Class IIa Medical Device
Class IIa Medical Device constitutes medium-risk devices such as orthodontic wires, surgical gloves, lancets, etc. For class IIa Medical Devices, the declaration of conformity is backed up by notified body assessment.
Class IIa Medical Device CE Marking Conformity Assessment Route
For Class IIa Medical Device, CE Marking Conformity Assessment Route is as follows:
- Declaration of Conformity as per Annex IV
- Affixing the CE mark as per Annex V
Consultants' role in Class IIa Medical Device CE Marking
- Guidance and Technical File preparation
- Identifies test requirements and reviews the external reports
- Prepares Clinical Evaluation report as per Meddev 2.7/1 Rev 4.
- Prepares PSUR report
- Arranges Notified Body and coordinates with them till the issue of CE Certificate
- Arranges EU Representative from European Union
- Arranges Free Sale Certificate from European Union