EPSCO Reviews Joint Action Plan for Device Regulation

August 1, 2014—The European Union’s EPSCO Council on Employment, Social Policy, Health, and Consumer Affairs met on June 20 to review the European Commission Staff Working Document that analyzed the implementation of measures included in the Joint Plan for Immediate Actions under the existing medical devices legislation (known as the PIP Joint Action Plan) of February 2012.

The Commission Staff Working Document contains a detailed analysis of achievements, as well as additional work to be done 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.

These joint actions were taken by the European Commission and the member states to restore confidence following the scandal of defective breast implants produced by the Poly Implant Prothèse (PIP), a French company that was dissolved in 2011. PIP suspended the marketing of its breast implants in March 2010 after regulators found that the company’s implants contained industrial silicone rather than approved medical-grade fillers and that they may be more prone to rupture and leakage than other implants. The PIP matter and subsequent investigations were summarized in a June 2012 advisory from the UK National Health Service.

In the fall of 2013, the European Commission adopted two measures to improve the safety of medical devices as part of the joint plan for immediate action agreed upon between the Commission and the European Union member states. Endovascular Today coverage of that action is available here.

According to EPSCO, the PIP case made it clear that immediate improvements in the oversight of medical devices were needed. In response, the European Commission and member states agreed on an action plan aiming at improving control on the basis of existing legislation. The plan focuses on four areas: the functioning of notified bodies, market surveillance, coordination in the fields of vigilance, and communication and transparency.

EPSCO outlined two key achievements under the Joint Action Plan. First, based on a Commission Implementing Regulation (EU) No 920/2013 of 2013 clarifying the criteria to be met by notified bodies, member states have reassessed 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 eight countries.

Second, 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 reassessment of all certificates issued was requested. For one notified body, of the 689 certificates checked, 45 were suspended and 18 were withdrawn. Under the new Commission Implementing Regulation, such joint audits were made mandatory for new designations and redesignations of notified bodies. There are expected to be 20 to 25 such audits in 2014.

The Action Plan improves vigilance in the system by recommending that notified bodies carry out unannounced audits of manufacturers. Notified bodies have reported that they are now 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.

EPSCO advised that 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 Center has started to analyze trends on incidents.

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. Among these aspects are the organization of unannounced audits and their effectiveness; development of a common understanding of market surveillance and better coordination and communication on surveillance data; assessment of how to make best use of registries for providing data and identifying problems in the long term with devices; identification of mechanisms to detect signals, trends, and increased incident frequency more effectively based on a Joint Research Center project to be presented mid 2014; and assessment with member states of the need for, and possibilities of, organizing peer training programs.

The EPSCO announcement noted that although the implementation of the Joint Plan has been a success, 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.

EPSCO advised that 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 systems 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.