March 26, 2020 / 8:20 AM / 4 days ago

Coronavirus delay to EU medtech rules gives Swiss firms 12-month reprieve

ZURICH, March 26 (Reuters) - The European Union is pushing back new rules governing medical device safety by a year due to the coronavirus, taking pressure off Switzerland to sign a new treaty with the bloc, the Tages-Anzeiger newspaper reported on Thursday.

Swiss manufacturers planning to export products under the EU’s proposed new Medical Device Regulation have said they would lose unfettered access to its biggest market for exports, should Switzerland and the EU fail to reach a deal on the new treaty.

The so-called “framework agreement” calls for Bern to routinely adopt single market rules, and medical device makers feared a continued impasse would leave their products without European recognition once the new safety rules were enacted.

But Stella Kyriakides, European Commissioner for Health and Food Safety, said on Wednesday that the bloc would wait on the new rules, on grounds that a shift now could hamper access to lifesaving equipment needed in the current crisis.

"Vital devices needed to treat COVID19 patients must remain available on markets. For that reason, at the EU Commission, we are working to put forward a proposal to delay the implementation of the new medical devices regulation by 12 months," Kyriakides' said in a Tweet. [ ]

That means Swiss makers of hip implants, orthopedic products and other devices will get a reprieve of a year, as their products can continue to be exported to Europe under existing rules, the Tages-Anzeiger said.

The Swiss remain under EU pressure to sign the broader treaty, after having dragged their feet for months while trying to forge domestic consensus - in the process annoying EU officials and triggering a fight over cross-border stock trading. (Reporting by John Miller; Editing by Angus MacSwan)

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