EU Commission revises “outdated” medical device regulation

By Emma Jane Cash

- Last updated on GMT

© iStock
© iStock
The EU Commission has released the revised regulations for the marketing of medical devices, simplifying the confusing between food and medical device, after outlining the changes - including post-market surveillance and increased traceability - back in 2012.

The new regulation​ replaces legal texts dating back to the early 1990s, causing experts to say it was “overdue”​.

The Council and the Parliament reached political agreement last summer on the revisions and have now undergone a legal-linguistics review.

The updated regulations clarify the distinction between food and medical devices, stripping some food products of their medical device status, including cranberry​, whilst others were given medical status, like fibre-containing products.

In a statement given by the Council, it was said the revisions “aim at modernising the existing legislative framework for the marketing of medical devices and to overcome legal gaps, thereby supporting innovation and the competitiveness of the medical device industry”.

The regulation cements guidelines put in place for all European Member states to follow to ensure a high level of health and safety protection, free and fair trade throughout the EU and scientific progression.

“It is important that it is a regulation, and not a directive, so Member States do not have opportunities to insert provisions that hamper the single market and protect local interests,”​ said Luca Bucchini, food risk specialist at Hylobates.

A problem that lay in the outdated regulation is all ingested medical devices, former food supplements, enjoyed a very low threshold of regulation and some member states were criticised for being too lenient on borderline products.

The revisions aim to simplify this confusion; however Bucchini said this clarification could lead to manufacturers re-classifying their products.

“[The regulation] formally separates food from medical devices with no ambiguity. But the devil is in the details, and, especially with the Nutrition and Health Claims Regulation (NHCR), some companies have sought to re-classify their supplements as medical devices to maintain some of the past claims,”​ he said.

Mineral and fibre containing products are being sold as medical devices and the European Commission set out to classify such products as III – high risk products – which would have raised prices dramatically.

However, after debates in the Commission, most of the products have been classified as IIb – high to medium risk – and more evidence and studies on the products is required.

Under the regulations, there is no system for pre-market authorisation of medical devices.

The transition period for the revision is long – three years for the regulation to apply followed by a further five years – with effect likely from 2020.

Bucchini said this may prompt authorities to tighten their interpretation of current laws with more immediate effect.

The regulation covers home-use items such as plasters, pregnancy tests and contact lenses, as well as X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

Aesthetic products which are similar to medical devices in terms of functioning and risk are also covered.

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