As the recent PIP breast implant scandal brought to light, there has been a dramatic increase in faulty medical devices over the last decade that were able to enter the market due to serious loopholes in the current regulatory framework. At the same time, the political debate over substandard devices has increased.

However, it is not only lack of safety that causes concern but also the incorrect application of medical devices by health professionals and individual patient-users. Bodily harm includes injuries caused by implants, surgical equipment, life support machines, technologies worn on the body and controlled remotely, needlestick injuries, etc.

Moreover, medical devices policy is becoming increasingly important in the context of the implementation of the Cross-border Patients’ Rights Directive, which will allow EU patients to seek treatment in another Member State and thus subject them to different clinical environments, potentially operating to differing standards and using different devices. Given the individual requirements of national health systems, this amplifies the question as to whether or not EU-wide health technology assessments are desirable and practicable to protect patient safety.

In light of the recent problems illuminated by the PIP affair, a "stress test" of the legislation has been performed by the Commission in order to identify how the ’’lessons learnt’’ can best be addressed in the revision of the Directive. In line with its original goals, the main aim of the revised Directive will be to keep securing patients’ safety and deliver improved health outcomes, while enabling medical devices to circulate freely in the Single Market and fully exploit Europe’s innovation potential in this important sector marked by an astounding diversity of tools.

The question is, will the revision of the Medical Devices Directive go far enough to close the gaps and provide clarity and coherence regarding the elements of the approval process and the roles of the relevant stakeholders? Taking a strong patient safety approach, EPHA Briefing on Medical Devices examines some of the sticking points that must be redressed from a public health perspective.


For further information

- European Commission, DG SANCO - Medical Devices

EPHA related articles

- European Commission consults on Art 15 voluntary network - Health Technology Assessment
- European Commission proposes mandatory use of medical devices database
- A Europe without needlestick injuries

Last modified on October 15 2012.