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Pre-CE mark Clinical Investigation with Medical Devices: submissions in Germany

Eclevar Equivalence in Great Britain – How to use it!

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. 

This blog summarizes the current submission requirements for a pre-market Clinical Investigation in Germany, until European database on medical devices (EUDAMED) is 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, see table below:  

CI per MDR Art. 

Class of Device 

Regulatory Status of Device 

Submission type 

62, 70 (7)a 

MPDG §31 (1) 

I and non-invasive IIa  

(NOTE: in the German Regulation, non-invasive Class IIb devices are not included)  

Non-CE marked, novel device, for indications in Art. 62.1 

Abbreviated Application CI may start immediately after Validation Date if no negative opinion from an EC 

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) 

I and non-invasive IIa 

(NOTE: in the German Regulation, non-invasive Class IIb devices are not included) 

CE-marked, new intended use, for indications in Art. 62.1 

Abbreviated Application CI may start immediately after Validation Date if no negative opinion from an EC 

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 

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 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.  

  • Cover letter 
  • Billing address  
  • Clinical Investigation Plan (CIP) 
  • Investigator’s Brochure 
  • Synopsis of the CIP in German  
  • Description of procedure/investigational methods 
  • Preclinical evaluation 
  • Instructions for use in German 
  • Risk Assessment 
  • Assurance General Safety and Performance Requirements  
  • Plan for further treatment of subjects 
  • Power of attorney for representatives 
  • Results of biological safety assessment 
  • Proof of technical safety 
  • Functionality of Medical Device (MD)/information on MD  
  • Risk analysis and assessment including residual risks 
  • List of essential safety and performance requirements  
  • Safety reporting Declaration 
  • Information Investigational Site Feasibility  
  • Qualification of other personnel 
  • Qualification investigator 
  • Subject/patient information, declaration of consent  
  • Justification inclusion of particularly vulnerable persons  
  • Evidence of insurance 
  • Declaration of inclusion of dependent persons 
  • Declaration of data protection 
  • Financing of the Clinical Investigation/essential contractual contents  
  • Criteria or conditions and procedures for suspension or termination  
  • Summary risk assessment 
  • Evidence/data for sterile applied MP or sterilization validations  
  • CV of Investigator 
  • Proof of experience in the field of application of MD 
  • Proof of familiarity with basic principles of MD law 
  • Proof of familiarity with legal/scientific basics of the Clinical Investigation 
  • Demonstrated familiarity with CIP / IB 
  • Evidence of CE marking, if applicable 
  • Clinical evaluation plan 
  • Information on the drug, tissue, or derivative 
  • Technical documentation 
  • Optional attachments 
  • The PDF form of the application, including the list of attachments, is automatically generated by the system 

 

Submission Timelines 

Class I and non-invasive Class IIa Medical Devices: 

EC:  

  • 10 days for validation of the submission 
  • Date of confirming completeness is the validation date 
  • If the submission package is incomplete, the Sponsor has 10 days to complete the application 
  • Lead EC: 30 days for review after Validation Date, additional 15 days if an expert is to be involved  
  • Local EC: 20 days for review after Validation Date 
  • The EC may request additional information once during this time. 
  • Sponsor needs to provide the requested information within 45 days 
  • The EC will provide an opinion, either positive or negative for the CI 
 

The reviewer clock-stops when additional documents are requested 

CA:  

  • 10 days for validation of the submission, additional 5 days if requested by Member State.  
  • If the submission package is incomplete, the Sponsor has 10 days to complete the application, on application this can be extended to 20 days 
  • Date of confirming completeness is the validation date.  
  • CI may start immediately after the validation if there is no negative opinion from an EC. 

The reviewer clock-stops when additional documents are requested. 

All other Medical Devices: 

(Exempt the above mentioned Class I and non-invasive Class IIa) 

EC:  

  • 10 days for validation of the submission 
  • Date of confirming completeness is the validation date 
  • If the submission package is incomplete, the Sponsor has 10 days to complete the application 
  • Lead EC: 30 days for review after Validation Date, additional 15 days if an expert is to be involved  
  • Local EC: 20 days for review after Validation Date 
  • The EC may request additional information once during this time. 
  • Sponsor needs to provide the requested information within 45 days. 
  • The EC will provide an opinion, either positive or negative for the CI 

The reviewer clock-stops when additional documents are requested. 

CA:  

  • 10 days for validation of the submission, additional 5 days for validation, if requested by Member State 
  • If the submission package is incomplete, the Sponsor has 10 days to comment or to complete the application, on application this can be extended to 20 days 
  • The date of confirming completeness is the validation date 
  • 45 days for review after Validation Date, additional 20 days if an expert is to be involved  
  • The CA may request additional information once during this time. 
  • Sponsor needs to provide the requested information within the timeline given by the CA. 
  • The CA will provide authorization of the CI, if there is no negative opinion from an EC. 

The reviewer clock-stops when additional documents are requested. 

Thank you for your time, and interest. ECLEVAR MedTech posts regularly on topics related to Medical Devices and IVDs – Regulatory, Clinical, Medical Writing, in Australia, the EU, the UK, and the USA.  

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