The intensified market monitoring activities for medical devices across the EU as part of the EU’s PIP Action Plan have resulted in the fact that several conformity assessment bodies in Europe and Switzerland are no longer able to continue their activities in the field of certification of medical devices. This fact has consequences for manufacturers of medical devices.


The 55 Joint Assessments carried out so far (ie, international inspections of the conformity assessment bodies) have led to a reduction in the number of European and Swiss conformity assessment bodies from around 80 to under 60. In addition, the scope of the designations of conformity assessment bodies has also been partially restricted. This means that there are currently about 3,000 EC certificates without monitoring by conformity assessment bodies.

Many manufacturers have to find a new conformity assessment body that will certify their products. This process is not easy and can take up to one year. From a regulatory perspective, the validity of CE certificates in this transitional period has not been conclusively clarified. This raises the question of the further marketing of medical devices with relevant CE certificates for the first time.

A European procedure provides for a period of 12 months for the manufacturers to restore the regulatory requirements. However, prerequisites are that the regulatory requirements are all met, a known or recognized risk is not present, the manufacturer has demonstrably initiated a renewal of the certificate and the manufacturer can prove the status of the product.

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