Medical Device Rules in the EU; the Changes Prior to the New Regulations

June 25, 2014

As an immediate response to the PIP (silicone breast implant) crisis, in February 2012 the European Commission (EC) agreed to a Joint Plan for Immediate Actions (also called PIP Joint Action Plan) with the EU member states. This plan aimed to tighten controls and restore patient confidence in the regulatory system on the basis of the existing EU medical devices legislation, pending the adoption of new rules. It focused on four key areas: the functioning of “notified bodies,” market surveillance, coordination in relation to product vigilance, and communication and transparency.

On 18 June 2014, the EC published a report on the implementation of the joint plan over the previous two years. This sets out the achievements of the plan and, importantly, identifies some particular aspects that should be continued and intensified.

The two new EU medical devices regulations likely will be adopted in 2015, but companies selling medical devices in the EU should continue to follow discussions on the joint plan, since it impacts the sale of medical devices in the EU right now.

The Joint Plan for Immediate Actions resulted from the EC calling on the governments of the 27 (now 28) EU member states to take immediate action to protect patients in the EU by tightening controls on implantable and other high-risk medical devices. European Health and Consumer Policy Commissioner John Dalli made this call subsequent to huge public concern in the EU following the PIP breast implant incident. Commissioner Dalli requested action, under the current legislative framework (which is still in place), in a number of areas relating to high-risk devices, including greater use of unannounced inspections (“dawn raids”), spot checks and testing of products, better reporting of adverse events, and support for the development of tools to ensure both the traceability and the long-term monitoring of devices. This became the basis of the joint plan.

The joint plan was intended to bridge the period up to implementation of the new regulatory regime to be put in place in the EU. (The two new regulations were proposed by the EC in September 2012; see our legal alert summarizing these rules.) As several of the actions included in the plan mirror parts of the new proposed rules, the plan paves the way for early implementation of some of the new requirements and should substantially facilitate their application in due course.

The 18 June 2014 report on the implementation of the joint plan concludes that substantial progress has been and continues to be made in its implementation. Of particular interest to manufacturers/suppliers active in the EU are the following points:

  • Notified bodies. Member states have reassessed the qualifications and the scope of activities of their notified bodies. This has resulted in corrective measures or limitations in the scope of activities of notified bodies in at least eight countries. (Notified bodies are organisations or companies designated by the EU member states to carry out control of manufacturers of medium- and high-risk medical devices. There are about 80 notified bodies for medical devices in the EU.)
  • Unannounced audits. A majority of member states have requested their notified bodies to carry out unannounced audits and have asked notified bodies to ensure they are informed about incident reports. Notified bodies have reported that they now are carrying out or are in the process of launching the unannounced audits.
  • Vigilance reporting. The EC’s Joint Research Centre (JRC) has launched a pilot project on analysis of medical devices incident reporting. The objective is to identify mechanisms for a more effective detection of signals, trends and increased incident frequency.
  • Traceability. An EC recommendation on the use of a specific system for traceability of medical devices (UDI) was adopted in April 2013.
  • Product registers. Dialogues with member states regarding product registers for implantable devices are ongoing.
  • Market surveillance. Most member states have reported on their market surveillance (product checking) activities (intensity, targets, types of measures taken and resources available). This information has been used as a base for assessing the need for further improvement.

In addition to this overview of what has been done, the report identifies particular areas in which continued work is needed in order to implement the joint plan. It therefore can be expected that over the next few months there will be movement in these areas:

  • The organisation of unannounced audits and their effectiveness.
  • Development of a common understanding of market surveillance and better coordination and communication on surveillance data. Notified bodies are being encouraged to carry out proactive surveillance.
  • Assessment of how to make best use of product registers for providing data and identifying long-term problems with devices.
  • In the area of vigilance reporting, identification of mechanisms to detect signals, trends and increased incident frequency more effectively based on a report to be published in mid-2014.

Finally, of interest is that the report finds it impossible, under the current legislation, to implement a number of aspects of the joint plan. Although there is little doubt that the two new proposed EU medical devices regulations will be adopted (probably in 2015), this must make it even more likely that they ultimately will see the light of day and become the centrepiece of medical devices regulation in the EU. We are following the progress of these regulations closely and have reported on them on our FDA Life blog.