EU MDR · Germany · MPDG
Pre-CE clinical investigations in Germany, the sequential way.
Germany moved from a parallel to a sequential submission under the MDR and MPDG. Know which Article 62 / 74(2) pathway applies, what BfArM and the Ethics Committee each need, and how to avoid a returned file.
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German submissions, run by German-market specialists.
A sequential submission is unforgiving of a missing document. Ours are prepared by regulatory and clinical operations specialists who know exactly what BfArM and the Ethics Committees expect.
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Clinical investigation plans and Competent Authority submissions under EU MDR and national law.
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Multi-country study start-up, including German BfArM and Ethics Committee submissions.
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The German pre-CE route, step by step.
The route
From the legal basis to a validated German submission.
This guide summarises the current requirements for a pre-market clinical investigation in Germany, until the European EUDAMED database becomes functional.
01 / 06
From parallel to sequential
Under the MDD 93/42/EEC, AIMDD 90/385/EEC and the German Medical Device Act (MPG), pre-CE submissions via DIMDI were made in parallel to the Competent Authority (CA) and the Ethics Committees (EC). Under EU MDR 2017/745 and the MPDG, this changed to a sequential procedure — a fundamental shift in how the package is assembled and timed.
02 / 06
BfArM, DMIDS and the CIV-ID
In 2020, DIMDI was integrated into BfArM, and the system is now the German Medical Devices Information and Database System (DMIDS). The submission mask remains familiar, and the CIV-ID is still provided by the DMIDS as it was before.
03 / 06
Which pathway applies (Article 62 / 74.2)
The route applies to clinical investigations under Article 62 and Article 74(2) of the MDR, referenced to MPDG §31.
| MDR Art. | MPDG | Device class | Regulatory status | Application |
|---|---|---|---|---|
| 62, 70(7)a | §31(1) | Class I & non-invasive IIa | Non-CE, novel device (Art. 62.1 indications) | Abbreviated |
| 62, 70(7)b | §31(2) | All others | Non-CE, novel device (Art. 62.1 indications) | Full |
| 74.2, 70(7)a | §31(1) | Class I & non-invasive IIa | CE-marked, new intended use | Abbreviated |
| 74.2, 70(7)b | §31(2) | All others | CE-marked, new intended use | Full |
04 / 06
Abbreviated vs full application
The class decides the burden: Class I and non-invasive Class IIa devices use the abbreviated application; everything else uses the full application. An important German specificity: non-invasive Class IIb devices are not included in the abbreviated pathway, unlike some assumptions carried over from other jurisdictions.
05 / 06
The sequential submission flow
Because the process is now sequential, the initial submission package must include all required documents — whether for CA review only, EC review only, or both. The EC’s favourable opinion is then added after EC review, when the file is submitted to the Competent Authority.
Practical consequence
- Assemble one complete package up front, not two parallel ones
- Sequence the EC and CA steps so the favourable opinion arrives in time
- Confirm the DMIDS mask fields and the CIV-ID before submitting
06 / 06
How to avoid a returned file
Most German rejections come from an incomplete initial package or a mis-classified pathway. We map your device to the exact Article 62 / 74(2) row, assemble the full sequential package, and manage the EC-then-CA timing so first patient in is not delayed. For the underlying application forms, see our MDCG 2021-8 guide.
Germany at a glance
The route, structured.
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