The Next Big Wave

The need for a more developed and coordinated post-market surveillance structure for medical devices by Competent Authorities, as part of the joint action plan, is high on the Commission agenda.

This new market surveillance structure serves the purpose of increasing confidence in the medical devices sector after the 2011/2012 PIP breast implant scandal. The measures will have a big impact on the medical device industry in the EU.

It will also include a better organized vigilance system along with increased transparency.

The Competent Authorities Medical Devices (CAMD) have indicated that the market surveillance project encompasses the development of infrastructure to manage and execute collaborative market surveillance action.

Competent Authorities are challenged to reinforce their market surveillance, including appropriate checks on the characteristics of products by means of document review and, where appropriate, physical and laboratory tests on the basis of samples. When necessary and justified, it may also include a visit at the premises of economic operators to take samples.

Ton Pennings, CEpartner4U