The European Commission offers a series of documents to assist stakeholders in implementing the MDR.
The guidance documents have been endorsed by the Medical Device Coordination Group (MDCG) and aim at a uniform application of the MDR within the EU. These documents can be found at: Guidance - MDCG endorsed documents and other guidance.
The website of the European Commission provides information on the national requirements for IVD performance studies and the pilot coordinated assessment.
An overview of the most relevant guidance documents for clinical investigations with medical devices is provided below:
| MDCG 2024-15 | Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED |
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| MDCG 2024-10 | Clinical evaluation of orphan medical devices |
| MDCG 2024-5 | Guidance on the Investigator’s Brochure content |
| MDCG 2024-3 | Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices |
| MDCG 2021-6 | Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation |
| MDCG 2020-13 | Clinical evaluation assessment report template |
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MDCG 2020-10/2 MDCG 2020-10/1 |
Guidance on safety reporting in clinical investigations Appendix: clinical investigation summary safety report form |
| MDCG 2020-8 | Guidance on PMCF evaluation report template |
| MDCG 2020-7 | Guidance on PMCF plan template |
| MDCG 2020-6 | Guidance on sufficient clinical evidence for legacy devices |
| MDCG 2020-5 | Guidance on clinical evaluation – Equivalence |
| MDCG 2019-9 | Summary of safety and clinical performance |
| MDCG 2023-1 | Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
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| MDCG 2021-3 | Questions and answers on custom-made devices |
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| Infographic | Is your software a medical device? |
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| MDCG 2020-1 | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software |
| MDCG 2019-16 revision 1 | Guidance on cybersecurity for medical devices |
| MDCG 2019-11 | Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
| Manual on Borderline |
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v1 Background note on the use of the Manual on borderline and classification for medical devices under the Directives. |
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| MDCG 2022-5 | Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices |
| MDCG 2021-24 | Guidance on classification of medical devices |
| Helsinki Procedure | Helsinki Procedure for borderline and classification under MDR & IVDR |