Two scrutiny procedures
1. Control procedure (Scruting)
The new scrutiny procedure focuses on the regulatory oversight of the submitted clinical evaluation by the European Commission. For this purpose, the Notified Body will issue a CEAR for implantable Class III products or active Class IIb products that donate medicinal products to the body (but not for recertification or mere modifications), based inter alia on the clinical evaluation. The CEAR goes to the Medical Device Coordination Group (MDCG), a committee of experts of the European Commission, which decides within a maximum of 21 days whether or not a scientific opinion on the CEAR is presented by him.
If the former is correct, the panel must provide the scientific opinion on the CEAR within 60 days. The notified body must take into account the scientific opinion in its decision and if necessary. grant the certificate only with restrictions or conditions. If the opinion is not completed by the deadline, the notified body may continue the certification process without modification.
2. Consultation procedure
In this context, however, mention must also be made of the new consultation procedure which the Notified Bodies have for Class III implantable devices and class IIb active products intended to deliver to the body a medicinal product as defined in Section 6.4 of Annex VIII (Rule 12) and / or remove it from the body.
The Clinical Assessment Center Prof. Zenner and Partners can support the company with robust clinical documents in the two Scrutiny procedures.