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. In principle, the following are entitled to apply:

• Sponsors of a clinical investigation or performance study
• Ethics committees (treated as competent authorities in this procedure)
• Authorities of the "Länder"

Fees are charged for official acts in accordance with the special fee ordinance of the BMG (Annex Section 9 No. 1 BMGBGebV).

Decisions can only be made on a case-by-case basis for individual clinical investigations or performance studies. A general decision on specific facts or constellations is not possible.

Please note that the question of whether the investigational device is a medical device according to Article 2 No. 1 MDR or an in vitro diagnostic device according to Article 2 No. 2 IVDR must already have been answered. If this question is still open, an application for differentiation and / or classification according to Article 6 No. 2 MPDG can be submitted to the BfArM for clarification.

We request that you enclose at least the following documents on the specific clinical investigation or performance study with the informal, signed application in order to enable a proper and timely decision. In the following, you will find documents / key points that should be addressed depending on the constellation of the planned study:

Clinical investigation of a medical device

• Clinical investigation plan or synopsis of the clinical investigation
  - Purpose of the clinical investigation
  (Purpose according to Article 62(1) MDR / other clinical investigation according to § 3 No. 4 MPDG)
  - Will the subjects be exposed to additional invasive or burdensome procedures compared to the standard use of the investigational device?
• Sponsorship
  - Who is the sponsor?
  - To what extent is the manufacturer of the investigational device involved in the study?
• Information on the status of the investigational device(s)
  - Intended purpose
  - Risk class of the investigational device(s)
  - (Derivation based on the classification rules according to Annex VIII MDR for medical devices)
  - CE mark
  - Instructions for use
  - Planned use within the clinical investigation
  - Development status

Clinical performance study of an in vitro diagnostic device

• Performance study plan or synopsis of the performance study

  - Purpose of the clinical performance study
  - Who is sponsoring the study?

• Information on the status of the investigational device(s)
  - Intended use
  - CE marking (use according to intended purpose)
  - Instructions for use
  - intended use within the clinical performance study
  - Development status
  - Companion diagnostic?
• Information on the context of use of the IVD
  - Will subjects be exposed to additional invasive or burdensome procedures compared to the standard use of the investigational device?
  - Will subjects be exposed to other risks?
  - Sample collection: left-over samples only, for the purpose of the performance study, surgically invasive measures, risk of sample collection.
  - Influence of the result of the IVD on patient management (diagnostic/therapeutic decision)
  - Possibility of confirmation of the result by an established procedure

In addition, we request that the applicant provides an assessment with justification on the question of the regulatory classification of the clinical investigation / performance study and attaches it to the application.

Please submit the application electronically via the following email address: mpkp@bfarm.de . Use the subject: Application for a decision on the authorisation requirementt pursuant to Section 6 (3) of the MPDG.

The decision on the authorisation requirement is based on the legal requirements for clinical investigations of medical devices from the MDR (Article 2 and 62 - 82), IVDR (Article 2 and 57 - 76), for performance studies from the IVDR (Article 2 and 58 - 77) and the MPDG (Section 3 and Chapter 4). For decision-making purposes, other sources may be consulted, such as the MDCG guidance documents of the European Commission, which can be found at:

In the case of applications by Authorities of the "Länder" and ethics committees, the sponsor is always given the opportunity to comment. You can find directories of the Authorities of the "Länder" in Germany and of the competent ethics committees on our website on the German Medical Devices Information and Database System (DMIDS):