As you may be aware from our previous blog post, the European Union published the new Medical Device Regulation (MDR) on May 5th, 2017 and it is expected to be enforced starting May 25th, 2020. This new regulation repeals the Medical Device Directive (MDD) and Active Implantable Medical Device Directive.
Since last year, the European Commission (EC) has released many guidance documents for several different types of medical devices and the European Database on Medical Devices (EUDAMED) has been updated with new information. A new EUDAMED will be released in 2020.
Last month, a new Implementing Decision was published, the COMMISSION IMPLEMENTING DECISION (EU) 2019/939 that designates entities to assign Unique Device Identifiers (UDIs). Currently only 4 designated entities are listed in the Annex and concerns may arise about the capacity of these entities to issue UDIs without any delays.
Finally, only two notified bodies (BSI and TÜV Süd) have been designated against the MDR so far and none have yet been assigned against the IVDR. It remains to be seen whether the EC’s goal of assigning 20 notified bodies will be achieved by the end of this year, so delays in patient access to medical devices can be prevented.