For post-market follow-up clinical investigations (PMCF CI) as per Art. 74(1) MDR 2017/745, submissions to the Ethics Committee (EC) and the notification to the Competent Authority (CA) need to be done via DMIDS (Deutsches Institut für Medizinische Dokumentation und Information, German Medical Devices Information and Database System) as a sequential submission procedure.
This resembles the previous CI submissions as per §23b MPG (Medizinproduktegesetz, Medical Device Act) in connection with §7(3) MPKPV (Verordnung über klinische Prüfungen von Medizinprodukten, Ordinance on clinical investigations with medical devices) as an abbreviated submission. However, there are important differences under MDR 2017/745.
Understanding MDR Article 74(1) PMCF Clinical Investigations
Per the MDR 2017/745 and Medizinprodukterecht-Durchführungsgesetz (Medical Device Law Implementation Act, MPDG), all documents as listed in Annex XV Chapter II are to be included in the submission package, for the full review of the EC, and the notification to the CA.
Key Difference from Previous Procedure: A written positive opinion from an EC is required, but NO approval by the CA for the notification. The CI may commence after the positive opinion of the EC was obtained, and the earliest after 30 days of the notification to the CA.
The Clinical Investigation Identification number (CIV-ID) will be provided by the DMIDS as it was before. This blog summarizes the current submission requirements for an Art. 74(1) MDR PMCF Clinical Investigation in Germany, until EUDAMED is functional.
For Which Clinical Investigations Does This Route Apply?
The principle of ISO 14155:2020 Annex I post-market stage applies to clinical investigations as per MDR 2017/745 Article 74.1 PMCF clinical investigations and the Art. 82 other clinical investigations.
Post-Market Stage Characteristics
Article 74.1 PMCF clinical investigations fall under the post-market stage, and the confirmatory design and interventional aspects need to be taken into account for planning these studies.
Submission Type Matrix
| CI per MDR Art. | Class of Device | Regulatory Status | Submission Type |
|---|---|---|---|
| 74(1) | I through III | CE-marked, additional burdensome or invasive, for indications in Art. 62.1 | Notification ≥30 days prior to commencement of study, positive opinion from an EC included |
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. The EC's favorable opinion will be included after EC review, when the notification to the CA will be performed.
Prepare Complete Submission Package
Compile all required documents from Annex XV Chapter II MDR 2017/745, including those for EC-only review, CA-only review, and joint review.
Submit to Ethics Committee via DMIDS
Submit the complete package to the EC for scientific and ethical review. The EC will perform a full review of the submission package.
Obtain EC Favorable Opinion
Receive written positive opinion from the EC. This is a mandatory requirement before proceeding to CA notification.
Notify Competent Authority
Submit notification to the CA via DMIDS, including the EC's favorable opinion. No CA approval is required.
Obtain CIV-ID & Commence Study
Receive Clinical Investigation Identification number (CIV-ID) from DMIDS. Study may commence earliest after 30 days of CA notification.
Required Submission Documents (Annex XV Chapter II)
Documents required to support a submission with respect to Annex XV, Chapter II MDR 2017/745 are comprehensive and must be organized for both EC and CA review:
Core Documentation Requirements
- Clinical Investigation Plan (CIP) with detailed protocol and amendments
- Curriculum Vitae of the coordinating investigator
- Investigator's Brochure (IB) or equivalent device documentation
- Quality Overall Summary (QOS) or technical documentation
- Risk Management Report (RMR)
- Clinical Evaluation Report (CER) or Clinical Evaluation Plan (CEP)
- Insurance or indemnity information
- Ethics Committee approval or opinion
- Informed Consent Form (ICF) and translations
- Device identification and technical specifications
Additional Documentation by Review Type
EC-Only Review Documents
Scientific merit assessment, ethical considerations, subject protection measures, and informed consent adequacy.
CA-Only Review Documents
Device regulatory status verification, market authorization documentation, and compliance with national requirements.
Joint EC/CA Review Documents
Clinical investigation plan, risk management, device safety data, and post-market surveillance plans.
Submission Timelines & Review Procedures
Ethics Committee Review Timeline
EC Review Clock
Day 0: Submission received by EC via DMIDS
Day 7: EC acknowledges receipt and begins review
Day 30: EC favorable opinion expected (may be extended if additional information requested)
Clock Stop: The reviewer clock-stops when additional documents are requested
Competent Authority Notification Timeline
CA Review Clock
Day 0: Notification received by CA via DMIDS (after EC favorable opinion)
Day 30: Earliest date for study commencement (no CA approval required)
CIV-ID Issued: DMIDS provides Clinical Investigation Identification number
Clock Stop: The reviewer clock-stops when additional documents are requested
Key Differences from Previous MPG/MPKPV Procedure
EC Review Scope
Previous: Full review. MDR: Full review (unchanged)
CA Review Scope
Previous: Limited submission package. MDR: Limited submission package (unchanged)
CA Approval
Previous: CA approval required. MDR: NO CA approval required (KEY CHANGE)
Study Commencement
Previous: After CA approval. MDR: After EC opinion + 30 days CA notification
Sequential Process
Previous: Parallel submission possible. MDR: Sequential submission required
Document Organization
Previous: Separate packages. MDR: Single package with clear labeling
DMIDS Submission Process
The DMIDS (Deutsches Institut für Medizinische Dokumentation und Information) system is the official portal for all clinical investigation submissions in Germany under MDR 2017/745.
DMIDS Submission Steps
- Register as a sponsor or authorized representative in DMIDS
- Create a new clinical investigation record with device and study information
- Upload all required documents in specified formats (PDF, Word, Excel)
- Clearly label documents for EC review, CA review, or both
- Submit to EC first via DMIDS portal
- Upon EC favorable opinion, submit notification to CA via DMIDS
- Receive CIV-ID confirmation from DMIDS
- Maintain all correspondence and documents in DMIDS for audit trail
DMIDS Access & Support
For technical support and access to DMIDS, contact the German Competent Authority (BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte) or visit the official DMIDS portal. Ensure all submissions comply with DMIDS technical requirements and file format specifications.
Submission Best Practices for Germany
- Verify all required documents from Annex XV Chapter II are included and complete
- Ensure Clinical Investigation Plan complies with ICH-GCP and ISO 14155:2020
- Provide clear device identification with UDI and technical specifications
- Include comprehensive risk management demonstrating device safety
- Organize documents with clear labeling for EC-only, CA-only, and joint review
- Ensure Informed Consent Form is ethically sound and legally compliant
- Verify EC and CA contact information is accurate in DMIDS
- Plan for 30-day minimum timeline from EC opinion to study commencement
- Maintain organized documentation for audit trail and regulatory inspection
- Monitor DMIDS for any requests for additional information or clarifications
- Prepare for potential substantial modifications during study conduct
- Establish clear communication protocols with EC and CA throughout study
Additional Regulatory Considerations
Device Classification & Regulatory Status
Ensure your device is properly classified under MDR 2017/745 and holds valid CE marking. PMCF clinical investigations are typically conducted for CE-marked devices requiring additional evidence for specific indications or to address post-market safety concerns.
Burdensome or Invasive Procedures
Art. 74(1) applies specifically to CE-marked devices that are "additional burdensome or invasive" for indications covered by Art. 62.1. Ensure your study design reflects the post-market stage and confirmatory nature required by ISO 14155:2020 Annex I.
Post-Market Surveillance Integration
PMCF clinical investigations should be integrated with your broader post-market surveillance plan. Results from PMCF studies contribute to the Clinical Evaluation Report (CER) and support ongoing compliance with GSPR (General Safety and Performance Requirements).
EUDAMED Transition & Future Implementation
The current DMIDS submission process for Art. 74(1) PMCF clinical investigations will eventually transition to the EUDAMED system. EUDAMED is the European Union electronic system for medical devices information and will eventually replace national systems like DMIDS.
Important: Stay informed about EUDAMED implementation timelines. When EUDAMED becomes fully operational, submission procedures and document requirements may be updated. Current DMIDS submissions will serve as the interim solution and will likely be migrated to EUDAMED.
Key Takeaways
- MDR Art. 74(1) PMCF clinical investigations in Germany require sequential submission via DMIDS
- EC favorable opinion is mandatory; CA approval is NOT required (key difference from previous procedure)
- Study may commence earliest 30 days after CA notification, following EC favorable opinion
- All Annex XV Chapter II documents must be included in a single submission package
- Documents must be clearly labeled for EC-only, CA-only, or joint review
- Clinical Investigation Identification number (CIV-ID) is provided by DMIDS
- EC review typically takes 30 days; CA notification requires 30-day waiting period