Competent Authority
Contact Details
BfArM is responsible for clinical investigations of medical devices and for performance test of in vitro diagnostic agents, with the exception of those for which the Paul-Ehrlich-Institute is responsible.
Clinical Investigation Authorisation / Registration / Notification
An approval or notification process is not required, if within the clinical trial the MD is used within the intended use label and without additional invasive or stressful procedures beyond the normal conditions of use of the product (§ 47 (3) Medizinprodukterecht-Durchführungsgesetz (MPDG)).
Furthermore, notification to NCA instead of approval is possible for “sonstige klinische Prüfungen” (other clinical trials) according to §3 (4) MPDG.
Exemptions for “sonstige klinische Prüfungen” (other clinical trials) apply, if a clinical trial is
a) not part of a systematic and planned product development process or the Product observation of a current or future manufacturer,
b) is not carried out with the aim of ensuring the conformity of a product with the requirements of Regulation (EU) 2017/745,
c) serves to answer scientific or other questions,
d) outside of a clinical development plan according to Annex XIV Part A Number 1 Letter a of Regulation (EU) 2017/745.
Regarding "CE-marked MD used within label are exempted from any notification obligation to CA" ticked "NO":
These are not clinical trials or performance studies requiring approval according to the MDR or the IVDR if the medical device is used exclusively within the scope of its intended purpose (strictly according to the instructions for use, incl. indications, contraindications, etc.) and no additional invasive or stressful examinations are carried out. In general, however, professional guidelines for the physicians involved must be observed and an appropriate ethics committee must be involved. Furthermore, Art 74 of the EU-Regulation 745/2017 (PMCF) is valid.
Submission Format
It is mandatory to use the DMIDS portal for trial submission. The NCAs and the ECs will be informed automatically via DMIDS. Language of the DMIDS is German.
Language of Submission
MPDG Art. 38 https://www.gesetze-im-internet.de/mpdg/__38.html
Submission Fees
For clinical trials according to Art. 71, 75 and 80 MDR
- Clinical trials: 2.000 – 9.900 EURO
- Substantial Amendments: 600- 2.000 EURO
- Notification of SAE: 100 - 400 EURO
See “Besondere Gebührenverordnung BMG” (Special Fee Ordinance BMG) – BMGBGebV Annex section 8 and 9.
For “sonstige klinische Prüfungen” according to § 47 (3) MPDG (CE-marked device within intended use and no additional invasive/harmful procedures), no approval/notification of NCA is needed, therefore no fees apply.
See “Besondere Gebührenverordnung BMG” (Special Fee Ordinance BMG) – BMGBGebV Annex section 8 and 9.
Fees for Ethic Committees are subject to the fee regulations of the federal states and ECs, respectively.
See “Besondere Gebührenverordnung BMG” (Special Fee Ordinance BMG) – BMGBGebV Annex section 8 and 9.
Timelines Autorisation
Application for a decision on the authorisation requirement of a clinical trial of a medical device or a performance study of an in vitro diagnostic medical device:
If the regulatory classification of a planned clinical investigation or performance study cannot be clarified, the parties involved in the conduct, authorisation or monitoring of the clinical investigation / performance study (see below) may submit an application for a decision on the authorisation requirement to the higher federal authority in accordance with Section 6(3) MPDG.
For a decision on the authorisation requirement by the BfArM, an informal application for a decision on the authorisation requirement can be submitted to the BfArM in accordance with Section 6 (3) MPDG. (Application for a decision on the authorisation requirement of a clinical trial of a medical device or a performance study of an in vitro diagnostic medical device)
Decision tree on the application and notification procedures according to MDR / MPDG: BfArM's decision tree
Amendments/Substantial Amendments
Submission of substantial amendments to NCA and EC via DIMDS platform.
Safety Reporting
MDCG-SAE reporting table (see appendix of the MDCG guideline)
End of trial
Additional Information & Specifics
The competent regional authority ("Landesbehörde") is automatically informed via the electronic notification process; no specific application required.
Ethics Committee
Contact Details
EC approval has to be applied by the responsible EC via DMIDS BEFORE CTA (sequential process).
Responsible EC is the public law EC appointed to the investigator, Principal Investigator or Lead investigator, if appropriate (according to § 33 MPDG).
An approval or notification process involving NCAs is not required, if within the clinical trial the MD is used within the intended use label and without additional invasive or stressful procedures beyond the normal conditions of use of the product (§ 47 (3) Medizinprodukterecht-Durchführungsgesetz (MPDG)). However, for this clinical studies as well as for other clinical studies not covered by MDR. CTR or IVDR an advice is required by the responsible EC according to (Model) Professional Code for Physicians in Germany (MBO) Art. 15.
Ethical Review - General
Single-Centre Studies - Ethical Review
There are 52 local ECs responsible for studies with human medicines.
The local EC depends on the location of the trial site.
Multi-Centre Studies - Ethical Review
There are 52 local ECs responsible for studies with human medicines.
The responsible EC for clinical trials according to Art. 62, 74 and 82 MDR depends on the location of the investigator, Principal Investigator or Lead Investigator, if applicable (§ 33 MPDG).
Submission of Application
Submission Format
The portal of German Medical Devices Information and Database System - DMIDS
Language of Submission
Submission Fees
Timelines Ethical Review
§§ 32 – 37 MPDG for clinical trials (approval process)
§§ 48 – 52 MPDG for other clinical trials according to MPDG (notification process)
Amendments/Substantial Amendments
Notification of substantial amendments to the federal CA and all involved ECs is performed by use of the DMIDS.
§§ 54 – 59 MPDG
Safety Reporting
Art. 80 MDR
§ 64 MPDG for “sonstige klinische Prüfungen“
End of trial
Study Specific Requirement
Sponsor
Study participants - informed consent
Study participants - vulnerable population
According to MDR
According to MDR
According to MDR
According to MDR
According to MDR
Study participants - compensation & reimbursement
Compensation fees for subjects (patients or healthy volunteers) participating in clinical investigations of MD (interventional, observational, combination studies, registries):"Aufwandsentschädigung" or travel costs.
Data protection
National Legislations
General Information
Federal Institute for Drugs and Medical Devices/ Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM):
Section: Medizinprodukte > Regulatorischer Rahmen > Gesetze und Verordnungen
Juris BMJ: Free database of the Federal Ministry of Justice covering most of the German federal law
Investigations on Medical Devices
Radiation & Radiotherapy