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Details

Additional Information

Meetings

Subgroups

Statistics

Members

Name:

Medical Device Coordination Group (X03565)

Abbreviation:

MDCG

Policy Area:

Public Health

Lead DG:

SANTE - DG Health and Food Safety

Associated DG:

JRC - Joint Research Centre

Type:

Formal, Permanent

Scope:

Broad

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.

Task:

Assist the Commission in relation to the implementation of existing Union legislation, programmes and policies

Coordinate with Member States, exchange of views

Contact:

SANTE-MED-DEV@ec.europa.eu

Publication in RegExp:

10 Jan 2018

Creating Act:

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"

Link to Website:

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

Last updated:

19 Feb 2021

Call for applications

Status:: Closed

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

DG:: DG Health and Food Safety
Policy Area:: Internal Market, Public Health

Call for applications

Status:: Closed

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 Health and Food Safety
Policy Area:: Internal Market, Public Health

Call for applications

Status:: Closed

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

DG:: DG Internal Market, Industry, Entrepreneurship and SMEs
Policy Area:: Enterprise, Public Health

Selection Procedure (members) 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.

Call for applications

Status:: Closed

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

DG:: DG Internal Market, Industry, Entrepreneurship and SMEs
Policy Area:: Internal Market

Internal Rules of Procedure Rules of Procedure of the the Medical Device Coordination Group

MDCG Rules of Procedure.pdf

(approx. 79 kb)

Other 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)

ToR - WG 6 - Borderline & Classiffication.pdf

(approx. 536 kb)

ToR - WG 7 - New Technologies.pdf

(approx. 463 kb)

ToR - WG 9 - UDI.pdf

(approx. 463 kb)

ToR - WG 10 - International Matters.pdf

(approx. 457 kb)

ToR - WG 11 - IVD.pdf

(approx. 525 kb)

ToR - WG 12 - Nomenclature.pdf

(approx. 223 kb)

ToR - WG 13 - Annex XVI.pdf

(approx. 87 kb)

ToR - WG 8 - EUDAMED.pdf

(approx. 217 kb)

Name

Duration

Status

01 - Notified Bodies Oversight (NBO)

permanent

Active

03 - Clinical Investigation and Evaluation (CIE)

permanent

Active

09 - Unique Device Identification (UDI)

permanent

Active

02 - Standards

permanent

Active

04 - Post-Market Surveillance and Vigilance (PMSV)

permanent

Active

07 - New Technologies

permanent

Active

05 - Market Surveillance

permanent

Active

12 - Nomenclature

Active

13 - Annex XVI

Active

06 - Borderline and Classification (B&C)

permanent

Active

08 - EUDAMED

Active

10 - International Matters

permanent

Active

11 - In vitro Diagnostic Medical Devices (IVD)

permanent

Active

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