Introduction
While under the MDD 93/42/EEC and AIMDD 90/385/EEC and Medizinproduktegesetz (Medical Device Act, MPG) the submissions for pre-CE mark clinical investigations with medical devices via Deutsche Institut für Medizinische Dokumentation und Information (German Institute for Medical Documentation and Information, DIMDI) were supposed to be done in parallel to the Competent Authority (CA) and the Ethics Committees (EC), this now changed to be a sequential submission procedure under MDR 2017/745 and Medizinprodukterecht-Durchführungsgesetz (Medical Device Law Implementation Act, MPDG).
In 2020, the DIMDI was integrated into Bundesamt für Arzneimittel und Medizinprodukte (Federal Office for Pharmaceuticals and Medical Devices, BfArM), now called the German Medical Devices Information and Database System (DMIDS), but the submission mask remains familiar to what it was previously, and the CIV-ID will be provided by the DMIDS as it was before.
Key Point
This guide summarizes the current submission requirements for a pre-market Clinical Investigation in Germany, until the European database on medical devices (EUDAMED) becomes functional.
For Which Clinical Investigations Would This Route Apply?
This route would apply for clinical investigations as per Art. 62 and Art. 74 (2) MDR 2017/745:
| CI per MDR Art. | MPDG Reference | Class of Device | Regulatory Status of Device | Submission Type |
|---|---|---|---|---|
| 62, 70 (7)a | MPDG §31 (1) | Class I and non-invasive IIa | Non-CE marked, novel device, for indications in Art. 62.1 | Abbreviated Application |
| 62, 70 (7)b | MPDG §31 (2) | All other than Class I and non-invasive IIa | Non-CE marked, novel device, for indications in Art. 62.1 | Full Application |
| 74.2, 70 (7)a | MPDG §31 (1) | Class I and non-invasive IIa | CE-marked, new intended use, for indications in Art. 62.1 | Abbreviated Application |
| 74.2, 70 (7)b | MPDG §31 (2) | All other than Class I and non-invasive IIa | CE-marked, new intended use, for indications in Art. 62.1 | Full Application |
Note on German Regulation
In the German Regulation, non-invasive Class IIb devices are not included in the abbreviated application pathway.
Sequential Submission Flow
Since it is now a sequential submission process, the submission package for the initial submission needs to include all required documents, whether documents are only for CA review, or only EC review, or for both.
EC Favorable Opinion
The EC's favorable opinion will be included after EC review, when the submission to the CA will be performed.
Submission Documents
The following documents are to be included into the submission package to support a submission related to MDR 2017/745 Art 62 and 74 (2) clinical investigations.
Complete Documentation Package
All required documents must be submitted together, whether they are intended for CA review only, EC review only, or for both authorities. This ensures a comprehensive and efficient review process.
Submission Timelines
Review timelines vary based on device classification and submission type. Understanding these timelines is critical for project planning and regulatory strategy.
Class I and Non-Invasive Class IIa Medical Devices
Ethics Committee (EC) Review Timeline
Initial Review Period: 30 days
The EC conducts its initial review of the submission package.
Clock-Stop Trigger: The reviewer clock stops when additional documents are requested by the EC.
Competent Authority (CA) Review Timeline
Initial Review Period: 30 days
The CA conducts its initial review following EC favorable opinion.
Clock-Stop Trigger: The reviewer clock stops when additional documents are requested by the CA.
All Other Medical Devices
(Excluding Class I and non-invasive Class IIa)
Ethics Committee (EC) Review Timeline
Initial Review Period: 60 days
The EC conducts a comprehensive review of the submission package for higher-risk devices.
Clock-Stop Trigger: The reviewer clock stops when additional documents are requested by the EC.
Competent Authority (CA) Review Timeline
Initial Review Period: 60 days
The CA conducts a thorough review following EC favorable opinion for higher-risk devices.
Clock-Stop Trigger: The reviewer clock stops when additional documents are requested by the CA.
Important Note on Clock-Stops
Both EC and CA review timelines include clock-stop provisions. When either authority requests additional information or clarification, the review clock pauses until the applicant provides the requested documents. This can significantly extend the overall review timeline.
Key Takeaways
Essential Points to Remember
- Pre-CE mark clinical investigations in Germany now follow a sequential submission procedure under MDR 2017/745 and MPDG
- DIMDI submissions are now managed through BfArM's German Medical Devices Information and Database System (DMIDS)
- Submission type (Abbreviated vs. Full Application) depends on device classification and regulatory status
- Class I and non-invasive Class IIa devices follow an abbreviated pathway with 30-day review timelines
- Higher-risk devices require full applications with 60-day review timelines
- EC favorable opinion must be obtained before CA submission
- Clock-stops occur when either authority requests additional documentation
- Complete submission packages must include all documents regardless of intended reviewer
- CIV-ID is provided by DMIDS following successful submission
- Current procedures remain in place until EUDAMED becomes fully operational
Expert Support for German Clinical Investigation Submissions
Navigating pre-CE mark clinical investigation submissions in Germany requires deep understanding of MDR 2017/745, MPDG regulations, and the sequential submission procedures managed by BfArM's DMIDS. The transition from parallel to sequential submissions, combined with varying timelines based on device classification, demands careful planning and regulatory expertise.
Eclevar MedTech specializes in supporting medical device and IVD manufacturers through complex regulatory submissions across the EU, UK, and USA. Our team brings over 20 years of combined experience in clinical affairs, regulatory strategy, and medical writing to help you navigate these requirements efficiently.
Whether you're preparing an abbreviated application for lower-risk devices or a comprehensive full application for higher-risk devices, our regulatory experts can guide you through every step of the German submission process.