European Medical Device Regulation - Are you ready?

The editors of Medical Plastics News and Med-Tech Innovation News want to know if you are ready for the enforcement of these regulations.

From 26th May 2020 Medical Device Regulation (MDR) will come in to effect in EU Member States. This regulation applies to all manufacturers selling medical devices within Europe, and aims to provide greater protection of public health and safety. 

However, with the enforcement of this legislation rapidly approaching, the US are calling for these regulations to be delayed by three years. The US listed the main reasons for this to the World Trade Organisation recently, and these included confusion remaining around the designation of Notified Bodies (NBs); The European Commission (EC) previously predicted atleast 20 NBs and there is currently thought to be around 12. Additionally, the EC's draft standardisation was heavily criticised.

If you are a manufacturer of medical devices please could you take two minutes to complete our survey?

The survey will close on Monday 2nd September, and we hope to collate the results in to an infographic later this year.