Section B — Reviewers involved in the notified body assessment
Source: MDCG-2020-01.pdf page 7 (document: MDCG 2020-13)
Section B: Reviewers involved in the notified body assessment of the clinical evaluation
Provide the name or the employee code of the personnel with relevant clinical expertise (as per 3.2.4 of annex VII):
_____
Relevant clinical expertise:
_____
Have additional reviewers been involved?
- Yes
- No
Provide a justification:
_____
Additional reviewers assigned to review the clinical evaluation
| Number of additional reviewers / Names of additional reviewers | Specific aspects assessed (by each additional reviewer) | Competence area / codes |
|---|---|---|
| Number of additional reviewers Names of additional reviewers: Separate the internal and external clinical reviewers. You may use employee codes | For example, rationale for the design and chosen statistical methodology of clinical investigation etc. | List of relevant MDR codes or area this person is authorised to, according to the Authorisation Matrix, as of Annex VII, 3.3.2) Relevant expertise: |