“Do we have the right balance between risk and patient benefit?”

Does the introduction of MDR and IVDR mean that we risk losing important medical technology innovations? Do the tightened rules make the certification process so complex that start-up companies simply do not participate and give up, with the result that important innovations that can improve care never reach the market? What can we do in the short term to avoid this happening?

European and Swedish authorities are working purposefully to promote entrepreneurship in the Life Science business. It is quite a considerable amount of money that is invested in various incubators and business parks with the aim of making it easier for researchers and other people working at universities or hospitals to develop and commercialize new innovative solutions in healthcare.

At the same time, new and more extensive regulations for medical devices have been adopted within the EU with the introduction of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR). The new requirements, however, require a significantly greater work effort from the companies to be able to certify both old and new products compared to the previous MDD and IVDD. The greatly increased requirements even make companies consider standing outside the EU and the MDR in order to invest in the US instead, where the certification process is simpler, the requirements are clearer and the authority FDA offers templates and instructions that make the process more transparent.

The question is whether the new regulations are at the right level or have we created a situation where, in our zeal to minimize risk, we have made it difficult for companies to launch their products so much that many simply give up and good innovations are failed due to an overcomplicated regulatory process? It is never possible to completely eliminate risks when treating sick patients. The primary thing in healthcare operations is to cure and alleviate with a reasonable level of risk.

In practice, it is not about completely eliminating risks, but it is about managing risks so that they do not exceed the potential benefit a product or innovation makes for the patient.

In practice, it is not about completely eliminating risks (although that would be desirable), but it is about managing risks so that they do not exceed the potential benefit a product or innovation makes for the patient. The question is whether we have found the right balance in the system or whether we have placed too much emphasis on risk minimization and control in relation to possible patient benefit?

However, it is a matter of developing new safe products that can quickly benefit the patient. Of course, we must not skimp on safety, but we must make it easier for companies to launch their products on the market. Here we have to work from two directions. On the one hand, the notified bodies should be given the opportunity to work more supportively to the companies to avoid them ending up in dead ends and having to redo a large part of the work, and on the other hand, responsible authorities must be given opportunities to guide and train the companies in how to carry out the certification process. Better support for SMEs to maneuver over the regulatory threshold means that innovations reach the market and can benefit patients sooner.

Mats Högberg, Director MedTech/IVD RegSmart Life Sciences

Column written for Med Tech Sweden, October 2023

Photo: Piret Ilver, Unsplash