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.