IvDO Update 2025: Key Changes in Swiss In Vitro Diagnostic Regulations
As of January 1, 2025, the amended Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO) will take effect, aligning with European Union (EU) regulations and restoring regulatory equivalence between Switzerland and the EU. This update significantly impacts IVD manufacturers and healthcare institutions operating in the Swiss market, making compliance essential for all industry players.
Key Changes in the Updated IvDO and EU Regulations
The IvDO amendment is based on Regulation (EU) 2024/1860, adopted on June 13, 2024, which introduces major updates to the EU-IVDR (In Vitro Diagnostic Regulation) and EU-MDR (Medical Devices Regulation). The most notable changes include:
1. Extended Validity for Medical Device Certificates
Certificates issued under previous EU regulations will be extended until 2027, 2028, or 2029, depending on device risk classification. This extension addresses bottlenecks at notified bodies and ensures the uninterrupted supply of IVDs in Switzerland.
2. Simplified Labeling Requirements for IVDs
The new IvDO regulation introduces permanent simplifications in mandatory labeling for professionally dispensed IVDs (Article 87 IvDO). These changes streamline market entry and enhance IVD availability in Switzerland.
3. Additional Time for Healthcare Institutions to Prove Equivalence
Healthcare institutions now have until December 31, 2030, to demonstrate that in-house laboratory-developed tests (LDTs) cannot be replaced by CE-marked devices. This extends the compliance deadline beyond the initial requirement of May 26, 2028.
4. Removal of Supply Interruption Notification Obligations
Unlike EU-IVDR and EU-MDR, Regulation (EU) 2024/1860 does not include Article 10a, which mandates manufacturers to notify supply disruptions. This revision reduces regulatory burdens on IVD manufacturers in Switzerland.
What Do These IvDO Updates Mean for Your Business?
The IvDO reform enhances regulatory flexibility for in vitro diagnostic devices (IVDs) in Switzerland, ensuring alignment with EU standards. This is critical for IVD manufacturers aiming to expand into the Swiss market, as regulatory equivalence facilitates trade and distribution.
Additionally, the medical device registration obligation under MedDO and IvDO will come into effect on July 1, 2026, six months after the expected EUDAMED registration deadline. This transition period provides companies extra time to meet compliance requirements in both Switzerland and the EU.
How Will the IvDO Changes Affect Your Business?
The new IvDO regulation grants manufacturers and distributors more time to adjust, ensuring seamless regulatory compliance. Staying updated on these IvDO changes is key to avoiding delays or disruptions in product distribution within the Swiss market.
Stay Compliant with the Latest IvDO Regulations!
If your company is involved in IVD manufacturing or distribution in Switzerland or the EU, staying informed on IvDO updates is essential. Ensure compliance with the new IvDO and EU-IVDR regulations to maintain market competitiveness and prevent supply chain disruptions.
📩 Contact us today to learn how these IvDO updates may impact your business and how we can help you navigate the new Swiss medical device regulations efficiently.
