HomeNewsScrutiny process: Procedure for the new medical devices regulation

Scrutiny process: Procedure for the new medical devices regulation

12/02/2019


Implantable devices of class III as well as the active devices of class IIb intended to administer/remove a drug in the body exemple (e.g. infusion pump) are involved in this process. 
 
 

This does not apply to devices that are subject to certificate renewal, modifications made to a device by the same manufacturer but also when there are common specifications

To be subject to the inspection procedure, the device file must be submitted to a notified body (NB).

 
 

This procedure consists of the evaluation of the technical documentation (by sampling or not according to the class of the device) and the quality of the clinical data to support the clinical evaluation report of these products.


The manufacturer's report and documentation are then submitted to a committee of experts from the European Commission (MDCG). The committee has at its disposal 21 days to inform the notified body via Eudamed its intention to provide scientific advice or not. The maximum response time is 60 jours. After this period, the notified body may initiate the certification procedure. 

  

If the notified body does not follow the opinion of the committee of experts, it must justify this in the conformity assessment report. The commission's opinion should also be made available to the public in Eudamed. 


 

 (source : Medtech Europe)


After consultation with the Committee of Experts, the NB may, depending on the decision taken:

  • Reduce the target population using medical devices
  • Limit the period of validity of the certificate
  • Encourage the manufacturer to set up a study PMCF
  • Adapt the manual

 

The evaluation by a committee of experts of specific medical devices will generate in the long term guidelines and thus obtain a congruence the procedure for evaluating the most at-risk ranges of medical devices. 

 
 
 
 
  

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