Guides MEDDEV pour dispositifs médicaux

Les guides MEDDEV indiquent, de façon pratique, comment mettre en œuvre les Directives applicables aux dispositifs médicaux :

• Directive 93/42/CEE relative aux dispositifs médicaux (DM),
• Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro (DMDIV) et
• Directive 90/385/CEE relative à la mise sur le marché des dispositifs médicaux implantables actifs (DMIA).

Avec l'entrée en vigueur des Règlements (UE) 2017/745 et 2017/746, respectivement relatifs aux dispositifs médicaux (DM et DMIA) et aux dispositifs médicaux de diagnostic in vitro (DMDIV), ces guides sont progressivement remplacés par des guides MDCG.

Dans ce contexte, le guide MEDDEV considéré reste applicable tant qu'il n'a pas été remplacé par un guide MDCG.

Cette page vous indique les guides MEDDEV qui sont encore diffusés par la Commission européenne en début d'année 2024.

Liste des guides MEDDEV

MEDDEV 2.1/1

Guidance document – Medical Devices – Definitions of "medical devices", "accessory" and "manufacturer"

MEDDEV 2.1/2

Guidance document – Medical Devices – Field of application of directive 90/385/EEC (active implantable medical devices)

MEDDEV 2.1/2.1

Guidance document – Medical Devices – Field of application of directive 90/385/EEC (active implantable medical devices) – Treatment of computers used to program implantable pulse generators

MEDDEV 2.1/3

Guidance document – Medical Devices – Scope, field of application, definition – Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative

MEDDEV 2.1/4

Guidance document – Medical Devices – Interface with other directives – Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective equipment

MEDDEV 2.1/5

Guidance document – Medical Devices – Medical devices with a measuring function

MEDDEV 2.1/6

Guidance document – Medical Devices – Scope, field of application, definition – Qualification and Classification of stand alone software used in healthcare within the regulatory framework of medical devices

MEDDEV 2.2/1

Guidance document – Medical Devices – Essential requirements – Electromagnetic Compatibility (EMC) requirements

MEDDEV 2.2/3

Guidance document – Medical Devices – Essential requirements – "Use by" date

MEDDEV 2.2/4

Guidance document – Medical Devices – Essential requirements – Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products

MEDDEV 2.5/3

Guidance document – Medical Devices – Conformity assessment procedure – Subcontracting quality systems related

MEDDEV 2.5/5

Guidance document – Medical Devices – Conformity assessment procedure – Translation procedure

MEDDEV 2.5/6

Guidance document – Medical Devices – Conformity assessment procedure – Homogenous batches (verification of manufacturers' products)

MEDDEV 2.5/7

Guidance document – Medical Devices – Conformity assessment procedure – Conformity assessment of breast implants

MEDDEV 2.5/9

Guidance document – Medical Devices – Conformity assessment procedure – Evaluation of medical devices incorporating products containing natural rubber latex

MEDDEV 2.5/10

Guidance document – Medical Devices – Conformity assessment procedure – Guideline for Authorised Representatives

MEDDEV 2.7/1

Guidance document – Medical Devices – Clinical investigation, clinical evaluation – Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC

MEDDEV 2.7/1 Appendix 1

Guidance document – Medical Devices – Clinical investigation, clinical evaluation – Clinical evaluation on coronary stents

MEDDEV 2.7/2

Guidance document – Medical Devices – Clinical investigation, clinical evaluation – Guide for Competent Authorities in making an assessment of clinical investigation notification under Directives 90/385/EEC and 93/42/EEC

MEDDEV 2.7/3

Guidance document – Medical Devices – Clinical investigation, clinical evaluation – Clinical investigations: serious adverse event reporting under Directives 90/385/EEC and 93/42/EEC

MEDDEV 2.7/4

Guidance document – Medical Devices – Clinical investigation, clinical evaluation – Guidelines on clinical investigations: a guide for manufacturers and notified bodies

MEDDEV 2.10/2

Guidance document – Medical Devices – Notified bodies – Designation and monitoring of notified bodies within the framework of EC directives on medical devices

MEDDEV 2.10/2 Attachment 1

Attachment 1 – Guidance on the preparation of a curriculum vitae for a Medical Device Expert

MEDDEV 2.10/2 Attachment 2

Attachment 2 – Example of a training course format

MEDDEV 2.10/2 Attachment 3

Attachment 3 – The responsibilities of the Notified Body under the Medical Device Directives Document

MEDDEV 2.10/2 Attachment 4

Attachment 4 – Special Rules of accreditation for Certification Bodies of Quality Systems (scope "Sterile Medical Devices")

MEDDEV 2.12/1

Guidance document – Medical Devices – Market surveillance – Guidelines on a Medical Devices Vigilance System

MEDDEV 2.12/1 Additional guidance

Guidance document – Medical Devices – Market surveillance – Additional guidance on Guidelines on a Medical Devices Vigilance System

MEDDEV 2.12/2

Guidance document – Medical Devices – Market surveillance – Post market clinical follow-up studies

MEDDEV 2.13

Commission communication on the application of the transitional provisions of Directive 93/42/EEC relating to medical devices

MEDDEV 2.14/1

Guidance document – In vitro diagnostic medical devices – Borderline and Classification issues. A guide for manufacturers and notified bodies

MEDDEV 2.14/2

Guidance document – In vitro diagnostic medical devices – Research Use Only products

MEDDEV 2.14/3

Guidance document – In vitro diagnostic medical devices – Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices

MEDDEV 2.14/4

Guidance document – In vitro diagnostic medical devices – CE marking of blood based in vitro diagnostic medical devices for variant Creutzfeldt-Jakob Disease (vCJD) based on detection of abnormal PrP (host protein)

MEDDEV 2.15

Guidance document – Committees/Working Groups contributing to the implementation of the Medical Device Directives

Pour en savoir plus

Les guides MEDDEV sont progressivement remplacés par des guides MDCG.

Pour bénéficier d'une présomption de conformité réglementaire, les opérateurs économiques concernés doivent inclure les exigences des guides MEDDEV qui leur sont applicables dans un système de management de la qualité (SMQ) prévu pour les dispositifs médicaux.