European guidance documents

The European Commission offers a series of guidance 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.

An overview of the most relevant guidance documents for clinical investigations with medical devices is provided below:

Clinical investigation and evaluation
MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
MDCG 2020-13 Clinical evaluation assessment report template

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
In-house devices
MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Custom-made devices
MDCG 2021-3 Questions and answers on custom-made devices
New technologies
Infographic Is your software a medical device?
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
Borderline and Classification
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.

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