The European Union's new medical device regulations (MDR) and in vitro diagnostic regulations (IVDR) have faced significant criticism from the industry. Many companies, especially smaller ones, find these rules overly complex and burdensome, hindering innovation and market access. Stakeholders have highlighted issues ranging from financial strain to impractical legacy device recertification requirements. The European Commission is evaluating the effectiveness of these regulations and may propose changes to alleviate some of the challenges.

Small Companies Face Financial and Operational Challenges

Smaller medical technology firms are struggling to comply with the stringent requirements of MDR and IVDR. These regulations impose substantial financial and administrative burdens that disproportionately affect startups and small enterprises. For instance, a U.S.-based company has had to halt the marketing of a life-saving device due to the financial strain imposed by MDR. Similarly, a two-person startup in the EU abandoned its clinically proven digital tool because compliance was deemed unfeasible.

Many small organizations are urging policymakers to reconsider and revise these regulations, which they believe are stifling innovation and driving startups out of the market before they can succeed. Some companies have proposed solutions, such as creating a more streamlined certification process focused on core standards. This approach would allow for more targeted evaluations, ensuring devices meet their intended functions without excessive paperwork. Others have suggested establishing a breakthrough pathway similar to the FDA’s program to accelerate review processes and provide regulatory assistance programs tailored for startups.

Critical Feedback on In Vitro Diagnostic Regulations

The IVDR has been particularly criticized for making it financially unviable for small and medium-sized companies to bring innovative diagnostic tools to market. Several organizations, including Dutch hospitals, argue that the old IVD directive was sufficient and that the new regulations address a non-existent problem. They contend that IVDR has created significant obstacles, particularly for smaller players, leading to a market dominated by large multinational corporations.

Further criticism has emerged regarding the treatment of legacy devices under IVDR. Many companies question the need to completely recertify devices with established safety records, arguing that this approach is disproportionate. Instead, they suggest focusing on post-market surveillance and vigilance data to ensure patient safety while reducing regulatory burdens. The European Commission is accepting feedback until March 21 and may propose changes to simplify procedures and reduce the burden on manufacturers. Potential implementing acts could be introduced as early as the first quarter of 2025 to address some of these concerns.