This is the third post in a series written by guest blogger Jeremy Petitprez, a student at the Paris Bar School. Jeremy holds a master’s degree in pharmaceutical law from the Paris Law Faculty (Faculté de droit de Paris).
In the 1990s, the European Union (EU) regulation of medical devices across the European Economic Area (EEA) was harmonized under three medical device directives. At present, this regulatory regime faces criticism over the complexity of its legal framework, deficiencies in its ability to address emerging technologies, and the lack of uniformity across member states.
In 2008, the European Commission conducted a public consultation seeking input from industry members, regulatory authorities, health care professionals, and other stakeholders regarding the regulatory system and possible targets for reform. A second consultation in 2010 solicited opinions regarding changes to in vitro diagnostic regulation, while a conference co-chaired in March 2011 by the EU commissioner for health and consumer policy discussed the topic of “adapting the EU’s medical device legislation to the needs of tomorrow.” The Commission’s Work Program 2011 now includes the recast of the three directives as an initiative for the 2012 legislative agenda. A proposed roadmap for the recast was released in November 2010.
The Commission’s roadmap offers a list of potential options. These include replacing the Medical Device Directive and the Active Implantable Medical Devices Directive with one comprehensive directive, issuing an updated directive to replace the current In Vitro Diagnostic Directive, and/or encouraging greater harmonization across EEA states. More radical proposals include substituting regulations (which are directly binding and applicable on all EU member states without the need for implementation) for the more flexible directives-based approach (which allows member states to implement the objectives in their own national laws in a variety of ways) and establishing a centralized EU medical devices regulatory authority comparable to the European Medicines Agency (EMA), which regulates certain pharmaceuticals on a supranational level.
In February 2011, five of the most prominent Notified Bodies (NB) issued a voluntary Code of Conduct for Notified Bodies, articulating minimum qualifications for NB personnel, establishing rules for the execution of conformity assessments, and offering guidelines by which NBs may better harmonize their assessments. Participation in the code is currently voluntary and available to any recognized NB. Enforcement measures are currently being designed and are expected to be published by January 1, 2012.