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IVDR
The IVDR, which came into effect on May 26, 2022, introduced significant changes and more stringent regulations for in vitro diagnostic devices. These changes aim to enhance patient safety, improve the reliability of diagnostic results, and strengthen the overall regulatory framework. However, they have also presented unique difficulties for startups, particularly those based in Switzerland
One of the primary challenges for Swiss startups is the requirement for conformity assessment by a Notified Body. Under the IVDR, medical device manufacturers must obtain a valid certificate from a Notified Body to demonstrate compliance with the regulation. However, the number of Notified Bodies designated under the new regulation is limited, and many are located outside Switzerland. This geographical constraint can result in longer lead times, increased costs, and potential logistical complexities for Swiss startups seeking certification.
Furthermore, the IVDR places greater emphasis on clinical evidence and performance evaluation for in vitro diagnostic devices. Startups are now required to provide robust clinical data to support the safety and effectiveness of their products. This can pose a significant hurdle for early-stage companies with limited resources and research capabilities, as conducting clinical studies can be time-consuming, expensive, and technically challenging.
Another key concern is the increased scrutiny on post-market surveillance and vigilance. The IVDR requires manufacturers to establish systems for monitoring the performance and safety of their devices throughout their lifecycle. Startups may struggle to allocate adequate resources to meet these new post-market surveillance requirements, especially if they are operating on a limited budget and have limited experience in this area.
Swiss manufacturers also face the requirement of appointing an Authorized Representative (EC Rep) within the European Union (EU). According to the IVDR, manufacturers based outside the EU, including Switzerland, must designate an Authorized Representative established within the EU to act as a point of contact with regulatory authorities.
Additionally, the IVDR’s complex classification system may pose challenges for Swiss startups. The new classification rules under the regulation are more comprehensive and encompass a broader range of devices. Determining the correct classification for a product can be a complex task, and misclassification can have significant implications for regulatory compliance and market access.
Lastly, the transition period provided by the IVDR is limited, and compliance deadlines are approaching. Swiss startups must swiftly adapt their operations and quality systems to meet the new requirements, which may require substantial investments in time, resources, and expertise.
To overcome these difficulties, Swiss in vitro diagnostic medical device startups should seek early regulatory guidance and engage with experienced consultants or regulatory experts who can provide guidance on the IVDR requirements and help navigate the certification process. Collaboration with research institutions, clinical experts, and strategic partners can also be beneficial in terms of clinical data generation and post-market surveillance activities.
While the IVDR poses significant challenges for Swiss startups, it is essential to recognize that the regulation aims to ensure patient safety and the quality of diagnostic devices. By proactively addressing these difficulties and investing in compliance, Swiss startups can enhance their competitiveness and access the vast European market for in vitro diagnostic medical devices.”