MDCG Guidance Documents
The Medical Device Coordination Group (MDCG) consists of representatives of EU Member States and provides guidance on MDR/IVDR implementation.
Clinical Evaluation
| Document | Title | Year |
|---|---|---|
| MDCG 2020-1 | Guidance on clinical evaluation of MD software | 2020 |
| MDCG 2020-5 | Clinical evaluation — Equivalence | 2020 |
| MDCG 2020-6 | Sufficient clinical evidence for legacy devices | 2020 |
| MDCG 2020-13 | Clinical Evaluation Report template | 2020 |
| MDCG 2022-2 | General principles of clinical evidence | 2022 |
Post-Market Surveillance
| Document | Title | Year |
|---|---|---|
| MDCG 2019-11 | Guidance on PMS system | 2019 |
| MDCG 2020-7 | PSUR guidance | 2020 |
| MDCG 2021-1 | Vigilance terms and definitions | 2021 |
| MDCG 2023-3 | Q&A on PMS and vigilance | 2023 |
Technical Documentation
| Document | Title | Year |
|---|---|---|
| MDCG 2019-9 | Summary of Safety and Clinical Performance (SSCP) | 2019 |
| MDCG 2020-16 | Classification of medical devices | 2020 |
| MDCG 2021-24 | Classification of medical devices (Rev.1) | 2021 |
UDI & EUDAMED
| Document | Title | Year |
|---|---|---|
| MDCG 2019-2 | UDI Q&A | 2019 |
| MDCG 2021-17 | UDI assignment for software | 2021 |