News about EU regulations on medical devices and in vitro diagnostics
At the beginning of February, NAKI – Germany’s National Working Group on the implementation of the EU’s new Regulation on medical devices (the MDR) and Regulation on in vitro diagnostic medical devices (the IVDR) – met in Bonn to discuss the progress of the work being carried out by the seven NAKI subgroups (SGs). Reports were given by the following SGs:
- SG 1 – Transitional provisions
- SG 2 – Notified bodies
- SG 3 – Manufacturer obligations
- SG 4 – Market surveillance
- SG 5a – Classification/Distinction
- SG 5b –Vigilance system
- SG 6 – Clinical evaluation/Clinical investigations
- SG 7 – Reprocessing
The outcomes from the subgroups’ work are published on the website of the German Federal Ministry of Health (BMG). For now, the work of SG 7 is complete. Meanwhile, the work of the other six subgroups is ongoing. The overall impression gained from the meeting is that all groups have been initially addressing specific problems relating to the MDR, as the transitional period for this Regulation’s implementation ends on 25 May 2020. Going forward, the focus will shift increasingly onto problem areas in the implementation of the IVDR, which will enter into force on 26 May 2022.
In 2018, the BMG will also focus on bringing national legislation in line with the two new EU regulations. It aims to have drafted a first legislative proposal by the end of 2018. Given that the two EU regulations will apply directly in all member states, national law is expected to change.
Following the meeting on 1 February 2018, the initial outcomes from the NAKI subgroups were published on the BMG website at the following link (in German): www.bundesgesundheitsministerium.de/naki