SECOND Notified Body under the MDR

The EU Commission Website now also includes a second Notified Body under the 2017/745:

  • TÜV SÜD Product Service Gmbh Zertifizierstellen

TÜV Süd is qualified for the following Conformity assessment procedures:

 

  • Annex X:      Conformity assessment based on type examination
  • Annex IX(I):  Conformity assessment based on a quality management system
  • Annex IX(II): Conformity assessment based on assessment of technical documentation
  • Annex XI(A): Conformity assessment based on product quality assurance
  • Annex XI(B): Conformity assessment based on product conformity verification

and various types of medical device / active implantable medical device, Details see Notification

 

The first Notified Body published under the (EU)2017/745 was

  • BSI Assurance UK LTD, in Milton Keynes

see also our news blog under  "First MDR Notified Body".

 

 

BSI Assurance UK Ltd. does not provide all of the possible Conformity Assessment Procedures as TÜV SÜD Product Service see Notification of BSI UK.