The Action Plan for Immediate Actions under Existing Medical Devices Legislation 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).
On 20 June 2014, the Employment, Social Policy, Health and Consumers Affairs Council (EPSCO) 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(Summary of 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.
Joint assessments of notified bodies
1. Joint assessments under Regulation (EU) No 920/2013, between December 2013 and January 2017
This 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 European 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.
2. Voluntary joint assessments between January 2013 and November 2014
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.
- Commission reply to a petition 'For a compensation fund for PIP breast implants and CE' from change.org
- Commission Recommendation on a common framework for a unique device identification system of medical devices in the Union
- Commission Implementing Regulation (EU) No 920/2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices
- Commission Recommendation on the audits and assessments performed by notified bodies in the field of medical devices