Brainlab AG
Brainlab is a digital medical technology pioneer.
ID: 376840541621-79
Lobbying Activity
Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation
21 Mar 2025
We are a medical device manufacturer of classes I, Is, Ir, IIa, IIb and III based in Germany. We have multiple MDR certificates and many product codes to maintain under MDR. While it was a long way to receive all these codes and a big investment to maintain the EU market access, we still struggle with constantly changing rules and interpretations of the new EU MDR, high costs, and long certification times. 1) Time to market delays Long lead times at the Notified Body (NB) e.g. for reviewing change notifications, receiving feedback, issuing of new certificates, result in Technical Documentation (TD) assessment projects lasting over a year and constantly changing, and thus, delaying product releases at the manufacturers. When multiple changes to the same certificate are running concurrently at the NB, a problem in one TD assessment project delays issuing the certificate for other changes and delays product releases at the manufacturers. Currently, there is a minimum 3-month wait to receive an updated certificate from the NB once the TD assessment project is completed. 2) High costs of certifications and maintenance High fees (certification costs) and long lead times (for certificates, for audit planning and closure, for change notifications, etc.) are problematic. We would like to suggest time-boxed reviews and services from the NB, similar to the approach used by the FDA. Cumbersome and redundant documentation requirements, such as manual and time-consuming completion of checklists or overview files (Appendix ABC) results in high maintenance and administrative costs for the manufacturers. In case of findings/ deficiencies, additional invoices are created for review. Basically, the business model is that more findings lead to more revenue of the NBs. Increased requirements for clinical investigations lead to more bureaucratic overhead. 3) Unclear requirements and interpretation of EU MDR requirements The interpretation of requirements is unclear and/or changing (e.g., product MDCG guidance translates and explains the EU MDR requirements, potentially introducing new concepts and/or new requirements). The guidance is essentially equivalent to a standard or the EU MDR itself. The new classification rules, in particular for software, did up-classify a lot of devices. Rule 11 (software) hardly makes it possible to release a class I software medical device. This significantly increases costs, e.g. for certification, as well as the time to market. Repeated efforts as changes (e.g. new versions) have to go through similar activities. The definition of "critical suppliers" has been expanded to include service providers that are not considered to significantly influence the conformity the device by the manufacturer. This includes regulatory representatives and certain testing laboratories. ZLG and Certification Bodies have increased their focus on ensuring that NBs maintain a high standard of transparency, which has resulted in additional regulatory requirements, especially in the administrative area. However, there is a lack of evidence that these measures have led to an improvement in patient safety. Many NBs have been overwhelmed by the increased demand for assessments and audits since the MDR came into effect. Some NBs are already at full capacity with existing clients, and they may have limited availability to onboard new clients, especially for high-risk devices that require more in-depth evaluations. As a result, manufacturers who are dissatisfied with their current Notified Body may find it difficult to make changes. New product codes (EMDN) were created without advance notice or information on changes by EU. The NB expects manufacturers to use the most appropriate code, and a comprehensive streamlined approach by NBs to when and how to modify existing codes should be considered.
Read full responseMeeting with Manfred Weber (Member of the European Parliament)
27 Jan 2025 · Politischer Austausch/Betriebsbesuch
Meeting with Gabriele Bischoff (Member of the European Parliament, Shadow rapporteur) and Bayer AG and
24 Jan 2025 · Austausch mit dem Wirtschaftsforum der SPD e.V. zur Revision Eurobetriebsräte
Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur)
23 Jan 2024 · EHDS