Switzerland: the ivDO amended to adapt to the extension of European transitional provisions & future developments!

The Swiss Ordinance on in vitro diagnostic medical devices (IvDO) was amended by Federal Council Decision RO 2024 741 of 20 November 2024 (link in French), which came into force on 1 January 2025.

So what are the changes brought about by this revision at the start of the new year?

The main change comes as no surprise. It is the extension of the transitional provisions for IVDs, based on the amending European Regulation (EU) 2024/1860, in order to guarantee equivalence with the EU (Articles 81 and 82 IvDO).

It’s easy to imagine that the European transitional provisions will be a distant memory after these festive times, so here’s a quick summary:

• • • Devices with a valid certificate may be placed on the market or put into service until 31 December 2027;
    • Devices whose conformity could, under the old law, be assessed without the intervention of a designated body, for which a declaration of conformity was drawn up before 26 May 2022 and for which the conformity assessment procedure requires, under the revised IvDO, the intervention of a designated body, may be placed on the market or put into service:
      • • until 31 December 2027 for Class D devices,
        • until 31 December 2028 for class C devices,
        • until 31 December 2029, for class B devices
        • until 31 December 2029, for class A devices placed on the market in a sterile state.

Other changes have also been introduced that are not linked to European equivalence:

• • • Continuation of the relaxation of labelling requirements (Article 15(9) IvDO): For devices that are not intended for self-diagnosis and that are placed on the market in accordance with the new law, information relating to the authorised representative may be affixed to a document accompanying the device, for an unlimited period.
    • Postponement of the entry into force of the obligation to provide evidence that devices manufactured and used in-house by healthcare establishments are not replaceable by comparable devices available on the market until 31 December 2030, instead of 26 May 2028 (Article 83b IvDO).

And that’s all there is to it.

As you may have noticed, the revision of the IvDO does not cover the new obligation to provide information under Article 10a of the European MD and IVD Regulations, which requires manufacturers to declare any interruption or cessation of the supply of certain medical devices. It would seem that before Switzerland follows suit, it is waiting for clear implementation arrangements at EU level.

What’s planned for the IvDO in the future?

The IvDO will shortly be amended again by Federal Council Decision RO 2024 742 of 20 November 2024 (link in French), which will come into force on 1 July 2026.

On this date, registration of devices with Swissmedic will become compulsory, except for devices placed on the market from 1 July 2026, which may be registered until 31 December 2026 (Art 90(2 and 2 bis) IvDO).

To stop experiencing MD/IVD regulations as a burden:

• • • • Webinar replays
      • Podcast
      • Other articles on regulatory trends