Brussels, 20 June 2014
Restoring confidence in medical devices. Action Plan after the PIP scandal tightened control in Europe
Today, the EPSCO Council has discussed the joint actions taken by the European Commission and the Member States to restore confidence following the scandal of defective breast implants produced by the French PIP company. These measures were included in the Joint Plan for Immediate Actions under the existing Medical Devices legislation (the so-called PIP Joint Action Plan) agreed in 2012 (See IP/12/119).
“Consumers are safer today than they were when the PIP scandal was discovered”, said Neven Mimica, Commissioner for Consumer Policy. “Thanks to close cooperation between Member States and the European Commission, today's rules on medical devices are better enforced. We succeeded in particular to tighten the control of notified bodies. Some key improvements, however, require a reinforced legal basis. This is why I called on the Member States to reach a political agreement before the end of this year in order to allow rapid adoption of this vital dossier.”
The PIP scandal made it clear that immediate improvements in the oversight of medical devices were needed. This is why the European Commission and Member States agreed on an Action Plan aiming at improving the control on the basis of existing legislation. It focusses on four key areas: the functioning of notified bodies; market surveillance; coordination in the fields of vigilance; communication and transparency.
Main achievements under the Joint Action Plan
The Plan has resulted in substantial progress, in particular in the following areas:
PIP highlighted the weaknesses in vigilance which existed in the system. The Action Plan tightens up this system by recommending that notified bodies shall carry out unannounced audits of manufacturers. Notified bodies have reported that they now are carrying out or are in the process of launching such audits. However, no reliable information is available so far on the number of unannounced audits or their effects.
Monthly vigilance teleconferences with Member States, chaired by the Commission services, now take place and are improving coordination between Member States. More than 70 specific cases have been presented for coordination. In addition, the Commission Joint Research Centre has started to analyse trends on incidents.
The Commission Staff Working Document discussed in the EPSCO Council today contains a detailed analysis of these elements as well as additional work arising from the action plan such as a Commission Recommendation on the use of a specific system for traceability of medical devices adopted in April 2013, ongoing discussion on improving product registers, Member States reports on their market surveillance activities as basis for further improvement, or discussions on incident reporting from medical practitioners and patients.
The analysis shows that on certain aspects of the Joint Action Plan progress has been limited and continued work is necessary until the new legislation comes into force. These aspects concern in particular:
The implementation of the Joint Plan has been a success. However, it is a series of short term measures designed to maximise the potential of existing legislation. A long term solution requires a thorough revision of the legal framework. The adoption of the proposed new Regulations is necessary to solve a number of outstanding issues. This relates in particular to:
Each of these points is pivotal towards ensuring patient and consumer safety.