Medical Devices - Dialogue between interested parties

Medical Device Coordination Group Working Groups

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The Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector, from Notified Body oversight or standardisation to market surveillance, passing by international matters, new technologies and clinical investigation.

Its expertise originates from its division in 13 subgroups, which respectively provide advice and draft guidance on their expertise field.

The members of the subgroups are appointed by the Member States for a duration of 3 years. Stakeholders participate as observers and are appointed following a call for applications procedure also for a duration of 3 years.

They meet regularly with the EU Commission as Chair.

  1. Notified bodies oversight (NBO)
  2. Standards
  3. Clinical investigation and evaluation (CIE)
  4. Post-market surveillance and vigilance (PMSV)
  5. Market Surveillance (MS)
  6. Borderline and classification (B&C)
  7. New technologies
  8. EUDAMED
  9. Unique device identification (UDI)
  10. International matters
  11. In vitro diagnostic medical devices (IVD)
  12. Nomenclature
  13. “Annex XVI” products

1. Notified bodies oversight (NBO) – Terms of reference

The group shares experiences and exchanges views on issues relating to notified bodies (including activities laid down in Article 48 MDR/Article 44 IVDR) and the application of conformity assessment procedures with the aim of a consistent application of requirements and procedures

It drafts technical recommendations on matters relating to notified bodies and conformity assessment.

At the Commission’s request, it provides advice in matters concerning the coordination group of notified bodies.

Subgroup NB joint assessment: This subgroup might be established to support the joint assessment process.

Topics of interest: coordination of administrative practice, cooperation among authorities responsible for notified bodies (the designating authorities), conformity assessment activities.

Chair: European Commission

Participants: Competent authorities/designating authorities


2. Standards – Terms of reference

Discusses general issues relating to standardisation and, when necessary, coordinates proposals for development and use of technical and specific standard documents in diverse fields.

It might deal with horizontal policy issues also related to common specifications. Harmonisation of standards to MDR and IVDR.

Topics of interest: availability of harmonised standards also in the context of preparation of common specifications, cooperation with the European (CEN and Cenelec) and international (ISO and IEC) standardisation organisations, in particular in the context of the International Medical Device Regulators Forum (IMDRF), standardisation requests to the European standardisation organisations.

Chair: European Commission

Participants: Competent authorities, stakeholders


3. Clinical investigation and evaluation (CIE) – Terms of reference

Develops and promotes homogenous interpretation and implementation with regard to clinical evaluation and investigation. It also supports other working groups on clinical investigations and evaluation issues.

Topics of interest: common specifications in respect of the clinical investigation, evaluation and post-market clinical follow-up.

Chair: European Commission

Participants: Competent authorities, stakeholders


4. Post-market surveillance and vigilance (PMSV) – Terms of reference

Provides assistance to the MDCG on issues related to post-market surveillance, incident reporting and vigilance, with the aim of effective and harmonised  implementation of Regulation.

Develops and revise guidance documents, exchanges information, discusses actual incident cases, and reviews current reporting practices, including measures to improve the reporting behaviour of all actors.

Topics of interest: Reviewing of incident reporting practices. Development and updating of harmonised reporting forms for incidents, field safety corrective actions, field safety notices, periodic summary reports, trend reports and periodic safety update reports.

Chair: European Commission

Participants: Competent authorities, stakeholders


5. Market Surveillance (MS) – Terms of reference

Focuses on enforcement activities and administrative measures by competent authorities in relation to surveillance and control of devices put on the market.

Topics of interest: the application and implementation of the general safety and performance requirements, general obligations of economic operators, conformity assessment with regard to products that do not require the involvement of notified bodies.

Chair: European Commission

Participants: Competent authorities


6. Borderline and classification (B&C) – Terms of reference

Assists the MDCG with questions relating to the qualification of a product as a medical device or an accessory for a medical device (and an in vitro diagnostic medical device), as well as the qualification of products without an intended medical purpose.

Borderline

Advises on the qualification of a product as a medical device.

Classification

Matters related to the appropriate type of Classification for a given medical device, including IVDs. If needed, works closely with the IVD working group for IVD specific topics.

Topics of interest: practices as regards qualification and classification of devices, “Helsinki Procedure”.

Chair: European Commission

Participants: Competent authorities, stakeholders


7. New technologies – Terms of reference

Advises on issues related to application of new and emerging technologies to medical devices, including software, apps and cybersecurity.

Works closely with the Borderline and classification working group with regard to qualification and classification issues related to new technologies.

Identifies upcoming issues including new and emerging technologies in the area of medical devices including IVDs.

Considers the adequacy of the existing regulatory regime in relation to those issues and technologies. In order to resolve shortcomings the group makes recommendations to the MDCG and works closely with the IMDRF group.

Topics of interest: adequacy of the existing regulatory framework in relation to those issues and technologies, development of proposals for guidance and common specifications, electronic instructions of use of medical devices.

Chair: European Commission

Participants: Competent authorities, stakeholders


8. EUDAMED – Terms of reference

Facilitates the implementation of the EUDAMED database providing advice and coordinating as appropriate the work of other MDCG working groups when input to a specific EUDAMED module is required.

Topics of interest: management and maintenance of EUDAMED, advice on policy and technical matters including on the implementation and application of the relevant provisions of the MDR and IVDR.

Chair: European Commission

Participants: Competent authorities, stakeholders


9. Unique Device Identification (UDI) – Terms of reference

Facilitates the implementation of UDI. The group works in close cooperation with EUDAMED working group for aspects related with the functioning of the UDI database.

It provides advice for all matters related to device identification and traceability (including implementation of the relevant provisions on implant cards).

Topics of interest: all matters related to device identification and traceability, including implementation of the relevant provisions of the MDR on implant cards.

Chair: European Commission

Participants: Competent authorities, stakeholders


10. International matters – Terms of reference

Prepares a common European view on IMDRF issues and discuss other international issues related to medical devices and in-vitro diagnostic medical devices, in particular it monitors international regulation trends.

Topics of interest: formulation of common views and positions of EU Member States on harmonisation topics discussed within the IMDRF.

Chair: European Commission

Participants: Competent authorities, stakeholders


11. In vitro diagnostic medical devices (IVD) – Terms of reference

Develops and promotes homogenous interpretation and implementation with regard to IVD specific issues. Supports other working groups on IVD specific topics. In addition, it deals with clinical issues specific to IVDs, if needed in cooperation with the CIE WG.

Topics of interest: coordination of activities with other MDCG working groups as appropriate and, whenever needed, provides them with input on IVD specific aspects of their work (such as in the field of classification, performance studies, performance evaluation and post-market performance follow-up of IVDs).

Chair: European Commission

Participants: Competent authorities, stakeholders


12. Nomenclature – Terms of reference

Provides assistance on all implementation issues related to the medical device nomenclature with the aim to support the functioning of the future European database on medical devices (EUDAMED).

Topics of interest: matters related to the update and maintenance of the EU nomenclature, ways to use nomenclature in contexts other than UDI registration, such as market surveillance.

Chair: European Commission

Participants: Competent authorities, stakeholders


13. “Annex XVI” products – Terms of reference

Develops common specifications for those groups of products without an intended medical purpose that are listed in Regulation (EU) 2017/745 Annex XVI.

Topics of interest: the application and implementation of the general safety and performance requirements set out in Annex I of the MDR for Annex XVI devices; general obligations of economic operators with reference to Annex XVI devices; qualification of products and technical aspects.

Chair: European Commission

Participants: Competent authorities, stakeholders