November 23, 2021

[FEATURED] MRA Or Not, Swiss Medtech Industry Urges Maximum Convergence With EU MDR

Swiss domestic medtech manufacturers reluctantly accept Switzerland’s new status as a third country to the EU, but the Swiss industry is anxious that new national regulations do not impose higher hurdles than the EU MDR. At present, there is a risk of that happening.


wiss medtech manufacturers appear to have taken a pragmatic view of the country’s newfound status as a third country to the EU, in the months since the EU Medical Device Regulation took effect. In the absence of the mutual recognition agreement (MRA) with the EU, the MDR does not apply directly in Switzerland, as the medical device directives did, so Switzerland enacted its own national Medical Device Ordinance (MedDO/MepV).

The revised Swiss medical device legislation was put in place to maintain Switzerland’s orientation towards both the MDR and the future IVD Regulation, regarding product quality, safety and efficacy. At some point in the future, a Swiss referendum might lead to a situation where mutual recognition and free market access are once again in place for both parties.

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November 8, 2021

[FEATURED] EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due ‘By December’

The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.


In a best-case scenario 61% of today’s IVDs will be certified by the 26 May 2022 IVD Regulation deadline, and in a So far, only five standards have been published in the Official Journal of the EU in the context of the EU’s Medical Device Regulation, and four in the context of the IVD Regulation.

But more standards are due to be officially published this year, including the European versions of the international quality system standard EN ISO 13485 and of the risk management standard EN IS0 14971, standards that are the very foundation of the implementation of the MDR and IVDR but which are now going to be officially available later than the originally anticipated October deadline.

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August 24, 2021

[FEATURED] EU Prioritizes Risk Management And Quality System Standards Now Legal Basis In Place

Ensuring key standards for MDR and IVDR compliance are available for manufacturers is one of the top priorities for the European Commission after the summer break.

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August 3, 2021

[FEATURED] MDR Practicalities: Companies Explain Impact Of Notified Body Timings And Questions Process

Manufacturers initiate an intense communication process when they apply for notified body conformity assessment of their product or quality system. How long does this last, and what impacts its length?

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July 27, 2021

[FEATURED] EU Coordinates Market Surveillance For The First Time: Pilot Being Launched

‘JAMS’ has been strengthening the European market surveillance network and helping lower-resourced member states develop skills and capacity. Coordinated pilot project work is next.

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