The European Union recently proposed tougher legislation to ramp up control of medical devices.  The new rules governing the safety and monitoring of medical devices represent a huge change in the medical technology industry. And the industry, valued at $123 billion in 2009, has significant concerns.

The proposed legislation, issued September 26, 2012, was a long time coming. The first public consultation on new medical device legislation dates back to May 2008.

The existing EU legislation on regulations for medical devices, like every regulatory regime dealing with innovative products, needs regular revision.

For example, currently, it is not always possible to trace medical devices and in vitro diagnostic medical devices back to their supplier.

Also healthcare professionals, patients and other stakeholders do not have access to essential information on what clinical evidence there is to show they are safe and effective.

After intensive discussions, what triggered the current proposal was the global scandal over fraudulent French-made breast implants in 2010, affecting tens of thousands of women and the problems occurring with certain metal-on-metal hip joint replacements.

The Commission proposals will be discussed in the European Parliament and in the Council. They are expected to be adopted in 2014 and would then gradually come into effect from 2015 to 2019.

Some key legislative changes in the new proposal include:

  • An extension of the definition of medical devices to include breast and other aesthetic implants
  • Stronger supervision of independent assessment bodies, an ad hoc network of up to 80 national agencies, by national authorities
  • Greater powers for assessment bodies to include unannounced factory inspection and regular product testing
  • Better product traceability systems

So why all of the industry backlash? The industry organization Eucomed, representing about 22,500 med tech companies in Europe, applauds many of the proposed requirements, but – and it’s a big but – it has two big issues with the scrutiny procedure.

First, Eucomed sees the expanded scrutiny as adding an extra layer of government control that can significantly lengthen the time to bring a product to market in Europe.  The organization’s chief executive, Serge Bernasconi, says that greater oversight places an extra burden on the industry but does not improve patient safety.  He stresses that it could really hurt small and medium-size companies, adding at least six months to product time to market.  Such a delay could give competitors an unfair advantage.

The industry’s other big concern:  the new scrutiny procedure will hamper innovation and delay access to life-saving medical technologies without providing an extra safety net for patients.  Bernasconi warns that the legislation “will unnecessarily push away Europe’s strong innovation and research capabilities to other continents at a time when they are urgently needed.”  Eucomed intends to advocate for removal of the oversight provision.

Clearly, introducing new medical devices has become increasingly complex, as companies must navigate new regulatory hurdles.  Often, manufacturers and regulators seem to be on opposite sides of the playing field.  Regulators face pressures to fast-track approvals while ensuring product safety and efficacy, and manufacturers risk time and resources to develop a device that may not receive approval.

If you are planning a medical device clinical trial in Europe, Clinipace’s “A Perfect Match: Choosing the Right CRO Partner in Europe” whitepaper examines the factors you need to consider to successfully identify the right CRO.  To download a copy, visit

Back to Blog