On 14 June 2012, the European Parliament (“EP”) adopted a Resolution calling on EU Member States and the European Commission to introduce and implement new measures aimed at ensuring the safety of medical devices. The Resolution calls for both immediate measures based on the existing EU medical devices legislation, as well as the incorporation of additional safety measures in the legislative proposals expected to be published by the European Commission later this year.

One of the EP’s most notable requests is the introduction of a pre-marketing authorization system, similar to the system in place for medicinal products. European Commissioner John Dalli, responsible for the EU regulation of medical devices, had strongly argued against the need for a pre-market approval system at the EP on 13 June 2012, the day before the adoption of the EP’s Resolution. Immediate actions called for by the EP include the introduction and implementation of measures to: 

  • strengthen the controls on medical devices already on the market;
  • ensure that conformity assessment bodies (referred to as ‘Notified Bodies’) conduct frequent unannounced inspections of the whole supply chain;
  • improve supervision by the national competent authorities of the Notified Bodies and ensure consistency across EU Member States; and to
  • reinforce market surveillance and improve the functioning of the vigilance system for medical devices, for example by facilitating and encouraging patients and health care professionals to report adverse events and harmful effects to competent authorities.

The EP’s Resolution also urges the EU Member States carry out thorough unannounced inspections regarding high-risk medical devices, as well as devices involved in an increasing number of incidents, and to apply penalties in case of non-compliance.

The European Parliament’s Resolution follows a February 2012 call by European Commissioner Dalli on EU Member States to implement immediate actions to increase market surveillance and ensure the safety of medical devices on the basis of the existing legislative framework. The European Commissioner’s and EP’s calls for additional safety measures result from a scandal involving the use of low-quality material by a French manufacturer of breast implants.

The medical device industry should, therefore, ensure that it is prepared for immediate increased scrutiny by national competent authorities. Stakeholders are also encouraged to monitor and be actively involved in the discussions regarding safety measures to be included the European Commission’s legislative proposals expected later this year.