The EU project to streamline bureaucracy in medical technologies

Medical technology (MedTech) is a thriving sector in Europe. Just considering small and medium-sized enterprises, over 650 thousand people are employed in this sector, for a commercial surplus of over 14 billion euros.

However, the bureaucratic obstacles are pushing many of these companies to turn to other markets. This is mainly due to a particularly long and complex regulatory approval system, which has its origins in European Union Medical Devices Regulationwhich came into force in 2021, which increased the time and costs needed to bring new devices to the continental market.

“Generally speaking, European SMEs operating in MedTech are facing many difficulties in transitioning to the new Medical Devices Regulation, given its demanding requirements in terms of documentation and testing. And to all this are added the consequences of the Covid-19 pandemic.” This is what he says Ulrich Froriep, deputy director of the Division of Translational Biomedical Engineering at the Fraunhofer Institute for Toxicology and Experimental Medicine.

Among the solutions implemented to make the European market more attractive, theUe financed the progetto Mdot (Medical Device Obligations Taskforce)of which he is the coordinator Ulrich Froriep. The project was established to help accelerate the adaptation of small and medium-sized businesses to new regulations, while simultaneously improving the quality of medical devices. In this way, the European SMEs will be able to more quickly and easily obtain regulatory approval for their new products.

“In a nutshell,” he explains Froriep“MDOT’s purpose is to update testing facilities and facilitate awareness of regulatory requirements, as well as develop appropriate testing methodologies to prevent the loss of MedTech innovation and economic strength in Europe.”

Companies will therefore be able to rely on a network of specialized partners and research institutes across the continent, together with clinical evaluation experts, testing facilities and ongoing regulatory advice, thus finding concrete support throughout the entire process. “We approach the MedTech value chain from all relevant angles,” he further states Froriep.

The platform, which offers a single point of access for those companies in the sector that intend to introduce new products on the market, is aimed in particular at fields of prosthetics and inhalation. As an example, we can cite one of the projects in progress, aimed at the administration of inhaled drugs for premature babies: the technology in question, created by a partner of Mdot, was tested thanks to a specific test developed together with a second partner, while a third partner will take care of the clinical trials. All this occurred with the support of constant regulatory consultancy. Thanks to the success of this operation, the Mdot team is evaluating the possibility of creating a start-up to commercialize the technology.

In the end, The MDOT project has also developed a vast database in the medical field, which includes large libraries of medical literature and jurisprudence, not only European, relating to the sector. Again, the goal is to provide an additional resource to those companies hoping to gain regulatory approval for their products.