Notified Bodies update: NB designation to the new Regulations

Posted on 05.06.2018

To date we still find ourselves in a situation where no Notified Body (NB) has been designated under the IVDR and/or MDR. However, MedTech Europe understands that out of the 20-30 NBs that have applied for designation since November 2017, three already underwent the on-site assessment by the joint assessment team and three others have confirmed dates later on this year. This could potentially indicate that some NBs may be designated earlier than July 2019 as initially estimated in NBOG’s Best Practice Guide