Working groups and taskforces

Groups

Competences/Terms of reference

Chair

Participants

Medical Devices Expert Group (MDEG)



MDEG is a group of Member States, industry and other stakeholder representatives in the area of medical devices for the implementation of the directive. This group is the umbrella group for other working groups in the field and co-ordinates and oversees their activities.

In closed session MDEG is a forum to discuss all issues relating to the implementation of the medical device directives with Member State Competent Authorities.

EC

Competent Authorities, Industry (trade associations), Notified Bodies, Standardisation Bodies, COM services

MDEG also meets in closed sessions including Competent Authorities only.

Competent Authority (CA) meetings

The rotating Presidency of the Union traditionally organizes a Competent Authority meeting, in which the competent national authorities of the Union, candidate countries, EFTA and the European Commission discuss overall policy issues.

By respective Presidency

Competent Authorities, COM services

Vigilance

Scope: all issues concerning adverse event reporting.

The Vigilance Working Group is the forum where all interested parties exchange guidance, information, discuss actual adverse event cases, review current reporting practices and prepare input into the Eudamed database. The Vigilance group also acts as the GHTF-Study Group 2 "Mirror Group".

EC

Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services

Classification and Borderline

The purpose of the group is to discuss questions of:

Borderline: Is a given product a medical device or something else (i.e. medicine, cosmetic, biocide).

Classification: Matters concerning in which class a given medical device or medical device group needs to fall are discussed.

The group typically uses an 'Enquiry Template' to communicate questions to all Member States and gather responses. Responses are collated and presented at the meeting by the Member State originator, including their proposed consensus opinion based on the responses.

EC

Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services

Compliance and Enforcement Group (COEN)

The Compliance and Enforcement Group is to focus on the scope and better co-ordination of the enforcement activities by Member States, and consider how communications and co-operation between Member States can be made more effective and efficient.

AT

Competent Authorities (experts), COM services

Notified Body Operations Group

(NBOG)

The Notified Body Operations Group's aim is to contribute to improvement of the overall performance of Notified Bodies in the medical devices sector by primarily identifying and promulgating examples of best practice to be adopted by both Notified Bodies and those organisations responsible for their designation and control.

They review the "recommendations" issued by the NB-MED (group where all the EU Notified Bodies participate) and act as a "Mirror Group" following GHTF work relating to Notified Bodies.

DE

Competent Authorities/designating Authorities (experts), COM services (On focal points, a Notified Body representative can be invited to participate)

IVD Technical Group

The IVD Technical Group aims to supply the Commission, MDEG and other Working Groups with technical and specific input, for example by the drafting of CTS and examination of other specific or general issues, to aid in the uniform interpretation and implementation of the IVD Directive.

UK

Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services

Working Group on Clinical Investigation and Evaluation(CIE)




To develop and promote homogenous interpretation and implementation of European Medical Device Directives with regard to clinical evaluation and investigation, incl. PMCF, and to enhance related cooperation between MS's.

To explore whether Medical Device legislation on clinical evidence is appropriate/adequate/sufficient, to advice on eventual further development and to consider the need for/develop guidance on specific issues.

To serve as European Mirror Group for GHTF SG 5.

To monitor the relevant EU and international regulatory/normative environment and European/ISO Standardisation in the clinical area.

To support the Strategic Development of the sector in the clinicals.

To act as a forum for information on clinical investigations.

AT

Competent Authorities (experts), Industry, Notified Bodies, representatives of the medical professions, COM services

Electronic Labelling Working Group

To consider and prepare guidance on the circumstances and manner in which the Instructions For Use (IFU) and other information required for the safe and proper use of medical devices can be provided, including any limitations and safeguards that should be applied. Such guidance will form the basis for possible Community measures on e-labelling.

EC

Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services

New & Emerging Technologies Working Group (NET)


Purpose of N&ET Working Group:

Identify new and emerging technologies in the area of medical devices.

Consider the adequacy of the existing devices regulatory regime in relation to those technologies. Where shortcomings are identified make recommendations to the Medical Device Expert Group to solve them by either the production of guidance or regulatory change.

Comment on relevant issues in connection to new and emerging technologies in other areas, as far as it affects medical devices.

NL-UK

Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services

Eudamed Working Group

To advice on all issues related to the implementation of the Eudamed database.

EC

Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services

NB-MED

To share experience and exchange views on application of conformity assessment procedures with the aim of contributing to a better understanding and consistent application of requirements and procedures.

To draft technical recommendations on matters relating to conformity assessment and build a consensus.

To advise the Commission, at its request, on subjects related to application of the medical device directives.

To consider, and if necessary, draft reports on ethical aspects of notified bodie's activities.

To ensure consistency with standardization work at European level.

To keep informed o harmonisation activities at European level.

Notified Bodies (NL)

Notified Bodies, Competent Authorities (experts), Industry, Standardisation Bodies, COM services