Helping MedTech innovators navigate a river of regulation
MedTech SMEs provide over 650 000 jobs in Europe and their sector is responsible for the highest number of patent applications. They contribute over EUR 14 billion to the EU economy and are a major source of innovation, economic strength and product diversity. They are a vital industry to nurture, especially when considering Europe’s ageing demographics. However, the EU’s new medical device regulations have substantially increased the regulatory burden on SMEs and threaten the competitiveness of the European SMEs pioneering the next generation of medical devices. Under the Medical Device Regulation (MDR), all new and existing medical devices need to undergo reassessment of their risk class, and require more comprehensive documentation and increased clinical testing. The EU-funded MDOT (Medical Device Obligations Taskforce) project was launched in January 2019 to help SMEs navigate these new requirements, to ensure that they are fully compliant, whilst preserving the sector’s economic well-being and long-term ability to innovate.
A dedicated platform to ensure compliance and patient safety
In particular, the project is supporting SMEs with their mandatory conformity assessment requirements through the design and establishment of a data platform that is specifically tailored to the regulatory needs of MedTech SMEs. The idea is to create a platform that is both affordable and simple to use, and provides easy access to medical device testing data in a secure and transparent environment. Alongside this, MDOT will perform joint evaluations of commonly used parts and devices, further reducing complexity and individual costs to SMEs. To demonstrate the usability of MDOT’s platform, the project is addressing three specific technologies as a starting point: inhalation technology (specifically inhalers for pre- and early-term neonates), 3D-printed active neural implants, and coatings for orthopaedic prostheses. For these three chosen technologies, demonstrator test beds are being developed and upgraded to ensure the long-term safety and long-term stability of devices and materials. Eventually, the aim is for device innovations to reach the clinical trials stage (TRLs 4-7). The project aims at eventually expanding the platform to cover all medical device sectors. Overall, project partners envision their platform as a ‘meta-network’ that will tick crucial boxes to guarantee the future of Europe’s MedTech sector, safeguarding innovation and economic vigour, limiting animal testing (through joint actions) and supporting the MDR’s overall objective of enhancing patient safety. MDOT involves 13 consortium partners across seven European countries. The project is due for completion in December 2023 and has received nearly EUR 8.5 million in EU funding.
Keywords
MDOT, Medical Device Regulation, SMEs, medical device, conformity assessment, regulation