The current EU regulatory framework for medical devices, other than in vitro diagnostic medical devices, consists of two Directives adopted in the 1990s which goal is to ensure the smooth functioning of the internal market and a high level of protection of human health and safety. Medical devices are not subject to any pre-market authorization by a regulatory authority but to a conformity assessment which, for medium and high risk devices, involves an independent third party, known as “notified body”. Notified bodies, of which there are around 80 across Europe, are designated and monitored by the Member States and act under the control of the national authorities. Once certified, devices bear the CE marking which allows them to circulate freely in the EU/EFTA countries and Turkey.
The existing regulatory framework has demonstrated its merits but has also come under harsh criticism, in particular after the French health authorities found that a French manufacturer (Poly Implant Prothèse, PIP) had for several years apparently used industrial silicone instead of medical grade silicone for the manufacture of breast implants contrary to the approval issued by the notified body, causing harm to thousands of women around the world.
To overcome flaws and gaps between participating countries and to further strengthen patient safety, the European Commission has issued a Proposal for a Regulation on medical devices on the 26th of September 2012. This Proposal is adopted alongside a Proposal for a Regulation on in vitro diagnostic medical devices.
Among the legal elements of the Proposal are some articles that concern clinical evaluation and clinical investigation.
“Clinical evaluation” means the assessment and analysis of clinical data pertaining to a device in order to verify the safety and performance of the device when used as intended by the manufacturer.
“Clinical investigation” means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device. It is the equivalent of clinical trials in the field of medicinal products.
Among the requirements that concern clinical investigations:
– In the case of implantable devices and devices falling with class III, clinical investigations shall be performed unless it is duly justified to rely on existing clinical data alone
– Every step in the clinical investigation, from first consideration of the need and justification of the study to the publication of the results, shall be carried out in accordance with recognized ethical principles, as for example those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th World Medical Association General Assembly in Helsinki, Finland, in 1964, and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, in 2008.
– Proof of insurance cover or indemnification of subjects in case of injury shall be provided, according to the national law.
What are the next steps?
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.
European Commission Website: http://ec.europa.eu/index_en.htm