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. 1 and 2 | Applications for the classification and qualification of medical devices | 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 |