Innovation in medical devices benefits patients, doctors and the medical technology industry. The European Commission has proposed legislation aimed at enhancing safety, traceability, and transparency without inhibiting innovation.
Medical devices in the EU
Medical devices comprise more than half a million different products, from adhesive bandages, pregnancy tests and contact lenses to X-ray machines, pacemakers and HIV tests.
The medical device industry is highly innovative. Europe’s 25 000 medical technology companies – mostly SMEs – filed over 10 000 patent applications in 2012. The industry has more than half a million employees. The European market is estimated at around €100 billion annually.
In the EU, new medical devices come to market earlier than in the US, which has a time-consuming centralised approval system. For European patients and doctors, this results in more treatment options, better quality of life as well as cost savings.
The current legislation on medical devices, introduced in the 1990s, divides medical devices into four different risk classes. Unlike with pharmaceuticals, there is no pre-market authorisation for medical devices – it is the manufacturer’s responsibility to ensure regulatory conformity. Member States (MS) designate ‘notified bodies’ – organisations that carry out verification of manufacturers of medium and high risk medical devices.
|PIP breast implant scandal
In 2011, it became known that over half a million women worldwide, among them 100 000 Europeans, had received deficient breast implants, revealed to have contained cheap industrial silicone. The French firm Poly Im¬plant Prothèses (PIP) had sold these products for over ten years. PIP allegedly concealed the evidence during checks, announced in advance, by the notified body.
The European Parliament resolution on defective silicone gel breast implants of 14 June 2012 called on the European Commission (EC) to develop legislation to ensure the safety of medical devices, and urged immediate measures based on current legislation.
In September 2013, the EC adopted measures to tighten the designation and surveillance of notified bodies, and requiring notified bodies to perform unannounced factory inspections.
European Commission’s proposal
In September 2012, the EC proposed new Regulations on medical devices and in vitro diagnostic medical devices (e.g. diabetes test strips and HIV antibody tests), which clarify the scope and aim to
- improve market surveillance,
- strengthen notified bodies, and
- ensure transparency and the traceability of products.
The medical technology industry supports the proposal and highlights the importance of a decentralised approval system. In-vitro diagnostics manufacturers also spoke out in favour.
The European Consumer Organisation (BEUC) considers the proposal an important step in strengthening market surveillance, but calls for additional measures, including centralised pre-market assessment for some high-risk devices.
On 25 September, the Environment Committee (rapporteur: Dagmar Roth-Behrendt, S&D, Germany) voted amendments that would introduce ‘special notified bodies’, designated by the European Medicines Agency, to assess the highest-risk devices, as well as case-by-case checks by a new expert body – the Assessment Committee for Medical Devices.
Regarding in-vitro diagnostic medical devices (rapporteur: Peter Liese, EPP, Germany), the Committee’s amendments provide for an ethics committee and provisions on informed consent and genetic counselling.
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