This template applies to MDR Annexes IX section 4 and Annex X section 3. It also applies to assessments of technical documentations on a sampling basis for class IIa/IIb devices in accordance with Annex IX sections 2.3 and 3.5 and Section 10 of Annex XI(A).
Aspects related to the clinical evaluation assessment are also laid down in Section 4.5.5 and other relevant sections of Annex VII. It also applies to medical devices for which clinical data is not deemed appropriate to demonstrate conformity with Annex I, and the demonstration of an adequate justification for this
Clinical evaluation assessment report template .July 2020