Notified Bodies must comply with EU MDR 2017/745 and Annex VII Requirements to be Met by Notified Bodies with regard to their designation to include:
- Organization
- General requirements
- Quality Management
- Resource requirements
- Process requirements
Permanently Available
To meet the above requirements the Notified Body must have permanently available the relevant and sufficient administrative, technical and scientific personnel in accordance with Annex VII Requirements to be Met by Notified Bodies (3.1.1) and relevant clinical staff in accordance with Annex VII Requirements to be Met by Notified Bodies (3.2.4) and where possible to be fully employed by the Notified Body.
Final Certification of Conformity
Personnel referred to in Annex VII Requirements to be Met by Notified Bodies (3.2.3), persons responsible for determining qualification requirements and (3.2.7) persons responsible for the final certification of conformity shall be employed by the Notified Body and not external experts or subcontractors.
Notified Bodies will make available and submit as requested documentation to the Authority Responsible for Notified Bodies to allow it to conduct:
- Assessments
- Designations
- Notifications
- Monitoring
- Surveillance
Interpretation and Practical Application
To ensure a uniform application of the requirements as set out in Annex VII Requirements to be Met by Notified Bodies, the EU Commission may implement acts to resolve issues relative to interpretation and practical application.
All acts will be in accordance with the examination procedure noted in Article 114 Committee Procedure (3).