Jun 27, 2012

As we recently reported, the effects of the recent PIP scandal continue to ripple across the European Union. On 14 June, the European Parliament (EP) adopted a non-binding resolution which urges the European Commission to adopt proposed changes in the upcoming revision of medical device legislation. The EP posits that the PIP scandal has “brought to light a malfunction” at European and national levels and notes a lack of cooperation between Member States. The proposed changes to legislation are inspired by what the EP calls the “failure of the current system” of certification of compliance with essential health and safety requirements.

The EP also calls on the Commission to shift to a pre-market authorization (PMA) system for “certain categories of medical devices” (Class IIb and III). A PMA system would be analogous to the medicinal product regulation. The EP further requests the use of frequent and unannounced inspections and advocates improved coordination between Member States.

Furthermore, a series of immediate measures to increase post-market control are proposed. One such measure is the introduction of interconnected breast implant registers in each Member State. This register would effectively strengthen control and increase traceability. Each implant recipient will be provided an “implant passport” which will specify the unique product code of the implant. Similar tracking systems are also proposed for other types of Class III implants.

Reactions suggest that while initiatives to strengthen patient safety are welcome, it is feared that the PMA system would stifle European innovation. Heavier requirements in the pre-market phase may cause delays in the availability of medical technology and compromise European competitiveness. Medical device trade organization Eucomed reported that the Commission informed parliament that it would not introduce a PMA approach. However, there will likely be a pre-market review of the Notified Bodies’ assessments of high risk medical devices.

As discussed previously, Emergo Group believes that this revision will reflect a Medical Device Regulation versus a recast of the Directive. A Directive must be transposed into each Member State’s legislation, while a Regulation is a directly applicable “as-is.” The Cosmetics Directive 76/768/EEC recently underwent a similar revision and is scheduled to be repealed in 2013. It will be replaced by the Cosmetics Regulation No. 1223/2009.


  • Stewart Eisenhart