In April 2021, the Swiss Federal Council published the draft IVD Ordinance for public consultation. The draft regulation referred to the In Vitro Diagnostic Device Regulation (IVDR) throughout. Since then, industry has been waiting for news regarding whether the proposed IVDR based legislation will be implemented or not.

Why does this matter? Why wouldn’t Switzerland transition to the IVDR?

Background

When the Swiss Federal Council published the IVD Ordinance for public consultation, Switzerland and Europe were still in discussions for the new Institutional Framework Agreement (‘InstA’) and an amendment to the existing Mutual Recognition Agreements (MRA) to also include the MDR and IVDR.

However, on 26 May 2021 the Swiss Federal Council confirmed they will not sign InstA. The EU Commission, in turn, committed to its stance that without InstA, it will not update any existing MRAs – including the one related to mutual recognition of the new Medical Device Regulation (MDR). Therefore, on 26 May 2021 the MRA between Switzerland and the European Union lapsed, as it relates to medical devices. This stranded Swiss manufacturers as they scrambled to appoint EU authorized representatives, no longer being part of the European ‘single market’. See this previously published update for more information.

The MRA still recognizes the In vitro Diagnostic Devices Directive (IVDD) 98/79/EC. However, the IVDR date of application (26 May 2022) is quickly approaching.

In the meantime, the EU Commission has proposed longer IVDR transition timeframes, which will delay the compliance deadline for most IVDs currently on the market. While on the surface this seems like good news, it likely does not help Switzerland’s situation. This is because some aspects of the IVDR will apply to all IVDs on its date of application, even if the IVDR compliance date has been postponed for that particular IVD device risk class. Click here to read more.

What is the latest?

On the 26 May 2021 date of separation, the MDR had already been implemented into Swiss national law. Switzerland had to quickly react and modify the Medical Devices Ordinance to account for suddenly becoming a third country from Europe. However, the IVDR has not yet been transposed into Swiss national law. The question industry is now asking is: Should it be?

Several Swiss industry organizations have published their rejection of the draft Swiss IVD legislation and called for another public consult. Their feedback was clear: the legislation should match the current reality.

The draft IVD legislation was published when the Swiss Federal Council and the EU Commission were still working toward a new or revised agreement. However, those discussions have failed and it’s not clear if they will be picked up again, much less resolved, by the IVDR’s date of application. Therefore, some parts of the IVDR will be impossible for Switzerland to implement, such as reporting and registration in EUDAMED, the central European medical device databank.

If the Swiss Federal Council decides not to align to the IVDR, then manufacturers need to prepare to handle whatever new challenges this will bring. If the Swiss Federal Council does decide to align with the IVDR, then how will this work in reality?

IVD manufacturers will need to monitor the situation closely, to ensure they are compliant prior to placing products onto the Swiss market.