Regulatory Alignment Between the EU and Switzerland in In Vitro Diagnostic Medical Devices
On August 14, 2024, Swissmedic, Switzerland’s regulatory authority for therapeutic products, announced its decision to implement the recent amendment to the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR). This move aims to ensure the stability of in vitro diagnostic (IVD) medical device supplies in Switzerland as both regulatory frameworks adapt during the transition phase.
Context of the EU Amendment
On June 13, 2024, the European Union adopted Regulation (EU) 2024/1860, introducing significant modifications to the IVDR, particularly regarding transitional provisions for certain in vitro diagnostic medical devices. This change was necessitated by bottlenecks observed in notified bodies responsible for assessing and certifying these devices under the new regulatory regime. One of the key measures includes extending the validity of certificates issued under the previous legislation until 2027, 2028, or 2029, depending on the device classification.
Impact on Switzerland and Adopted Measures
Switzerland, although not an EU member, closely follows European regulations on medical products to maintain access to these markets and ensure a similar level of safety and efficacy. In this regard, Swissmedic has stated that the modifications introduced in the EU must also be applied in Switzerland to avoid potential disruptions in the supply of medical devices. This includes extending the validity of certificates for IVD devices whose certificates were issued under Directive 98/79 EC (IVDD) and have expired or are nearing expiration.
Swissmedic has confirmed that it will tolerate these certificate extensions in line with the new EU-IVDR provisions. For the effective implementation of these measures, Swissmedic will rely on the relevant EU interpretative documents, ensuring consistency with European regulations.
Next Steps and Regulatory Adjustments in Switzerland
It is expected that by fall 2024, Switzerland will make adjustments to its In Vitro Diagnostic Medical Devices Ordinance (IvDO) and Medical Devices Ordinance (MedDO) to fully align with the recent EU modifications. Additionally, in 2026, Switzerland will enforce the product registration requirements already established in these regulations, further reinforcing Swissmedic’s commitment to market surveillance and safety.
Swissmedic has reiterated its responsibility for monitoring the Swiss market and its ability to take corrective measures at any time if necessary to protect public health.
Conclusion
Aligning Swiss regulations with European ones is an essential step to maintaining the stability of in vitro diagnostic medical device supplies in Switzerland. This measure not only facilitates access to the European market but also ensures that patients in Switzerland continue to benefit from safe and effective devices during this period of regulatory transition.
