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TUV Sued is second Notified Body after MDR

CE Mark is awarded by Notified Body
photo: IStock
CE Mark is awarded by Notified Body

16.06.2019 – TUV Sued Product Service has been recognised by the “Central Office of the Countries for Health Protection with regard to Pharmaceuticals and Medical Devices” (ZLG) as the second Notified Body for the new Medical Devices Regulations (MDR) after the British-Dutch BSI.

Notified Bodies must be designated by a state supervisory authority and notified by the EU Commission. Only 39 of the current 58 Notified Bodies have applied for a new designation for the MDR. Of these 39 applicants, 23 have so far been audited. TUV Sued and BSI are the only ones recognized for the MDR to date. More information

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