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What is a Class 2a Medical Device?
Class 2a Medical Device constitutes medium-risk devices such as orthodontic wires, surgical gloves, lancets, etc. For class iia medical device Medical Device the declaration of conformity is backed up by notified body assessment.
Class 2a Medical Device 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 2a Medical Device
It is a must to have experts on board who have previous experience with Class 2a EU compliance and Clinical Evaluation for a successful outcome! Roles of I3CGLOBAL are as follows:
Roles of I3CGLOBAL are as follows:
- 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