Notified Bodies bottleneck

It was already clear back in May 2017 that the appointment of Notified Bodies pursuant to MDR 2017/745 would cause a bottleneck. At the moment, merely four Notified Bodies have been appointed (compared to 57 previously) – one of which is in the UK. All certificates for higher class medical devices, if possible, should therefore be renewed again under the old guideline so as to be able to profit from the four additional years this interim solution offers. The Declarations of Conformity for class I devices need to be ready by the 26^th of May 2020. It will become critical for products, which will be moved from class I to a higher class through the new MDR and which, as a result, will need to be reassessed by a Notified Body. A number of substance-based medical devices (e.g. creams or throat sprays/tablets) are affected by new rule 21!