Amendment to the Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO) and the Medical Devices Ordinance: Update 2025
As of January 1, 2025, the amended Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO) comes into force, aligning with European Union (EU) regulations and restoring regulatory equivalence between Switzerland and the EU. This update has significant implications for medical device manufacturers and in vitro diagnostic (IVD) devices in the Swiss market and should be carefully considered by all healthcare institutions and companies in the sector.
Key Changes in the Updated IvDO and EU Regulations
The amendment is based on Regulation (EU) 2024/1860, adopted on June 13, 2024, which introduces essential changes to the EU-IVDR (EU In Vitro Diagnostic Medical Devices Regulation) and EU-MDR (EU Medical Devices Regulation). Some of the most notable changes include:
1. Extension of Validity for Medical Device Certificates
Certificates issued under the previous legislation in the EU will be extended until 2027, 2028, or 2029, depending on the risk class of the device, to address bottlenecks at notified bodies. This extension will help ensure the continuous supply of IVDs in Switzerland.
2. Simplification of Mandatory Labeling
A permanent simplification of mandatory labeling for professional-dispensed IVDs (Article 87 IvDO) has been planned. This change aims to facilitate access to the Swiss market and improve IVD availability.
3. Additional Time for Healthcare Institutions to Prove Equivalence
Healthcare institutions will have more time to prove that their in-house devices or laboratory-developed tests (LDTs) cannot be replaced by equivalent CE-marked devices on the market. This proof obligation will only come into effect on December 31, 2030, rather than on May 26, 2028, as initially stipulated.
4. Exclusion of the Obligation to Notify Supply Interruptions
Regulation (EU) 2024/1860 does not include the new notification obligation under Article 10a of EU-MDR and EU-IVDR, which requires manufacturers to notify interruptions or discontinuations in the supply of certain medical devices. This obligation is not part of this revision of the Swiss ordinances.
What Do These Updates Mean for Medical Device Manufacturers and Healthcare Businesses?
This reform regulates in vitro diagnostic medical devices (IVDs) in Switzerland more flexibly, aligning medical device regulations with EU standards. This is crucial for medical device manufacturers aiming to access the Swiss market, as regulatory equivalence facilitates trade and distribution of medical devices.
Furthermore, the device registration obligation already outlined in the Medical Devices Ordinance (MedDO) and IvDO will enter into force on July 1, 2026, six months after the expected registration obligation in EUDAMED. This means that businesses will have additional time to comply with the device registration requirements in EUDAMED and Switzerland, providing an opportunity for smoother transition.
How Will These Changes Affect Your Business?<
The new regulations on in vitro diagnostic devices and the IvDO provide manufacturers and distributors more time to adjust to regulatory changes and ensure compliance with the new rules. Staying informed about these updates is key to avoiding delays or disruptions in the distribution of your products in the Swiss market.
Stay Updated on the Latest Regulatory Changes!
If your company is involved in the distribution or manufacturing of in vitro diagnostic devices in Switzerland or Europe, staying informed about regulatory changes is crucial. Ensure your company meets the new IvDO and EU-IVDR requirements to avoid disruptions in product supply and remain competitive in the market.
Contact us today to learn more about how these changes may impact your business and how we can help you meet current regulatory requirements.
