Berlin: (hib/PK) The Union parliamentary group is calling for a sustainable strengthening of the healthcare industry. Medical devices make an important contribution to efficient healthcare and are at the same time an important economic and labor market factor, according to a motion (20/9735) by the parliamentary group.
More than 250,000 people were employed in the medical technology industry in Germany in 2022. Sales in the MedTech industry were around 38 billion euros that year.
The industry has been preparing for the EU Regulation 2017/745 Medical Device Regulation (MDR) for years. The costs of implementation are estimated at seven to ten billion euros. One of the main problems is the capacity bottlenecks at the so-called notified bodies, which must be included as part of the conformity assessment procedure.
In view of the difficult conditions, numerous companies have already decided to no longer plan products for recertification in Europe, but rather to withdraw them from the market or, alternatively, to approve them in the USA using a simpler procedure. As a result, the care of patients across Europe suffers.
In order to avoid bottlenecks in the supply of medical devices, the now changed MDR would give manufacturers up to four years more time to convert their products to the new regulation than originally planned by the EU Commission, the application continues. A postponement has been achieved until December 31, 2027 for higher-risk medical devices and for low-risk medical devices until December 31, 2028.
Among other things, the MPs are calling for an adjustment of the capacities of the notified bodies in order to promote rapid certification of medical devices. Furthermore, the reduction of bureaucracy in technical documentation must be promoted and greater efforts must be made towards digitalized processes. The five-year recertification, especially for product classes with lower risk, should be abolished, as the products are already under constant control by the notified bodies.