DIMDI and BfArM merged. Now it is BfArM!
"The Federal Institute for Drugs and Medical Devices (BfArM) and major functional units of the German Institute for Medical Documentation and Information (DIMDI) were merged into one authority under the auspices of the BfArM on 26 May 2020." To the full article.
DIMDI (abbreviation for Deutsches Institut für Medizinische Dokumentation und Information, in English German Institute for Medical Documentation and Information) developed the Medical Devices Information System ‐ the database through which notifications of medical devices are submitted with the competent authorities in the different German federal states; it also provides input for the European Database on Medical Devices (EUDAMED).
As of now, MDSS has not encountered any differences in regards to the registration of products. However, they may come along as soon BfArM may evaluate their own needs.
In addition to that BfArMs role has changed under the new German Medical Device law.
The merge is an important information since the registration as required by the MDR in Eudamed is not working yet for another 2 years and, therefore, the current registration according to the MDD is still in place and mandated. Let's hope BfArM will not change the registration requirements on us during this time.
The MDR provides for this fall back scenario, until Eudamed is fully functional, in Article 120 3 (d) last bullet point and Article 122. This means your Authorized representative will have to perform the product registration as it is required under the MDD rules for products, which are already fully compliant to the MDR and also certainly for the product, which are allowed to follow the MDD according to article 120, the commonly called legacy devices.
The transition plan has somewhat changed that member states want to implement Eudamed modules as soon as they become available and apparently will ask manufacturers to voluntarily submit their data to the respective module even though the Eudamed is not fully functional. The notified bodies may require the use of Eudamed since certain modules may make their lives easier.
This approach has some significant disadvantages.
- Some modules should actually be connected and the functionality may be impaired due to the other modules missing. Eudamed is not only a storage place for the data, it also a place which provides procedural aspects.
- We assume even though you may voluntarily enter the product data into Eudamed, we still may have to perform the national registrations according to the MDD since it is not “mandated” yet.
Certainly MDSS will monitor these disturbing developments for you. Please inform us if you become aware of any different information.
One last thing: Recently we were confronted with the new meaning for the MDR abbreviation – Most Difficult Regulation
Good luck with the MDR implementation and as always stay healthy.