EU Council, Parliament reach agreement on rules for medical devices

The European Union agreed to new rules on medical devices and in vitro diagnostic medical devices following a trilogue meeting on May 25, 2016, according to a European Council press release.

The Netherlands presidency of the council and representatives of the European Parliament reached a political agreement, which is subject to approval by the European Council’s Permanent Representatives Committee and the European Parliament’s Environment, Public Health and Food Safety Committee. The two agreed-on draft regulations are expected to achieve a two-fold aim: to ensure medical devices and in vitro diagnostic medical devices are safe; and to allow patients to benefit from innovative health care solutions in a timely manner. Medical devices and in vitro diagnostic medical devices cover a wide range of products, which includes sticking plasters and hip replacements.

“This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases. The deal reached will improve patients’ health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25,000 medical device manufacturers in the [European Union] E.U., many of which are [small- and medium-sized enterprises] SMEs and which employ more than half a million persons,” Minister of Health of the Netherlands and President of the European Council, Edith Schippers, said in the press release.

MedTech Europe, an alliance of medical technology industry associations in Europe, said in a press release it was pleased political agreement was reached on these regulations.

“As said before, the medical industry recognizes the importance of these updated regulations. The implementation will require substantial resources from all stakeholders, including industry. It is thus essential to keep the overarching goals of patient safety and innovation in mind during the translation into implementable rules,” Serge Bernasconi, chief executive officer of MedTech Europe, said.

According to information in the council press release, the safety of medical devices could be improved through this agreement because the rules on placing these devices on the market will be strengthened and include stiffer rules for independent bodies that assess devices prior to marketing.

Once these devices are on the market, the release noted that the surveillance will be tightened. The rules will also strengthen the scope of notified bodies by national authorities. Under the deal, experts may perform an additional check of certain high risk devices before these enter the market.

Toward increased transparency for patients and traceability, a central database will be created to track medical device information. Patients who are implanted with a device will also be given key information on the product.

The European Council’s Permanent Representatives Committee will be invited to endorse the agreement, probably in mid-June 2016.

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