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:
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:
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.