Module 19 2021

24/05/2021

Annex XI – Production Quality Assurance

Annex IX Section 2.1 (QMS) applies in full and includes technical documentation required by Annex II and III for types approved Annex IX Section 2.2 a, b, d, and e apply (i.e. excludes section on design controls) Annex IX Section 2.3 audit requirements apply except for sampling

review of technical documentation Annex IX Section 2.4 applies in full

Annex IX Section 3 surveillance shall apply with the exception of sampling of technical documentation and design risk management Annex IX Section 4 does NOT apply (assessment of the technical documentation ) Verification of manufactured Class D devices required (batch release).

The Organisation for Professionals in Regulatory Affairs

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Manufacturer’s choice... Not all Notified Bodies will be designated for all Annexes. Check Nando listing to ensure your NB has been designated for your preferred choice of conformity assessment.

The Organisation for Professionals in Regulatory Affairs

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