Could New European Medical Device Safety Laws Be Delayed?

There have been calls for new regulations on the safety of European medical devices to be postponed, because regulators aren’t ready for them to be introduced.

The International Consortium of Investigative Journalists reported that the German and Irish health ministers are leading calls for elements of the new legislation to be postponed because of worries that the new laws will result in shortages of certain medical devices.

The legislation in question was passed in May 2017 and relates to the licensing and monitoring of medical devices.

But speaking at a summit of health ministers earlier this month, Jens Spahn, from Germany, told attendees that they should push for some elements of this new legislation to be put on hold, as it is due to come into force in May next year.

“We don’t want bottlenecks in the provision of [medical] devices for patients in May,” he asserted. Mr Spahn added: “We’ve only got a year until [the new laws] enter into effect… We would encourage the commission to bring in a corrigendum [correction to the legislation].”

The issue is that there aren’t enough private certification firms, known as ‘notified bodies’, to process medical device safety licenses within the EU. At present, just two have been cleared to do so, which is not enough to meet demand.

To address the problem, Mr Spahn is recommending that a grandfathering clause in the legislation is expanded, which would mean many existing medical devices are able to fall outside the new law until 2024.

Several other health ministers who attended the summit, including those from Bulgaria and Belgium, supported the moves suggested by Mr Spahn and his Irish counterpart Simon Harris.

Mr Harris told attendees at the summit that it’s “important that we are honest with each other and assess the state of readiness”.

However, the news provider noted that the lobby in the medical device industry is powerful and that both Ireland and Germany are among the world’s top exporters of medical devices, with both countries having many workers employed in the sector.

European commissioner for health Vytenis Andriukaitis is more optimistic about the introduction of the regulation. He has rejected the claims that there won’t be enough notified bodies, stating that 20 will be ready by May 2020, describing the date as “a realistic and achievable deadline”.

Regulatory Focus recently reported on a fact sheet produced by the European Commission, which warned that there was the potential that some devices could “become temporarily unavailable”.

Speaking to the news provider, Gert Bos, executive director and partner at Qserve consultancy, said part of the issue stems from a lack of coordination across the EU. “Nobody knows if and what products will remain available to health care providers as there is no EU-wide portfolio coordination taking place,” he asserted.

How this might affect the UK is yet to be seen, given that May is after the current deadline for the country leaving the EU.

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