Two years have passed since the introduction of the German Medical Device Law Amend-ment (21.03.2010). This was a major legal change that re-shaped the German regulatory me-dical device landscape on many levels. Before that, starting a clinical study in Germany re-quired only an Ethics Committee approval and a relatively simple local authority notification.
Since 31st March 2010, the regulatory process leading to the start of a new medical device study had to follow the new approval process, whereby BFARM played a major role. The new law, together with related ordinance (MPKPV. 13.05.2010), has defined the Ethical Commit-tee and Competent Authority approval process, and set up a new dimension of stringency on both formal and content levels. These new requirements have challenged not only medical device manufacturers and CROs, but also, the Ethics Committees and Competent Authorities themselves.
Two (2) years after the new law was implemented, BFARM took an opportunity to organize the Bonn Meeting. Its major focus was to share the related experiences of all involved stake-holders, facilitate dialog between them in order to bring more clarity, and raise issues impor-tant to stakeholders. In the end it will create solutions that will make starting of medical de-vice studies a faster and smoother process.
Detailed aspects of the approval process, challenges in differentiation between medical de-vices and other medical products, subtleties of regional and national regulations as well as various compliance topics, were presented and discussed.
One of the Bonn Meeting’s messages was that since 2011,BFARM has approved 500 studies and has granted waivers for more than 150 studies, emphasizing that that despite of the new regulatory challenges, Germany is still the number one choice for performing medical device studies. This was additionally confirmed by the EU wide statistics presented, where Germany was the most popular choice for Medical Device clinical studies. As many as 28% of studies were organized with participation of German investigational sites, a result that leaves any other EU country far behind.
One of the key take home messages that we would like to quote here – were the most com-monly encountered formal deficiencies in the applications for BfArM approval.
The guidelines on how to avoid these deficiencies were also provided. They are as follows:
Next, we draw your attention to additional useful information from this meeting and from the recently published article "Approval process of clinical studies with medical devices" (Fischer et al. Bundesgesundheitsbl. 2012, 55:270-276). We already shared with you the typical shortcomings on the formal level encountered in the BFARM applications for approval and the ways to prevent them. Now we will quote BFARM`s experience on their most frequently observed shortcomings in medical device study applications as far as the content is concerned.
These shortcomings are as follows:
BFARM suggests how to prevent these shortcomings:
In case of certain low risks medical device trials (for more information please see Section 20 of the German Act on Medical Devices) BFARM can waive the authorization. Applications for such waivers although very much simplified as compared to the standard authorization process still pose certain difficulties to the applicants. Therefore, a short summary of waiving applications shortcomings was presented as well.
These shortcomings are:
As previously it is advised how to avoid these shortcomings:
Finally in both the above mentioned article as well as during the meeting, BFARM emphasized its efforts to conduct the application review process in a cooperative and partnership based fashion. It was also made clear that BFARM personnel are easily available by phone and email for specific questions and advice. Our CRO experiences confirm that and we highly recommend searching for specific assistance before and after the application has been done.
By doing so, the applicants assure maximum compliance with BFARM requirements. Moreover, BFARM can offer scientific advice services focusing on specific issues related to device development processes as well as the clinical trial design well before the application for authorization is complete. This is especially recommended in case of combination products (device with medicinal product) and highly innovative medical devices.