We now have seven Notified Bodies designated under Regulation (EU) 2017/745 on medical devices, the newest of which is BSI Netherlands,  NB2797.

Whilst this is obviously a step in the right direction, we are still nowhere near the number required to manage an effective transition to the new Regulation in May 2020. There are currently 55 NBs designated under 93/42/EEC, some of which  may choose not to make the transition at all. One wonders where this will leave the industry come May, and whether the Commission will need to make some concessions to allow companies to continue to trade.

Watch this space for more news…