EU MDR · Clinical investigation · MDCG 2021-8
Submitting a clinical investigation while EUDAMED waits.
With the EUDAMED clinical investigations module still delayed, MDCG 2021-8 is how sponsors apply to Competent Authorities. Here is what the six annexes contain and how to submit without a rejection.
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Clinical investigation plans, GSPR checklists and Competent Authority submissions under EU MDR.
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Charline Petitdemange
Study start-up and multi-country Competent Authority submissions across Europe.
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MDCG 2021-8, annex by annex.
The guidance
From a delayed system to a clean submission.
Under EU MDR 2017/745, sponsors must submit a clinical investigation application or notification to each participating Member State via EUDAMED (the electronic system referred to in Article 73). EUDAMED remains delayed, so MDCG 2021-8 provides the forms that bridge the gap.
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Why MDCG 2021-8 exists
The MDCG created this guidance to support sponsors and Competent Authorities in the submission process in the absence of a functional EUDAMED. It gives everyone a common set of documents and forms to use until the electronic system is live.
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What the guidance provides
MDCG 2021-8 sets out the documentation and forms required for clinical investigation applications and notifications under the MDR. The heart of it is six downloadable annexes; they are helpful to Competent Authorities and sponsors alike, though you should always confirm whether the relevant national authority requires its own official forms.
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The six annexes
Together, the annexes form the backbone of any submission.
Application / notification form
The primary form, with all data fields based on the EUDAMED module under development.
Additional investigational devices
Duplicate of Section 3 for studies using more than one investigational device.
Additional comparator devices
Duplicate of Section 4 for multiple comparators: therapy, placebo, no treatment or a device.
Additional investigation sites
Duplicate of Section 5, completed for each additional national site and country.
Supporting-documents checklist
Mandatory and conditional documents required to support the submission.
GSPR & standards checklist
General Safety and Performance Requirements, standards and scientific-advice checklist.
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Inside the application form (Annex 1)
The application/notification form is the cornerstone, and it previews what the EUDAMED clinical investigations module will require.
Key fields
- Sponsor and legal-representative identification
- Investigation type (pilot, pivotal, post-market) and submission type (initial, substantial modification, withdrawal)
- Participating countries in EU/EEA/UK (Northern Ireland), Turkey and Switzerland, and outside the EU/EEA
- Clinical investigation title and the clinical investigation plan (CIP)
- Scientific rationale, design, objectives, population and duration
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The checklists that stop rejections
Annex 5 and Annex 6 are where most submissions live or die. A complete supporting-documents checklist and an accurate GSPR and standards checklist are what let a Competent Authority validate quickly instead of returning the file. We build both to the exact expectation of the target authority.
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Submitting across countries
Multi-country studies multiply the paperwork: additional site annexes per country, and national forms where the NCA requires them. Our clinical operations team manages the full submission across participating states, so first patient in is never delayed by a formatting mismatch. See how we handle national specifics for pre-CE submissions in Germany.
MDCG 2021-8 at a glance
The submission, structured.
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