Medical Device Coordination Group (MDCG) - Hoofdinhoud

Deze expertgroep [EU] i (nr. X03565) adviseert de Europese Commissie (Directoraat-generaal Gezondheid en Voedselveiligheid (SANTE) i) bij het opstellen van nieuwe wetgeving en nieuw beleid. Expertgroepen zijn samengesteld uit deskundigen van nationale overheden, vertegenwoordigers van belangenorganisaties en/of experts uit het bedrijfsleven.

1. Medical Device Coordination Group (MDCG)

Details

Abbreviation: MDCG

Policy Area: Public Health

Lead DG: DG Health and Food Safety

Type: Formal

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

Contact: -

Publication in RegExp: 10/01/2018

Creating Act: -

Last updated: 10/07/2023

Additional Information

Selection procedure: 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.

Rules of procedure: Rules of Procedure of the the Medical Device Coordination Group

MDCG Rules of Procedure.pdf (approx. 79 kb)

Other: Link to MDCG endorsed documents and other guidance

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

Subgroups

01 - Notified Bodies Oversight (NBO)

02 - Standards

03 - Clinical Investigation and Evaluation (CIE)

04 - Post-Market Surveillance and Vigilance (PMSV)

05 - Market Surveillance

06 - Borderline and Classification (B&C)

07 - New Technologies

08 - EUDAMED

09 - Unique Device Identification (UDI)

10 - International Matters


Type E - Other public entity
Name	Entity type	Countries/Areas represented	Categories	Status
Icelandic Medicines Agency	Other entities	Iceland	Public health	Observer

11 - In vitro Diagnostic Medical Devices (IVD)

12 - Nomenclature

13 - Annex XVI