In Germany, the Medical Device Implementing Act (MPDG) is applicable. Currently, the manufacturer based in Germany, or their Authorized Representative (EC Rep) for manufacturers located outside the EU, is responsible for product registration in the DMIDS (German Medical Devices Information and Database System) in accordance with MPDG §96(1).
Under the previous Medical Devices Act (MPG), the importer also had to register imported products in advance. This obligation has now been removed since the importer is not equivalent to the former German importer (“Einführer”) according to the Medical Devices Act (MPG). The importer according to the MPG was rather a unique German requirement. Importers under Regulation (EU) 2017/745 or Regulation (EU) 2017/746, unlike the importer under the MPG, do not have an obligation to register products, either in EUDAMED or in the national DMIDS database (except in cases as defined by Article 16 of Regulation (EU) 2017/745 or Regulation (EU) 2017/746). Importers, however, like manufacturers, authorized representatives, and manufacturers of systems/treatment units, must register as economic operators in EUDAMED (according to Article 30, 31 of Regulation (EU) 2017/745 or Article 27, 28 of Regulation (EU) 2017/746).
Once EUDAMED is fully functional, regardless of their location, the manufacturer will be responsible for product registration in EUDAMED (as per Article 29 of Regulation (EU) 2017/745 or Article 26 of Regulation (EU) 2017/746). Based on the current status of EUDAMED, mandatory product registration in EUDAMED is expected to commence no earlier than Q2 - 2029.
Currently, product registration in EUDAMED is already possible on a voluntary basis. However, this does not replace existing national notification obligations, which must be fulfilled in Germany through DMIDS.
If you have questions about registration in EUDAMED, whether as an economic operator or in terms of pure product registration, please feel free to reach out to us. We are here to provide advisory support at any time.