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 16, 2021

[FEATURED] Latest European Commission Figures Suggest One More IVDR Notified Body In Pipeline And Then A Gap

The European Commission has updated its figures on the status of readiness of notified bodies under the Medical Device and IVD Regulations. Three more designations are imminent, but just one under the IVDR.


The urgency of having the necessary structures in place, including notified bodies, so that manufacturers can comply with the IVD Regulation, continues to be emphasized by all stakeholders in the EU IVD sector.

Accompanying this is a general sense that there has been a lack of transparency about when additional designations will be made, which hinders companies’ preparations.

The latest figures from the European Commission show that progress is being made, but not as quickly as the sector would like.

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October 5, 2021

[FEATURED] GMed Designated Under EU IVD Regulation

In the EU, there are now six EU notified bodies designated under the IVD Regulation.

French notified body, GMed, has been designated under the IVD Regulation for a comprehensive scope of products.

This brings the total number of IVDR notified bodies to six. The latest designation comes with just nine months to go until the regulation fully applies from 26 May 2022. 

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July 6, 2021

[FEATURED] Commission Calls For Notified Body Applicants As It Recognizes EU IVD Industry In Some Trouble

The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the IVD Regulation. Delaying the regulation has long been off its agenda, but it is struggling to find solutions.

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October 29, 2018

[FEATURED] First EU Notified Body Designations Could Come Earlier Than Expected, But Caution Advised

There’s been progress toward designating notified bodies against the EU’s medtech regulations, but the developments need to be scrutinized so that the sector preserves a sense of reality about capacity issues, MedTech Europe’s Oliver Bisazza says.

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