In the meantime, the date of application of the MDR has been postponed by one year to May 2021. An amending regulation was adopted for the IVDR, which does not postpone the date of application, but does contain staggered transitional provisions. These measures are intended to ensure patient care even after the regulations come into force. However, the regulatory system (notified bodies, regulatory infrastructure, European database, reference laboratories, guidance documents, secondary legislation, etc.) is not yet set up in such a way that a smooth transition from the directives to the new regulations could take place. In addition, coping with the COVID-19 pandemic has absorbed a considerable amount of resources. The measures outlined above have resulted in a dynamic system that is subject to constant adaptation.
Manufacturers welcome the above amendments. Despite the changed timeframe, acute problems remain. There is an urgent need for action in order to guarantee the smooth implementation process and continue to ensure patient care.
1. expanding the capacity of notified bodies
Compared to the capacity of notified bodies under the previous directives, the current capacities under the MDR and IVDR are considerably lower. This is due, on the one hand, to the significantly lower number of notified bodies (for medical devices: just under 50%; for IVDs: just under 30%) and, on the other hand, to the significantly increased effort for tests and audits, the increased effort within shorter periods of time due to the transition periods and the greatly increased number of products for which the involvement of a notified body is required. Therefore
- the capacities of notified bodies must be massively expanded and the joint assessment procedure for new designations and reassessments must be accelerated,
- Incentives for new applications from notified bodies must be provided,
- All manufacturers have equal access to notified bodies.
2. targeted use of existing resources in the system
Parallel to the increase in capacities, the resources currently available must be used better and in a more targeted manner. Priorities should be set on QMS audits and the review of technical documentation under the MDR/IVDR. This can be implemented through the following measures:
- The depth of assessment is based on the class and novelty of a product.
- Bureaucratic hurdles for non-significant changes for legacy products must be removed. Pragmatic solutions must be found and implemented for scope extension audits and for the transfer of safe existing products that have been on the market for many years to the new regulations. This can be achieved by giving greater weight to post-market data, recognizing clinical practice and the principle of similarity, streamlining consultation processes and issuing certificates subject to conditions.
- Implementation aids such as MDCG guidance documents are subjected to an impact analysis to ensure that they do not represent an additional (bureaucratic) burden in the procedures.
- Harmonized and Europe-wide special regulations for niche products will be created.
3. bringing innovations to the market
The medical technology sector (MD and IVD) makes a significant contribution to healthcare in Germany through innovation. To date, around 10% of the industry's turnover has been invested in research and development. At present, it is extremely difficult to place new products on the market and manufacturers are unable to plan with any certainty.
For manufacturers without a notified body, market access for new products is blocked due to a lack of certification capacities for new products. Manufacturers with a notified body also face challenges: Due to the time-limited possibility of transferring existing products within the transition periods, resources on the part of manufacturers and notified bodies are currently being shifted to existing products in order to ensure the continued market availability of established therapies.
This also means that no resources are available for innovations. In order not to lose Europe as a location for innovation, we need a fast-track procedure for innovations.
4 MDR: Postponement of the transition period
More time is needed to implement the above-mentioned solutions and prepare the system, e.g. by extending the deadline to May 26, 2024 and/or the validity of the directive certificates and/or by removing the end date of May 26, 2025 for the "sell-off" of directive devices already placed on the market.
5 IVDR: Class D devices and companion diagnostics
Under the amending Regulation (EU) 2022/112, future high-risk Class D devices have been given the shortest transitional period until May 2025. However, these products must undergo the longest (16-24 months) conformity assessment procedure. Many manufacturers do not yet have a notified body and the required reference laboratories have not yet been designated. Similar problems arise with companion diagnostics, for which the EMA is mandatory in the conformity assessment process, but the process is not yet established. If the discrepancy between the shortest transition period and the longest conformity assessment procedure is not resolved, the safety of patient care cannot be guaranteed.