The European Commission and EU countries have taken joint action to tighten controls, provide a better guarantee for the safety of medical devices, and restore confidence as part of the Joint Plan for Immediate Actions under existing Medical Devices Legislation (the so-called 'PIP Action Plan').
The plan was launched in 2012 following the discovery of the fraudulent use of non-medical grade silicone in breast implants that were manufactured by the company 'Poly Implant Prothèse' (PIP).
The Action Plan aims to improve control on the basis of existing legislation. It focuses on 4 key areas:
On 20 June 2014, the Employment, Social Policy, Health and Consumers Affairs (EPSCO) Council discussed a Commission Staff Working Document. This document contained a detailed analysis of the implementation of the joint actions taken by the Commission and EU countries, within the scope of the PIP Action Plan.
The discussion resulted in an agreement to proceed with a second set of measures relating to problematic issues, identified in the Commission Staff Working Document. These include steps to improve market surveillance, the functioning of notified bodies, communication and transparency, and the sharing of good practices.
These measures are currently being implemented.
The overview report describes the outcome of the joint assessments of notified bodies designated under Directives 90/385/EEC, 93/42/EEC, and 98/79/EC. These assessments have been mandatory since the entry into force of Commission Implementing Regulation (EU) No 920/2013. The report concludes that joint assessments have been useful in harmonising the interpretation of designation criteria and clarifying expectations of notified body performance throughout the EU and beyond. Adoption of this assessment model has fostered cooperation between the Commission and designating authorities, and contributed to the smooth functioning of the medical device regulatory framework. This helps to ensure that only well-functioning, properly-resourced and appropriately-staffed notified bodies are authorised to conduct conformity assessment in the field of medical devices.
The Commission expects that with the recently published Medical Devices Regulation (EU) 2017/745 and it's in vitro counterpart, Regulation (EU) 2017/746, the progress already made in improving the performance of notified bodies and strengthening the EU regulatory system will continue.
The overview report describes the outcome of a series of 25 joint assessments of notified bodies carried out in 23 countries, within the framework of the joint plan for immediate actions. These assessments were a result of a voluntary agreement by EU countries and notified bodies. A number of measures have since been put in place to resolve the problems identified. The results of these assessments have also facilitated the implementation of the mandatory joint assessments under Commission Implementing Regulation (EU) No 920/2013.