Registre des groupes d'experts de la Commission et autres entités similaires

Français (fr)

Commission Européenne
>
Registre des groupes d'experts de la Commission et autres entités similaires
>
Détails du groupe

fr.cd.europa.button_altText_decrease_text

fr.cd.europa.button_altText_increase_text

Détails du groupe - Autre entité similaire
	Imprimer au format PDF
S'abonner à ce groupe

Détails

Information complémentaire

Réunions

Sous-groupes

Statistiques

Members

Nom:

Medical Device Coordination Group (X03565)

Abréviation:

MDCG

Politique sectorielle:

Santé publique

DG chef de file:

SANTE - DG Santé et sécurité alimentaire

DG associée:

JRC - Centre commun de recherche

Type:

Formel, Permanent

Portée:

Vaste

Mission:

MDCG provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746.

Tâche:

Aider la Commission à mettre en œuvre la législation, les programmes et les politiques actuels de l'Union

Assurer une coordination avec les États membres et procéder à des échanges de vues

Contact:

SANTE-MED-DEV@ec.europa.eu

Publication dans RegExp:

10 janv. 2018

Acte créateur:

Article 103(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC: "A Medical Device Coordination Group (‘MDCG’) is hereby established"

Lien vers un site Web:

https://ec.europa.eu/health/md_sector/overview_en

Dernière mise à jour:

19 févr. 2021

Appel à candidatures

Status:: Clôturé

CALL FOR APPLICATIONS FOR THE SELECTION OF OBSERVERS TO THE EUDAMED SUB-GROUP OF THE MEDICAL DEVICE COORDINATION GROUP

DG:: DG Santé et sécurité alimentaire
Domaine d'action:: Marché intérieur, Santé publique

Appel à candidatures

Status:: Clôturé

CALL FOR APPLICATIONS FOR THE SELECTION OF OBSERVERS TO THE ANNEX XVI SUB-GROUP OF THE MEDICAL DEVICE COORDINATION GROUP - This is an updated version of the call replacing the version published on 27/01/2020. Deadline for submission of applications is extended until 6 March 2020.

DG:: DG Santé et sécurité alimentaire
Domaine d'action:: Marché intérieur, Santé publique

Appel à candidatures

Status:: Clôturé

CALL FOR APPLICATIONS FOR THE SELECTION OF OBSERVERS TO THE NOMENCLATURE SUB-GROUP OF THE MEDICAL DEVICE COORDINATION GROUP

DG:: DG Marché intérieur, industrie, entrepreneuriat et PME
Domaine d'action:: Entreprises, Santé publique

Procédure de sélection (membres) Members of the MDCG are the competent authorities of the EU Member States. Subgroups consist of representatives of Member States and observers from the MDCG observer countries. Stakeholder organisations fulfilling certain criteria can participate as observers in most of the subgroups. The stakeholder organisations are appointed as observers after selection via public calls for applications (nr 195, 237 and 249). The Commission reserves the right to re-evaluate this participation subject to any new developments or invite on an ad hoc basis participants (who are not to be appointed as observers) when they have a specific expertise related to the specific meeting.

Appel à candidatures

Status:: Clôturé

Call for applications for the selection of observers to the subgroups of the Medical Device Coordination Group (MDCG)

DG:: DG Marché intérieur, industrie, entrepreneuriat et PME
Domaine d'action:: Marché intérieur

Règlement intérieur Rules of Procedure of the the Medical Device Coordination Group

MDCG Rules of Procedure.pdf

(approx. 79 kb)

Autre Terms of reference of the Medical Device Coordination Group (MDCG) --- (1) Terms of reference of the MDCG Working Group: Notified Bodies Oversight (NBO) --- (2) Terms of reference of the MDCG Working Group: Standards --- (3) Terms of reference of the MDCG Working Group: Clinical Investigation and Evaluation (CIE) --- (4) Terms of reference of the MDCG Working Group: Post-Market Surveillance and Vigilance (PMSV) --- (5) Terms of reference of the MDCG Working Group: Market Surveillance --- (6) Terms of reference of the MDCG Working Group: Borderline & Classification --- (7) Terms of reference of the MDCG Working Group: New Techonologies --- (8) Terms of reference of the MDCG Working Group: EUDAMED --- (9) Terms of reference of the MDCG Working Group: Unique Device Identification (UDI) and Device Traceability --- (10) Terms of reference of the MDCG Working Group: International Matters --- (11) Terms of reference of the MDCG Working Group: In-Vitro Diagnostic Medical Devices (IVD) --- (12) Terms of reference of the MDCG Working Group: Nomenclature --- (13) Terms of reference of the MDCG Working Group: Annex XVI ---

MDCG Terms of Reference.pdf

(approx. 43 kb)

ToR - WG 1 - NBO.pdf

(approx. 463 kb)

ToR - WG 2 - Standards.pdf

(approx. 464 kb)

ToR - WG 3 - CIE.pdf

(approx. 459 kb)

ToR - WG 4 - PMSV.pdf

(approx. 465 kb)

ToR - WG 5 - Market Surveillance.pdf

(approx. 463 kb)