siseturg, tööstus, ettevõtlus ja VKEd

Dialogue with interested parties

Dialogue with interested parties

The Directorate-General Internal Market, Industry, Entrepreneurship and SMEs encourages dialogue on medical devices. This includes

  • responding to written questions on medical devices from Members of the European Parliament
  • maintaining a permanent dialogue with national competent authorities, MDCG, CAMD and stakeholders, including professional organisations, patients’ and medical practitioners’ organisations, standardisation bodies and notified bodies
  • supporting a wide range of working groups who identify and solve issues around the application of EU law
  • consulting the scientific committee on health, environmental and emerging risks (SCHEER) when a scientific issue is raised
  • launching public consultations on major policy issues
  • cooperating with a number of policy and regulatory dialogues at international level

Medical devices coordination group

The medical devices coordination group (the MDCG) is an expert group. It was established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Its members are experts representing competent authorities of the EU countries. The MDCG advises and assists the Commission and EU countries in the implementation of both Regulations. The MDCG operates in accordance with the horizontal rules on the creation and operation of Commission expert groups. It's registered in the register of Commission expert groups and other similar entities under the code X03565.

The MDCG has 11 working groups

1. Notified bodies oversight (NBO)

Notified bodies oversight (NBO) – Terms of reference.

 

Chair

Participants

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.

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

Advises the Commission, at its request, in matters concerning the coordination group of notified bodies.

COM

CA/DA

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

 

 

2. Standards

Standards – terms of reference.

 

Chair

Participants

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 related to common specifications. Harmonisation of standards to MDR and IVDR.

EC

COM, CA, SH

3. Clinical investigation and evaluation (CIE)

Clinical investigation and evaluation (CIE) – terms of reference.

 

Chair

Participants

Develops and promotes homogenous interpretation and implementation with regard to clinical evaluation and investigation.

Supports other working groups on clinical investigations and evaluation issues.

EC

COM, CA, SH

4. Post-market surveillance and vigilance (PMSV)

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

 

Chair

Participants

Issues concerning incident reporting. The working group is the forum where CAs exchange guidance, information, discuss actual incident cases, review current reporting practices. It includes measures to improve the reporting behaviour of all actors. It provides advice on matters related to device registries.

EC

COM, CA, SH

5. Market surveillance

Market Surveillance – terms of reference.

 

Chair

Participants

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

EC

COM, CA

6. Borderline and classification (B&C)

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

 

Chair

Participants

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.

EC

COM, CA, SH

7. New technologies

New technologies – terms of reference.

 

Chair

Participants

Advises on software, cybersecurity, and other issues related to new technologies.

Works closely with the B&C 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. Works closely with the IMDRF group.

EC

COM, CA, SH

8. EUDAMED

EUDAMED – see the register of expert groups under the code E01309.

 

Chair

Participants

Facilitates the implementation of the EUDAMED database.

EC

COM, CA, SH

9. Unique device identification (UDI)

Unique device identification (UDI) – terms of reference.

 

Chair

Participants

Facilitates the implementation of UDI. The group works in close cooperation with EUDAMED WG for those aspects which relate to 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).

EC

COM, CA, SH

10. International matters

International matters – terms of reference.

 

Chair

Participants

Prepares a common European view on IMDRF issues and discuss other international issues.

Monitors international regulation trends.

EC

COM, CA, SH

11. In vitro diagnostic medical devices (IVD)

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

 

Chair

Participants

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

EC

COM, CA, SH

Competent authorities for medical devices (CAMD)

The CAMD facilitates the implementation and the enforcement of the MDR and IVDR. It also provides training and exchange of best practices. The CAMD meetings are also networking events and may tackle medical device issues beyond the MDR and IVDR.

NB-MED

  • Allows notified bodies to share experience and exchange views on the application of conformity assessment procedures.
  • Drafts technical recommendations and creates consensus on matters relating to conformity assessment.
  • Advises the Commission, at its request, on medical device legislation.
  • Drafts reports on ethical aspects of the activities of notified bodies.
  • Ensures consistency with standardisation work at European level.