Switzerland has taken a significant step in harmonising its regulations for in vitro diagnostic (IVD) medical devices with the EU. As of 1 January 2025, the updated transitional deadlines introduced under the EU’s In Vitro Diagnostic Regulation (IVDR), which were already formally incorporated into the country’s Ordinance on In Vitro Diagnostic Medical Devices (IvDO), have now started applying. This alignment, which follows a decision made on 20 November, is poised to ensure regulatory consistency and supply chain stability for legacy IVDs in Switzerland.
Tackling challenges in regulatory transition
The new timelines extend the validity of existing certificates issued under the older EU IVDD framework to the end of 2027, 2028, or 2029, depending on the classification of the devices. This adjustment is intended to ease the workload on regulatory bodies and certification authorities, which have struggled with capacity constraints during the transition to the new rules.
Additionally, Switzerland is planning to simplify labelling requirements for certain IVDs distributed by healthcare professionals. This adjustment, outlined in Article 87 of the IvDO, is expected to further facilitate the availability of diagnostic devices, ensuring a stable supply chain for the Swiss market.
Revised deadlines for compliance
Manufacturers aiming to sell legacy IVDs in Switzerland can benefit from the extended transitional periods, which are as follows:
- 31 December 2027 for as Class D and those previously certified under the IVDD.
- 31 December 2028 for Class C.
- 31 December 2029 for Class B and Class A sterile.
Strengthening EU-Swiss relations
This regulatory shift is occurring alongside broader developments in the relationship between Switzerland and the EU, with the publication of a Press Release on 20 December 2024. Recent discussions between European Commission President Ursula von der Leyen and Swiss President Viola Amherd have led to the conclusion of negotiations on a comprehensive agreement package. This milestone signals both parties’ commitment to closer collaboration across multiple sectors.
This move reflects Switzerland’s dedication to maintaining alignment with the EU in areas critical to public health and safety. As Switzerland and the EU work towards strengthening their partnership, the updates to legacy IVD regulations represent a key step in achieving greater consistency and efficiency in the region’s healthcare landscape.
For any questions on compliance of In-vitro devices in Switzerland! Contact us today.
Meric Gonul
Regulatory Intelligence & Innovation
15/01/2025
Reference:
Federal Council (2024), Adaptation de l’ordonnance sur les dispositifs médicaux de diagnostic in vitro et de l’ordonnance sur les dispositifs médicaux. Retrieved on 10.01.2025
SwissMedic (2024), Amendment of the Ordinance on In Vitro Diagnostic Medical Devices (IVDs) and the Medical Devices Ordinance. Retrieved on 10.01.2025
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