Use of cookies
Cookies help us to provide our services. By using our website you agree that we can use cookies. Read more about our Privacy Policy and visit the following link: Privacy Policy (only in German)
Reporting channels according to MDR, IVDR and MPDG
Notifications, applications and reports according to Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR)
Pursuant to the notices in the Federal Gazette:
- notice under § 97 para. 1 sentence 2 and para. 2 of the Medical Device Law Implementing Act ("Medizinprodukterecht-Durchführungsgesetz", MPDG) governing the transitional period until the European Database on Medical Devices is fully operational in accordance with Article 33 of Regulation (EU) 2017/745
Reference: BAnz AT 28.05.2021 B6 - notice under § 96a para. 3 and 97a para. 1 sentence 2 and para. 2 of the Medical Device Law Implementing Act governing the transitional period until the European Database on Medical Devices is fully operational in accordance with Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746
Reference: BAnz AT 27.05.2022 B4
| MDR | IVDR | Obligatory notification/application/report | Fulfillment of the obligation until EUDAMED is fully functional |
|---|---|---|---|
| Art. 29 and Art. 22 para. 1 and 3 | Art. 26 | Registration of devices as well as of systems and treatment units in the UDI database | Via DMIDS (also: §§ 96 para. 1 and 96a para. 1 MPDG) |
| Art. 31 | Art. 28 | Registration of manufacturers, authorised representatives and importers | Via EUDAMED, "Actor Registration" module |
| Art. 56 para. 5 | Art. 51 | Registration of certificates issued by Notified Bodies including amendments, limitations, supplements as well as on suspended, re-instated, revoked or refused certificates | Via DMIDS (also: §§ 96 para. 2 and 96a para. 2 MPDG) |
| Art. 70 and 82 | Art. 66 | Applications for clinical investigations/notifications for other clinical investigations; applications for performance studies | Via DMIDS |
| Art. 74 | Art. 70 | Applications for relevant clinical investigations of CE-marked devices | Via DMIDS |
| Art. 75 | Art. 71 | Notification of intended substantial and other changes to clinical investigations/other clinical investigations | Via DMIDS |
| Art. 77 | Art. 73 | Information on the temporary suspension or termination of a clinical investigation; final report of the clinical investigation and summary | Via DMIDS |
| Art. 80 para. 2, 3 and 6 | Art. 76 | Reporting of adverse events in the context of a clinical investigation | Using the linked forms via e-mail to mpsae@bfarm.de |
| Art. 87 para. 1, 8 or 9 | Art. 82 | Reporting of serious incidents and field safety corrective actions | Using the forms linked below via web application or e-mail to mp-vigilanz@bfarm.de Reporting serious incidents: Reporting field safety corrective actions: |
| Art. 88 para. 1 | Art. 83 | Reporting trends | Informally via e-mail to mp-vigilanz@bfarm.de |
| Art. 89 para. 5 and 8 | Art. 84 | Manufacturer's final report, field safety corrective action | Using the linked forms (information under "Section 4: Manufacturer analysis" on the final report) or informally (field safety corrective action) via e-mail to |
Notifications, applications and reports pursuant to the Medical Device Law Implementing Act (MPDG)
| MPDG | Obligatory notification/application/report | Fulfillment of the obligation until DMIDS is fully functional |
|---|---|---|
| Notifications according to § 4 | Supplementary notification obligations | Entry via DMIDS, module "Address Notifications" See also: DMIDS - Notifications |
| Applications and decisions according to § 6 para. 2 | Legal status and classification of products | Via e-mail to mp-klar@bfarm.de See also: Classification |
| Applications and decisions according to § 6 para. 3 | Applications for decisions on the authorisation of clinical investigations or performance studies | Via e-mail to mpkp@bfarm.de See also: Application for decision on requirement for approval |
| Applications according to § 7 | Applications for special approvals | Using the form linked below, by e-mail to mp-sonderzulassung@bfarm.de |
| Applications and notifications according to Chapter 4 | Applications for and notifications of clinical investigations and performance studies | Via DMIDS, module "Klinische Prüfungen und Leistungsstudien" See also: DMIDS - Clinical Investigations and Performance Studies |
| Applications and notifications according to Chapter 4, here: § 64 | SAE reports | Using the linked forms by e-mail to mpsae@bfarm.de |
| Notifications according to § 81 no. 1 | Product associated hazards (distributors, importers) | Via web application: Online form for notifications by users and patients pursuant to MPAMIV Or using the form linked below via e-mail to mp-vigilanz@bfarm.de Incident reporting by professional users and operators: Form |
Notifications according to legal regulation § 88 para. 1 sentence 1 no. 7 (user, operator notifications) §§ 3, 4 and 6 MPAMIV | Reports of suspected serious incidents by professional users and operators | Via web application: Online form for notifications by users and patients pursuant to MPAMIV Or using the form linked below via e-mail to mp-vigilanz@bfarm.de Incident reporting by professional users and operators: Form |