Restoring confidence in medical devices: Action Plan after the PIP scandal tightens control in Europe

On 20 June, the EPSCO Council 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 Consumer Policy Commissioner Neven Mimica. “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 focuses on four key areas: the functioning of notified bodies; market surveillance; co-ordination in the fields of vigilance; communication and transparency.

Main achievements under Joint Action Plan

The Plan has resulted in substantial progress, in particular in the following areas:

• Based on a Commission Implementing Regulation (EU) No 920/2013 of 2013 clarifying the criteria to be met by notified bodies, member states have re-assessed the qualifications and the scope of activities of their notified bodies. This resulted in corrective measures or limitations in the scope of activities of notified bodies in 8 countries.

• By May 2014, voluntary joint audits of notified bodies by teams involving auditors from several member states and the Commission have been carried out in 22 out of 23 countries having notified bodies. The last audit in the remaining country has already been scheduled. The audits have resulted in the identification of problems in the way notified bodies operated. Where major shortcomings were identified, immediate corrective action was taken, including temporarily suspending or limiting the scope of activities of the notified body concerned. In one case, the notified body is no longer able to issue certificates. Where necessary, a re-assessment of all certificates issued was requested. For one notified body of the 689 certificates checked, 45 were suspended and 18 withdrawn.. Under the new Commission Implementing Regulation, such joint audits were made mandatory for new designations and re-designations of notified bodies. 20-25 such audits are foreseen for 2014.

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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 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 organisation of unannounced audits and their effectiveness;

• development of a common understanding of market surveillance and better co-ordination and communication on surveillance data;

• assessment of how to make best use of registers for providing data and identifying problems on the long term with devices;

• identification of mechanisms to detect signals, trends and increased incident frequency more effectively based on a JRC project to be presented mid 2014, and;

• assessment with member states of the need for, and possibilities of, organizing peer training programmes.

The implementation of the Joint Plan has been a success. However, it is a series of short term measures designed to maximize 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:

• The scope of the legislation,

• the governance of the system and its transparency,

• certain obligations of notified bodies, in particular in relation to mandatory unannounced audits,

• clinical evaluation,

• the risk classification of devices and the safety and performance requirements,

• the obligations of economic operators,

• the reporting of incidents by users and patients to the Competent Authorities,

• certain aspects relating to vigilance system and market surveillance,

• the role and the functioning of the database Eudamed and the access of notified bodies to Eudamed, and;

• the traceability of devices.

Each of these points is pivotal towards ensuring patient and consumer safety.

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