Article 84: Post-market surveillance plan
Location:
Chapter VII, section 1
Source:
Eur-LexThe post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1 of Annex III. For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II.