There is a lack of implementation of the medical device regulations.

UM – 06/2022

For some time now, the medical device industry has been heavily critical of the Medical Device Regulation (MDR), which comes into force on 26 May 2021, and more recently of the In Vitro Diagnostics Regulation (IVDR). The obligation to recertify existing products on the market is particularly problematic. At the beginning of June, the German Hospital Federation (DKG), together with medical societies from the fields of surgery, cardiology, and paediatrics and adolescent medicine, also expressed concern about impending supply restrictions and called for regulatory relief in a letter to the EU Health Commissioner, Stella Kyriakides.

Supply bottlenecks have various reasons

The "Employment, Social Policy, Health and Consumer Affairs" Council (EPSCO Council) discussed medical devices on June 14. During an orientation debate, Kyriakides clarified that further delays, and thus the extension of transition periods are not an appropriate solution at this time. In December, the European Commission intends to provide further information on the state of affairs. At the European Council meeting, Germany called for an interim evaluation in December 2022 and July 2023 in order to be able to examine the necessity for further action at an early stage. The political decision also takes into account the fact that supply bottlenecks for medical devices can have very different causes.

Market adjustment is deliberate

Last but not least, the coronavirus pandemic continues to have an impact. Supply chains have been interrupted and have to be re-established in some cases. These are also partly economic decisions by companies to withdraw from the European market. One must reckon with the following: the new law is accompanied by a deliberate process of market adjustment. Moreover, key authorities for medical device certification are no longer available following Brexit. Their tasks must be performed by the so-called notified bodies in the EU.

Implementation is sluggish

This is indeed the eye of a needle. This is because Brexit comes at a time when notified bodies are undergoing an important reconfiguration process. Under the new law, these must guarantee a quality-assured certification process. There were major shortcomings here in the past. However, medical devices must first qualify themselves and be re-designated for the recertification of existing devices and the certification of new ones. As of June, only 30 notified bodies are working for the MDR and only seven for the IVDR under the new law. The Eudamed database for registration and identification of manufacturers and products is also not yet fully operational.

Sometimes, there is also a lack of good will

Nevertheless, part of the truth is: It is incomprehensible why recertification causes so many problems for high-performance existing devices. A position paper from the European Commission's Medical Device Coordination Group (MDCG) confirms: As of April 2022, 75 per cent of notified bodies reported that more than 50 per cent of the applications submitted were deemed incomplete. This illustrates the overall inadequate preparation of the manufacturers.

Transparency yes, sweeping criticism no

In view of the mixed situation, it would also be wrong, in the opinion of the German Social Insurance, to give in to pressure from the industry and change the new laws again. However, action must be taken where facts are presented and there is a real threat of gaps in supply. Transparency is needed for this, but not blanket threat scenarios.