MedTech Europe is outlining the obstacles that medical technologies encounter within the European regulatory framework.
According to the latest information, there are more than 35,000 medical technology companies in Europe, with 92% of them being small and medium-sized enterprises (SMEs). These companies currently offer approximately 500,000 medical technologies to European patients. It is anticipated that at least 17% of current In Vitro Diagnostics (IVDs) and 20% of Medical Device (MD) portfolios will be discontinued in Europe. This is attributed to the expectation that the costs associated with transitioning to the In Vitro Diagnostic Regulation (IVDR) or Medical Device Regulation (MDR) will outweigh product revenue, particularly for SMEs. Additionally, 28% of In Vitro Diagnostic (IVD) manufacturers and 48% of medical device manufacturers are either deprioritizing or planning to deprioritize the EU market as their first choice for regulatory clearance due to these challenges.
The position paper presents a three-point vision for what a prospective system could resemble. This vision is accompanied by suggested solutions to initiate discussions among all affected parties regarding the necessary changes to improve the current system.
In the face of evolving regulatory challenges for medical technology companies in Europe, our specialized services are tailored to provide comprehensive assistance, guiding businesses through the intricacies of compliance with the MDR and IVDR.
Contact us to ensure a smooth transition, and let our expertise support your journey towards regulatory success.