EU joint Market Surveillance Project 2014 - 2020

(June 19, 2015)

The European Commission (EC) has market surveillance on its list of priorities. The Competent Authorities for Medical Devices (CAMD) group recognizes that there is a lot of merit in member states (MS) working together on market surveillance.

Advantages of collaborative working are

  • the power of rolling out programmes simultaneously in several MS.
  • resources to deliver all market surveillance are fairly constrained so sharing and pooling resources makes senses

The EC allocated euro 202K. for a small market surveillance project undertaken by a group of MS in the context of the second phase of the commission's joint action plan. This project will involve a review of the quality of instructions for use (IFU), particularly in Class I medical devices,. The aim is to roll out the programme in several MS simultaneously.

We already know the funding of abovementioned project was successful and run for a much larger market surveillance project is in initiated at this moment. A budget of euro 1.0 mio is appointed to build an adequate infrastructure, develop software that helps the system function (Prosafe, medtech market surveillance software), and to train people across the system.

Prosafe aims to:
  • ensure an effective level of formal networking with various international bodies as well as organizations within and outside EU;
  • continue to provide a practical forum for exchanging information through various means, including PROSAFE meetings, discussions and networking between all respective members whilst employing a maximum of discretion;
  • strive to act as an initial platform for certain European projects, building up the necessary initial infrastructure and informal feedback on certain issues that require a focus approach; and
  • take steps to establish a system of voluntary mutual peer review or its members with the goal of achieving a higher level of product safety within the EU.

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