process will take.
Will the date for implementing EU MDR be changed as a result of the coronavirus pandemic?
No. Currently the EU still plans to implement EU MDR on 26th May 2020.