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EU adopts new rules on medical devices

The European Parliament has adopted two new EU regulations on medical devices and in-vitro diagnostic medical devices that aim to improve public health and patient safety. 06 Apr 2017

The regulations on  medical devices (566-page / 2.47MB PDF) and in vitro diagnostic medical devices (477-page / 2.18MB PDF) were first proposed by the Commission in 2012. They will help to ensure that all medical devices are safe and perform well, the Commission said.

Under the new rules panels of independent experts will control high risk devices, such as implants, and clinical trials taking place in more than one country will be subject to one coordinated assessment rather than independent national assessment, the Commission said.

Manufacturers will also only need to register each device once, rather than managing multiple registrations in different countries, it said.

Many aesthetic products, such as coloured contact lenses, that are currently regulated as general products will now be treated as medical devices and subject to stricter controls, the Commission said.  

Other changes include a financial mechanism to ensure that patients are compensated if they are harmed by defective devices, the Commission said.

A unique device identifier will be required for every product so that it can be found in the new European database of medical devices (EUDAMED).

Once devices are on the market, manufacturers will be obliged to collect data about their performance and EU countries will coordinate their market surveillance, the Commission said.

The new rules will improve market surveillance and traceability and make sure that devices reflect the latest scientific and technological expertise, it said.

Elżbieta Bieńkowska, commissioner for internal market, industry, entrepreneurship and SMEs said: "I'm extremely happy that our push for stricter controls of medical devices on the EU market will now become a reality. Whether for medical devices, cars or other products, we must ensure stronger supervision in the interest of our citizens. We should not wait for another scandal instead we should start a discussion how to strengthen European oversight over member states' market surveillance activities."

Intellectual property law and life science expert Allison Sadick of Pinsent Masons, the law firm behind Out-Law.com said: "The introduction of these new rules by the Commission not only means that there is tighter regulation of medical devices but recognises that medical devices have made significant technical advances and valuable contributions to the field of medicine such that it warrants the Commission's attention and a higher level of regulation akin to medicines."

"In light of the new rules and revision to the medical devices framework by the Commission, this would be an opportune time to ensure there is parity between the regulation and corresponding intellectual protection of medicines and high risk medical devices so that medical device manufacturers are seemingly not at a disadvantage for bringing innovative devices to market versus their pharmaceutical counterparts," she said.

"This is particularly the case where patent term extensions in the form of supplementary protection certificates are only being granted in respect of medicines and not for high risk, more invasive and more complex medical devices despite these having to demonstrate similar regulatory/conformity assessments," said Sadick.

To give manufacturers and authorities time to adapt, the new regulation on medical devices will apply three years after the date on which it is published in the OJEU, and the new regulation on in vitro diagnostic medical devices will apply five years after its OJEU publication date, the Commission said.