EU: BSI Assurance UK is the first notified body in accordance with Regulation 2017/745

As the first notified body for the EU Regulation on Medical Devices, BSI Assurance UK has now been entered into the Nando database under Notified Body number NB 0086.

Its notification covers all areas of responsibility for the processes in accordance with Annexes IX and XI(A). Processes in accordance with Annexes X and XI(B) are restricted to active products for simulation or inhibition (MDA 0305), non-active contraceptives (MDN 1210) and gloves (MDN 1214 with corresponding restriction).
This notification does not apply to the independent BSI subsidiary in the Netherlands (NB 2797). No notified bodies have been recorded for the IVD regulation 2017/746 yet (update here).