The European Medical Device Regulation (MDR) came into force in 2017 and its application by manufacturers within the EU has been mandatory since May 26, 2021. This has replaced decades of established processes for placing medical devices on the market and making them available.
Unfortunately, the MDR system has not been fully implemented to date and brings with it a number of negative consequences and challenges. The variety of medical devices in Europe threatens to become smaller and in some cases, alternative products will not be found on the market. This is the result of a joint survey by the Association of German Chambers of Industry and Commerce (DIHK), MedicalMountains GmbH and the industry association Spectaris.
In addition to the loss of existing products and the associated lack of patient care, it is also apparent that the innovation activities of companies in Europe are suffering massively. Almost every second company (46 percent) is currently having to put innovative projects on hold due to the MDR. One-fifth of the companies (19 percent) are now switching to other markets, such as the USA or Asia, for the initial approval of their medical technology innovations due to the MDR.
The biggest challenges for companies in implementing the MDR are a lack of capacity at notified bodies (66%) and high certification costs (58%). The unclear legal situation (46%) and the high financing costs of the required clinical studies (43%) are also not acceptable for many medical technology manufacturers.
The acute problem situation has now reached the awareness of the responsible political decision-makers at national and European level. How will the MDR construction site develop in the future?