Medical Devices: A new regulatory landscape


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.

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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.