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EU Council, Parliament confirm agreement on medical device regulations
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Representatives of European Parliament’s Environment, Public Health and Food Safety Committee and of the European Council’s Committee of Permanent Representatives voted to endorse the trilogue agreement on new rules for medical devices, including in vitro diagnostic devices, to which they agreed in May, according to a European Parliament press release.
The agreement calls for stricter monitoring and certification procedures to help ensure full compliance and traceability of medical devices, including hip implants. According to the release, legislation was also approved to tighten the information and ethical requirements for diagnostic medical devices used, for example, in pregnancy or DNA testing.
Both files were informally agreed with by the Netherlands presidency of the council and will be put to a vote by the full House early in 2017, according to the release. If formally accepted, they are expected to apply to the medical devices sector by 2020 and the in vitro diagnostic sector by 2022.
“The metal-on-metal hip scandal highlighted weaknesses in the current system. So we’ve introduced much stricter requirements for the bodies that authorize medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, will be subject to additional assessments by experts before they can be authorized,” rapporteur on medical devices Glenis Willmott (S&D, UK) said in the press release.
Willmott, whose report was approved unanimously, said, “We’ve also agreed a much stronger system of post-market surveillance so that any unexpected problems are identified and dealt with as soon as possible.”
Serge Bernasconi, CEO of MedTech Europe, an alliance of medical technology industry associations in Europe, said in a press release, “Medical technologies save lives, improve health and contribute to sustainable health care. And many of the proposed updates in the regulations are welcomed by our industry as they will enhance patient safety and facilitate access to new technology.”
Among the provisions in the agreement are random inspections of manufacturers’ facilities after devices are placed on the market and the issuance of an implant card to patients that enables patients and their doctors to track the product with which they were implanted.
References:
www.emeeting.europarl.europa.eu