MDCG guidance documents — by topic
MDCG guidance is published by the Medical Device Coordination Group and represents the authoritative interpretation of MDR/IVDR requirements by the European Commission and member states. It is not legally binding but is followed by notified bodies and competent authorities and departing from it requires justification.
This site provides general information only. Always refer to the original guidance documents on the European Commission DG SANTE website for authoritative text. Guidance is updated regularly — check for the most current version.
Classification & borderline
| Document | Title | Applies to |
|---|---|---|
| MDCG 2019-11 | Guidance on qualification and classification of software | MDR/IVDR |
| MDCG 2021-24 | Guidance on classification of software under Rule 11 MDR | MDR |
| MDCG 2022-5 | Borderline manual between MDR and other EU legislation | MDR/IVDR |
| MDCG 2020-16 | Guidance on companion diagnostics | IVDR |
Clinical evaluation & performance evaluation
| Document | Title | Applies to |
|---|---|---|
| MDCG 2019-6 | Guidance on sufficient clinical evidence for legacy devices | MDR |
| MDCG 2020-5 | Guidance on clinical evaluation — MDR Art. 61 and Annex XIV | MDR |
| MDCG 2020-6 rev.2 | Guidance on templates for CER and clinical evaluation | MDR |
| MDCG 2020-7 | Guidance on PMCF plan and PMCF evaluation report | MDR |
| MDCG 2021-6 | Guidance on sufficient clinical evidence for legacy devices | MDR |
| MDCG 2022-9 | Guidance on performance evaluation for IVDs | IVDR |
Technical documentation
| Document | Title | Applies to |
|---|---|---|
| MDCG 2019-9 | Summary of safety and clinical performance (SSCP) | MDR |
| MDCG 2020-6 | Technical documentation templates | MDR/IVDR |
| MDCG 2022-14 | Guidance on GSPR Annex I | MDR/IVDR |
Post-market surveillance & vigilance
| Document | Title | Applies to |
|---|---|---|
| MDCG 2020-7 | PMCF plan template and guidance | MDR |
| MDCG 2022-21 | Guidance on PSUR | MDR/IVDR |
| MDCG 2023-3 | Guidance on serious incident reporting | MDR/IVDR |
| MDCG 2019-14 | Vigilance reporting — worked examples | MDR |
Field safety corrective actions
| Document | Title | Applies to |
|---|---|---|
| MDCG 2022-14 | Guidance on FSCAs and FSNs | MDR/IVDR |
| MDCG 2023-3 | Guidance including FSCA notification | MDR/IVDR |
UDI & EUDAMED
| Document | Title | Applies to |
|---|---|---|
| MDCG 2018-5 | UDI guidance — general | MDR/IVDR |
| MDCG 2019-2 | Summary of EUDAMED modules | MDR/IVDR |
| MDCG 2021-22 | Registration of Class I devices | MDR |
Special device types
| Document | Title | Applies to |
|---|---|---|
| MDCG 2019-11 | Software qualification and classification | MDR/IVDR |
| MDCG 2019-16 | Cybersecurity for medical devices | MDR |
| MDCG 2020-10 | CMR substances and endocrine disruptors | MDR |
| MDCG 2021-3 | Custom-made devices | MDR |
| MDCG 2022-4 | Systems and procedure packs; reprocessing | MDR |
Notified bodies & conformity assessment
| Document | Title | Applies to |
|---|---|---|
| MDCG 2019-6 | NB assessment of clinical evaluation documentation | MDR |
| MDCG 2020-3 | Guidance on significant changes to MDR/IVDR devices | MDR/IVDR |
| MDCG 2020-11 | Conformity assessment procedure selection | MDR/IVDR |
Transitional provisions
| Document | Title | Applies to |
|---|---|---|
| MDCG 2021-25 | Guidance on application of MDR transitional provisions | MDR |
| MDCG 2022-14 | Additional guidance on transitional provisions | MDR/IVDR |
How to access MDCG guidance
All MDCG guidance is published and freely available on the European Commission DG SANTE website:
Guidance is organised by topic on the Commission website. New and revised documents are announced through the MDCG meeting schedule and the Commission's medical devices news page.