6. Unknown new Scrutiny method

The new Scrutiny-procedure

Das neue Scrutiny-Verfahren

The Scrutiny process consists of two sub-procedures: Scrutinization and Consultation.

The new scrutiny procedure is a more stringent clinical evaluation control procedure for some of the Class III implantable products and the active Class IIb products, respectively. The CEA Report of the Notified Body, which is based inter alia on the clinical evaluation, goes to the Medical Device Coordination Group (MDCG) of the European Commission for review and possible scientific opinion. The notified body must take into account a possible scientific opinion in its decision and, if necessary,. grant the certificate only with restrictions or conditions. But the consultation process has more to tell...