How long does the application process for a clinical investigation under MDR Art. 62 take?

For those in charge, it is worth separating two independent processes: voluntary preliminary consultation and the formal approval procedure.

1. Optional scientific consultation
Available through the BfArM or PEI, with no statutory processing deadline; in practice, consultation meetings usually take place three to six months after the application is submitted (Source: BfArM, consultation procedure). For medical devices, this consultation is offered prior to applying for approval of a clinical investigation.

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2. Formal approval procedure (Germany)

Requests for additional information pause the clock (clock-stop) – therefore, the deadlines do not add up to a guaranteed total processing time. The investigation may only begin after a positive ethics committee opinion and regulatory approval.

3. Multiple member states simultaneously For investigations in several EU member states, a single application can be submitted in accordance with Art. 78 MDR (Section 38 (2) MPDG). National non-harmonized requirements continue to vary from country to country; the European Commission maintains an overview of country-specific national requirements with links to the competent authorities (as of April 2026).

4. Depth of review depends on risk The scope and intensity of the substantive review by the ethics committee and the federal higher authority depend on the risk associated with the medical device and the clinical investigation itself. Higher-risk or invasive investigations typically lead to more queries and the involvement of experts – the preparation effort for a complete, query-free dossier is correspondingly higher.

(Reference: For investigations under Art. 74 MDR as well as cases involving no invasive or burdensome measures, where professional consultation by the coordinating investigator is provided instead, please see our separate FAQ.)

How MEDIACC supports you A complete dossier tailored to the respective risk class reduces requests for additional information and thus clock-stops in both procedural phases. MEDIACC supports you from study design and application documentation to coordination with ethics committees and federal higher authorities – including coordinated management across multiple national requirements for multi-country studies.

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(Last revised: July 2026)

Are you interested in learning if and how MEDIACC, as a CRO, can support you with clinical investigations in the medical device approval process? Contact us for an initial consultation!

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