Many important documents and guidance for the implementation of Regulation (EU) 2017/745 on medical devices (MDR) are still missing. In certain aspects, however, things seem to evolve in a direction that could take some pressure especially from Notified Bodies.
Four Notified Bodies designated under the MDR
Recently, two more Notified Bodies have been designated under the MDR. In addition to bsi and TÜV Süd, the NANDO database now also includes DEKRA from Germany and IMQ from Italy. Still, this is only a very low number considered that only a few months are left until the MDR fully applies and that no Notified Body has been designated under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) yet. The latter point is currently considered a much bigger problem than the low number of MDR Notified Bodies.
Some relief for certain types of products?
Against this background, there has been a first statement by the European Commission that they would support initiatives that would exempt further device groups from the deadline of May 26, 2020. The most prominent group of devices would be class I reusable surgical instruments. It seems as if reusable surgical instruments and potentially other devices may make use of the extended deadline until 2024, which is (up to now) only applicable for class Im/s, IIa, IIb and III devices.
However, for the time being, there is no official decision at hand. This leaves manufacturers with the question if they should plan with caution and stick to what is currently required in the MDR or should they rely on the statement above.
Source: Medtech Insight (an Informa product)