MEDDEV, NB-MED recommendations, EC Blue Guide & forms
MEDDEV and NB-MED documents were produced under the old MDD/AIMDD/IVDD framework (pre-2017). While some retain value as interpretive background, they must be read critically in the context of MDR/IVDR requirements. MDR/IVDR supersede these older documents where inconsistent. For current compliance questions, always refer to MDCG guidance first, then to MEDDEV only where MDCG provides no explicit guidance.
MEDDEV guidance documents
MEDDEV documents were produced by the European Commission's Working Group on Medical Devices to assist implementation of the old MDD/AIMDD/IVDD directives. Many have not been formally updated for MDR/IVDR but remain referenced by the industry and notified bodies as baseline guidance.
Key MEDDEV documents still referenced under MDR/IVDR
| Document | Title | Status under MDR |
|---|---|---|
| MEDDEV 2.1/3 rev 3 (2010) | Borderlines with medicinal products | Superseded in part by MDCG 2022-5 — use MDCG instead |
| MEDDEV 2.7/1 rev 4 (2016) | Clinical evaluation: a guide for manufacturers | Largely superseded by MDCG 2020-5 — MDCG takes precedence |
| MEDDEV 2.12/1 rev 8 (2013) | Guidelines on a medical devices vigilance system | Superseded by MDR Art. 87–92 and MDCG 2023-3 |
| MEDDEV 2.12/2 rev 2 (2012) | Post market clinical follow-up studies | Superseded by MDCG 2020-7 |
| MEDDEV 2.4/1 rev 9 (2010) | Classification of medical devices | Largely superseded by MDCG classification guidance |
⚠️ Do not rely on MEDDEV documents where MDCG guidance covers the same topic. MDCG guidance reflects current MDR/IVDR requirements and supersedes MEDDEV guidance where there is a conflict. Always prioritise MDCG documents for compliance interpretation.
All MEDDEV documents are available on the European Commission DG SANTE website under the "Old Guidance" section.
NB-MED recommendations
NB-MED was the coordination body for notified bodies under the old directives. NB-MED recommendations addressed practical conformity assessment questions.
Under MDR/IVDR, notified body coordination is handled by the MDCG and notified body Joint Assessment Teams (JATs). NB-MED recommendations are historical documents only and should be replaced by current MDCG guidance for MDR/IVDR compliance.
They remain useful as:
- Historical context for why certain requirements exist
- Background reading on conformity assessment best practices that pre-date MDR
NB-MED documents are archived on the TEAM-NB website (team-nb.org).
TEAM-NB position papers
TEAM-NB (European Association of Notified Bodies for Medical Devices) is the current coordinating body for MDR/IVDR notified bodies. It publishes:
- Position papers on specific MDR/IVDR interpretation questions
- Operational guidance for NB assessment activities
- NB consensus documents on topics such as technical documentation review
TEAM-NB documents are available at team-nb.org. They are not binding on individual NBs but reflect consensus practice.
EC Blue Guide — market surveillance
The EU Blue Guide on the Implementation of EU Product Rules (commonly called the "Blue Guide") is a Commission guidance document explaining the general EU New Approach framework for product regulation. It is relevant to MDR/IVDR because:
- It explains how CE marking, Declarations of Conformity, and notified bodies work across all EU product regulations (not just medical devices)
- It provides guidance on economic operator obligations applicable broadly
- It explains market surveillance principles and NCA powers
The 2022 edition of the Blue Guide is available on the European Commission website.
Forms & application links
Key forms and application portals for EU medical device regulation:
| Purpose | Where to find it |
|---|---|
| EUDAMED — all registrations and vigilance reports | ec.europa.eu/tools/eudamed |
| Clinical investigation application (national) | Relevant NCA website per member state |
| NCA borderline query | Relevant NCA website per member state |
| Notified body selection and application | NANDO database (ec.europa.eu/growth/tools-databases/nando) — select NB then contact directly |
| MDCG guidance documents | health.ec.europa.eu/medical-devices-sector |
| EUR-Lex — official legal texts | eur-lex.europa.eu |
| Harmonised standards list | OJ C series; also via ec.europa.eu/growth/single-market/european-standards |
Related pages
- MDCG guidance by topic
- Guidance by device class
- Notified bodies — NANDO database
- How to read EU legislation
Access them at: https://health.ec.europa.eu/medical-devices-sector/new-regulations/mdcg-endorsed-documents-and-other-guidance-and-documents_en (select "MEDDEV guidance" tab).