Guidance documents — by device class & type
About this page
This page organises key MDCG and other official guidance by device class and type, making it easier to find the guidance most relevant to a specific product.
Software & SaMD
| Document | Source | Summary |
|---|---|---|
| MDCG 2019-11 | MDCG | Qualification and classification of software — the foundational guidance |
| MDCG 2021-24 | MDCG | MDR Rule 11 classification — detailed decision trees |
| MDCG 2019-16 | MDCG | Cybersecurity for connected and standalone software devices |
| EU AI Act implementation guidance | Commission | Overlap between MDR software and high-risk AI obligations |
Active devices (including electro-medical equipment)
MDCG 2020-10 is listed twice in the guidance index with conflicting subjects. Verify the correct subject for MDCG 2020-10 from the Commission website and ensure consistency across all pages.
Implantable devices
| Document | Source | Summary |
|---|---|---|
| MDCG 2021-6 | MDCG | Clinical evidence for legacy implantable devices |
| MDCG 2022-21 | MDCG | PSUR for implantables |
| EN ISO 10993-6 | ISO (harmonised) | Local effects after implantation |
| EN ISO 14242 series | ISO (harmonised) | Wear simulation for orthopaedic joints |
Drug-device combinations
| Document | Source | Summary |
|---|---|---|
| MDCG 2022-5 | MDCG | Borderline with medicinal products — integral combinations |
| EMA guideline on quality of medical devices combined with medicinal products | EMA | Drug component requirements in device-led combinations |
IVDs (IVDR-specific)
| Document | Source | Summary |
|---|---|---|
| MDCG 2022-9 | MDCG | Performance evaluation for IVDs |
| MDCG 2020-16 | MDCG | Companion diagnostics — classification and conformity assessment |
| MDCG 2022-10 | MDCG | IVDR classification guidance — worked examples |
| EU reference laboratory guidance | Commission | Class D IVD batch testing |
Custom-made devices
| Document | Source | Summary |
|---|---|---|
| MDCG 2021-3 | MDCG | Custom-made device obligations under MDR |
Systems and procedure packs
| Document | Source | Summary |
|---|---|---|
| MDCG 2022-4 | MDCG | Systems and procedure packs; reprocessing of single-use devices |
Class I devices
| Document | Source | Summary |
|---|---|---|
| MDCG 2021-22 | MDCG | Class I device registration obligations in EUDAMED |
| MDCG 2021-3 | MDCG | Custom-made Class I devices |