Role and Significance of Notified Bodies under the New Medical Devices Regulation and the In Vitro Diagnostics Regulation

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Role and Significance of Notified Bodies under the New Medical Devices Regulation and the In Vitro Diagnostics Regulation

On 25 May 2017, the new Medical Devices Regulation and the In Vitro Diagnostics Regulation (IVDR) entered into force. The MDR and the IVDR both maintain the concept of conformity assessment procedures being performed by notified bodies, established for this purpose in each member state. However, both Regulations include extensive new provisions concerning the
proof of qualification of notified bodies, their supervision and the exercise of their activities. Wolfgang Rehmann of Taylor Wessing explains the MDR Regulation (EU) No. 2017/745 in this essay.

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