Following a huge health scandal involving faulty breast implants sold around Europe, the European Commission published proposals in late 2012 for a new regulatory regime for medical devices.


In December 2011 the problems affecting breast implants made by French company PIP hit the headlines, provoking Xavier Bertrand, France's then-labour and health minister, to call for tighter EU regulations on medical devices.

Bertrand said the EU should require suppliers of medical devices, including implants, to obtain the same sort of authorisation to sell their products as suppliers of prescription medicines.

The European Commission had been considering a re-vamp of its medical devices regulations for many months at the time the PIP news broke. PIP galvanised the momentum for change.

The existing EU legislation, dating to the 1990s, had not kept pace with technological changes, and EU member states interpret and implement current rules in different ways, leading to different levels of patient and public health protection in the EU.

Currently, it is not always possible to trace medical devices and in-vitro diagnostic medical devices back to their supplier. Patients, healthcare professionals and other interested parties do not have access to essential information on how medical devices and in-vitro diagnostic medical devices have been assessed, and what clinical evidence there is to show they are safe and effective.

On 26 September 2012, the Commission released new proposals, including:

  • A regulation to update the existing directive and regulations dealing with medical devices; and
  • A regulation on in-vitro diagnostic medical devices.

The proposal on in-vitro diagnostic devices will affect testing laboratories and equipment used in hi-tech genetic evidence, but is of less significance to the much larger market for medical devices.

Under its proposals, member states will be able to review, scrutinise, and comment on assessments performed by notified bodies, provided the assessment meets certain criteria, such as high-risk (Class III) devices, devices that represent public health concerns, 'novel technologies' and files from notified bodies with a history of significant discrepancies.

The proposals will now go to co-decision procedure with the European Parliament, where the question of whether they go far enough will be in the spotlight.


Defining medical devices

The term 'medical device' covers a wide range of products both used internally and externally by patients and doctors. They can include sticking plasters, contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

These are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment and prevention of disease. They are a ranked from Class I, a low-risk category that would include spectacles, to high-risk Class III items such as hip replacements and pacemakers.

Current EU approval process for medical devices

A European Council resolution of May 1985 set out a blueprint for technical harmonisation of authorisation of medical devices.

Authorities within the member states set the legal safety and performance requirements to be met by manufacturers for their products. These are laid down in the 'Essential Requirements' of the medical devices directives.

They complement this with detailed Harmonised European Standards covering not only the products themselves but also the materials they're made of and the tests they must pass, including standards on clinical investigations.

These standards are available to doctors and manufacturers to help determine safety and are the subject of continuous update to keep pace with the latest in science and technology.

In addition, there is a formal mechanism for authorities or the European Commission to intervene and de-list or augment a standard should there be a safety concern.

Authorities then select legally and technically independent competent bodies - or notified bodies - to check that manufacturers are conforming to the directives. 

Governments choose, if they wish, to designate bodies, and if they do, they must check if the body is capable of covering the products concerned and thereafter monitor the body and its work.

Notified bodies must be able to demonstrate that they have the clinical, scientific and technical competence to carry out their assessments.

Once designated, the notified body's job on behalf of the authorities is to initially verify and check manufacturers against the legal requirements and standards before they market their products in the EU. To improve co-operation, the Commission helps organise exchanges between the authorities responsible for market surveillance in order to coordinate uniform implementation.

The new EU device proposal

In June 2012, the European Parliament approved a resolution aimed at improving the current legislative framework for medical devices, calling on the European Commission to shift to a "system of pre-market authorisation for certain categories of medical devices, including at least, medical devices of Class IIb and III".

Class IIb includes all non-invasive devices intended for modifying the biological or chemical composition of blood or other body liquids, while the Class III devices are intended to control, diagnose, monitor, or correct a defect of the heart or central circulatory system.

The Commission’s proposal calls for:  

  • More powers for notified bodies, to ensure thorough testing and including unannounced factory inspections;
  • An extended database on medical devices, providing comprehensive and public information on products available on the EU market;
  • Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns;
  • Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices.

Also included is the creation of a Medical Device Coordination Group comprised of members representing national competent authorities in the field of medical devices to ensure better coordination between member states. 

Under the proposed mechanism, member states will be able to review, scrutinise and comment on assessments performed by notified bodies, in relation to high-risk (Class III) devices, devices that represent public health concerns, 'novel technologies' (a category yet to be defined) and files from notified bodies with a history of significant discrepancies.

The scrutiny process would have to be called for within 15 days of receipt of a new application, and the committee would have 90 days. The committee could request supplemental information from the notified body. In total, the mechanism could add 3-6 months to the approval process.

Many fear that such a delay would not only increase manufacturers' time to commercialisation, but also slow innovation in the EU and hinder patient access to new technologies.

The existing PMA approach in the US

In the United States, the Food and Drug Administration (FDA) controls a pre-market approval (PMA) process for Class III devices, the highest risk of three possible classifications.

In 2010, Dr Joshua Makower, one of America's leading med-tech entrepreneurs, led a study that detailed how patients in Europe are getting access to new therapies an average of two years before patients in the United States due to regulatory challenges at the FDA.

Data from the survey indicate that European regulatory processes allow innovators to make new medical technologies available to patients more quickly and at a lower cost.

Industry: PMA approach is a step backwards

A pharma-like PMA approach to medical devices simply could not work in the EU, says Eucomed. John Brennan, Eucomed's director for regulatory and technical affairs, says one has to remember that Europe's use of the government-appointed notified bodies was a deliberate choice for medical technology, not an oversight.

"It was chosen to make sure that people have the fastest access possible to safe medical devices that save lives. Of course there is an economic angle as well for Europe Inc.: making sure that innovation stays in Europe," Brennan said.

A report of the Boston Consulting Group has also shown than medical device recalls in the US and Europe occur at the same rate while the approval process in Europe is significantly faster.

The decentralised oversight in Europe, which is the essence of the regulatory system, allows people to benefit from the latest products while guaranteeing the highest level of patient safety.


“We want to retain the notifying bodies, but to ensure that they all apply the same level of competence,” said Paola Testorri Coggi, director-general in the European Commission’s health department responsible for the proposals.

“This will be the big debate because it is true that there are some who want pre-market authorization (PMA). We think that we should not change the model and we think by stricter supervision we can achieve the same level of security, without creating the long delays that exist in those countries where they have PMA,” Testorri Coggi added.

“We welcome the joint assessment of the notified bodies that will take place, and broadly on scrutiny, but we have some concerns about whether the national authorities will have to bear the majority of the burden for the scrutiny procedure, checking and verifying the details could be time consuming and cost extra resources, and it is not clear where these are coming from,” said Pat O’Mahony, chief executive of the Irish Medicines Board.

O’Mahony said that the regulation was already stirring closer co-ordination amongst regulatory bodies and he announced that on 31 January the Irish presidency would convene a joint meeting for stakeholders to discuss the issue together in Dublin.

“The review of the medical devices directive is a matter of life and death for some of our members,” said Susanna Palkonen, vice president of the European Patient’s Forum. We are delighted that patient’s will be able to make reports directly to the authorities because we believe that patients can play a big role.

“We want to retain a non-centralised system for registering medical devices because we have always been able to use innovative technology years before our Japanese and US colleagues,” according to Angelo Auricchio, president of the European Heart Rhythm Association and member of the board of the European Society of Cardiology. “I do not like the plans fro scrutiny. When you start scrutiny procedures, they say that process will take two or three weeks but then from that it turns into months and years. It will develop into an unpredictable time.”

“What is important is that any changes fulfil three criteria: that they increase patient safety, maintain the fast introduction of innovative technology and pave the way for sustainable heathcare,” said Zeger Vercouteren, executive director of government affairs and policy with Johnson & Johnson. “In the case of the proposals for scrutiny procedure, none of these three criteria will be fulfilled. We understand that there was political pressure, but we find it the ugly spot on the Commission’s proposal, it is too bureaucratic.”

“I urge all decision makers who want to make fundamental changes to the European system for medical devices to tread with caution. European patients and European medical research and innovation have benefitted heavily from a system that is the world’s fastest in providing patients with life-saving technologies while not compromising safety,” said former surgeon and Eucomed Chairman Dr Guy Lebeau.

“I fully agree that changes need to be made to the current regulatory framework but let’s make sure we keep the best system for patients and medical progress in Europe,” Legeau added.

“European industry is committed to providing medical technologies that improve people’s lives while at the same time being cost-effective,” said Serge Bernasconi, chief executive of Eucomed.

“Europe has become a leader in healthcare innovation, which is now more than ever needed to cope with the increased pressure on national healthcare budgets. The current regulatory framework has provided a high level of safety for patients in Europe without delaying them access to life-saving medical technologies, which will always remain paramount. But let’s not unnecessarily push away Europe’s strong innovation and research capabilities to other continents at a time when they are urgently needed,” said Bernasconi.


  • June 1990: EU health ministers adopt Council Directive 90/385/EEC relating to implantable medical devices
  • June 1993: EU health ministers adopt Council Directive 93/42/EEC concerning medical devices generally speaking
  • Oct. 1998: EU institutions adopt Directive 98/79/EC on in vitro diagnostic medical devices
  • Feb. 2003: Reclassification of breast implants
  • Aug. 2005: reclassification of hip, knee and shoulder joint replacements
  • May 2008: European Commission launches public consultation on the revision of the legal framework for medical devices
  • June 2010: Commission publishes further consultation on revision of in vitro diagnostic medical devices directive
  • 26 Sept. 2012: Commission adopts proposals for regulations on medical devices and a and in vitro diagnostic medical devices
  • 28 Mar. 2013: ENVI rapporteur's report expected
  • 3 May 2013: Deadline for Amendments to rapporteurs' reports
  • 29 May 2013: ENVI Committee debate on amendments
  • 10 July 2013: ENVI vote
  • Sep. 2013: Plenary vote