MEDDEV, NB-MED recommendations, EC Blue Guide & forms
MEDDEV and NB-MED documents were produced under the old MDD/AIMDD/IVDD framework. While many remain relevant as interpretive guidance, they must be read in the context of MDR/IVDR requirements, which supersede them where inconsistent.
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| MEDDEV 2.1/3 rev 3 (2010) | Borderlines with medicinal products | Superseded in part by MDCG 2022-5 — use MDCG instead |
| MEDDEV 2.7/1 rev 4 (2016) | Clinical evaluation: a guide for manufacturers | Largely superseded by MDCG 2020-5 — MDCG takes precedence |
| MEDDEV 2.12/1 rev 8 (2013) | Guidelines on a medical devices vigilance system | Superseded by MDR Art. 87–92 and MDCG 2023-3 |
| MEDDEV 2.12/2 rev 2 (2012) | Post market clinical follow-up studies | Superseded by MDCG 2020-7 |
| MEDDEV 2.4/1 rev 9 (2010) | Classification of medical devices | Largely superseded by MDCG classification guidance |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 is current and aligned with MDR/IVDR requirements.
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 NB-MED recommendations are historical documents only and should be replaced by current MDCG guidance for MDR/IVDR compliance.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 |