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Class 3 Medical Device
Class 3 Medical Device constitutes high-risk devices such as Pacemakers, Brain spatula, Copper-T IUDs, Cardiovascular sutures, etc. Permanent monitoring is required throughout its lifetime. For Class 3, the declaration of conformity is backed up by notified body assessment followed by expert panel consultation and sometimes clinical evaluation consultation based on the type of device.
Implantable Class 3 Medical Device & CE Conformity Assessment Route
For high risk implantable Class 3 medical device (including devices with medicinal substances, human tissue or animal tissue derivatives with TSE risk, Class 3 Rule 21 devices), the CE mark conformity assessment route is as follows:
- Consultation (2001/83/EC, EC/726/2004, 2004/23/EC, EU/722/2012)
- Clinical evaluation consultation Procedure as per Annex IX sec. 5/Annex X sec. 6
- Declaration of conformity as per Annex IV
- Affixing the CE mark as per Annex V CE marking
Non-Implantable Class 3 Medical Device and CE Conformity Assessment Route
For Non-Implantable Class 3 medical device (including devices with medicinal substances, human tissue or animal tissue derivatives with TSE risk, class III Rule 21 devices), the CE mark conformity assessment route is as follows:
- Consultation (2001/83/EC, EC/726/2004, 2004/23/EC, EU/722/2012)
- Declaration of Conformity as per Annex IV
- Affixing the CE mark as per Annex V CE marking
Class 3 medical device Consultants
It is compulsory to have experts on board who have previous experience with Class 3 medical device, EU compliance and Clinical Evaluation for a successful outcome! Roles of I3CGLOBAL are as follows:
- Technical Documentation guidance & preparation
- Notified Body Submission and answering to the review comments
- Guides in Biological Evaluation
- Reviews the external protocols and reports
- Prepares Clinical Evaluation Report as per Meddev 2.7/1 Rev 4
- Conducts Risk Analysis and prepares Risk Management File as per EN ISO 14971
- Arranges Notified Body and coordinates with them till the issue of CE Certificate
- Arranges EU Representative from the European Union
- Arranges Free Sale Certificate from the European Union
- Develops Post Market Surveillance (PMS) plan, Post Market Clinical Follow Up (PMCF) plan and report and Periodic Safety Update Report (PSUR).
For detailed information about Class 3 Medical Device, specific sections refer to the below pages.