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Dialogue between interested parties

Dialogue between interested parties

The Directorate-General Internal Market, Industry, Entrepreneurship and SMEs works to strengthen the dialogue between those parties interested in the field of medical devices, including:

  • Supporting the activities of a wide range of working groups who identify and solve new issues with regard to the application of EU law;
  • Consulting the Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR)  when a scientific issue is raised;
  • Launching public consultations on major policy issues, such as the revision of the medical devices directives, the revision of directive 98/79 on in vitro diagnostic medical devices and the reprocessing of medical devices.
  • Maintaining a permanent dialogue with National Competent Authorities and stakeholders, including professional organisations, patients’ and medical practitioners’ organisations, standardisation bodies, Notified Bodies etc..
  • Cooperating with a number of policy and regulatory dialogues at international level;
  • Responding to the written questions relating to medical devices submitted by the Members of the European Parliament: Parliamentary Questions 

Scientific and technical assessment

The European Commission is not involved in the assessment of individual medical devices. However, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs closely follow new trends in science and technology, with a view to adapting the regulatory framework, as necessary.

Once a precise scientific question is raised, the Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) is consulted.

Previously, the SCENIHR has been consulted on the following issues:

The Working Group on New and Emerging Technologies in Medical Devices focuses on new technologies. These include devices used in relation to artificial organs or other advanced implants, minimal invasive surgery, telemedicine, radio-frequency identification, in vitro diagnostic devices or nanomaterials (70 kB).

Recent scientific opinions concerning Medical Devices

Ongoing Public Consultations

Find here the list of open public consultations

Working groups and taskforces

The following Working Groups contribute to the implementation of the Medical Devices Directives

Groups Competences/Terms of reference Chair Participants

Medical Devices Expert Group (MDEG)

Implementation of the medical device directives: This group is the umbrella group for other working groups in the medical devices field and coordinates 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 National Competent Authorities.

EC

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

MDEG also meets in closed sessions restricted to Competent Authorities.

Competent Authority (CA) meetings

The rotating Presidency of the Union traditionally organises a ‘competent authority meeting’, in which the national competent authorities of the Union, candidate countries, EFTA and the European Commission, discuss overall policy issues.

By respective Presidency

Competent Authorities, COM services

Vigilance

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 for the Eudamed database.

EC

Competent Authorities, Industry,
Notified Bodies, Standardisation Bodies, COM services

Classification and Borderline


Borderline: Deciding if a given product a medical device or something else (i.e. medicine, cosmetic, biocide).
Classification: Matters related to the type of classification appropriate for a given medical device or medical device group 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 consensus opinion based on the responses.

EC

Competent Authorities, Industry,
Notified Bodies, Standardisation Bodies, COM services

Compliance and Enforcement Group (COEN)

Focuses on the scope and better co-ordination of enforcement activities by Competent Authorities. The Group considers how communications and cooperation between Competent Authorities can be made more effective and efficient.

AT

Competent Authorities, COM services

Notified Body Operations Group (NBOG)

Contributes to the improvement of the overall performance of Notified Bodies in the medical devices sector, It does so byidentifying and disseminating examples of best practice to be adopted by both Notified Bodies and those organisations responsible for their designation and control.
The Group also reviews the “recommendations” issued by the NB-MED (group where all the EU Notified Bodies participate)

DE

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

IVD Technical Group

Supplies the Commission, MDEG and other Working Groups with technical and specific input, for example by the drafting of Common Technical Specifications (CTS) and examination of other specific or general issues, to aid in the uniform interpretation and implementation of the IVD Directive.

UK

Competent Authorities, Industry,
Notified Bodies, Standardisation Bodies, COM services

Working Group on Clinical Investigation and Evaluation (CIE)

Develops and promotes homogenous interpretation and implementation of European Medical Device Directives with regard to clinical evaluation and investigation, incl. PMCF, and enhances related cooperation between Competent Authorities
Explores whether Medical Device legislation on clinical evidence is appropriate/adequate, to advise on eventual further development; considersthe need for development/guidance on specific issues;
Monitors the relevant EU and international regulatory/normative environment and European/ISO Standardisation in the clinical area;
Supports the Strategic Development of the sector in the clinical trials and acts as a forum for information on clinical investigations.

AT

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

Electronic Labelling Working Group

Considers and prepares 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; Safeguards what should be applied. Such guidance will form the basis for possible Community measures on e-labelling.

EC

Competent Authorities, Industry,
Notified Bodies, Standardisation Bodies, COM services

New & Emerging Technologies Working Group (NET)

Identifies new and emerging technologies in the area of medical devices;
Considers the adequacy of the existing devices regulatory regime in relation to those technologies; Where shortcomings are identified makes recommendations to the Medical Device Expert Group to solve them by either the production of guidance or regulatory change;
Comments on relevant issues in connection to new and emerging technologies in other areas, as far as it affects medical devices.

NL–PT

Competent Authorities Industry,
Notified Bodies, Standardisation Bodies, COM services

Eudamed Working Group

Advises on all issues related to the implementation of the Eudamed database.

EC

Competent Authorities Industry,
Notified Bodies, Standardisation Bodies, COM services

NB–MED

Shares experience and exchange of views on the application of conformity assessment procedures with the aim of contributing to a better understanding and consistent application of requirements and procedures;
Drafts technical recommendations on matters relating to conformity assessment and to move towards a consensus;
Advises the Commission, at its request, on subjects related to application of the medical device directives;
Considers, and if necessary, drafts reports on ethical aspects on the activities of notified bodies; .
Ensures consistency with standardisation work at European level.

Notified Bodies (NL)

Notified Bodies, Competent Authorities Industry,
Standardisation Bodies, COM services

Clinical Investigation and Evaluation

Legislation

Clinical investigations

  • Guidelines on Clinical investigation: a guide for manufacturers and notified bodies, MEDDEV 2.7/4 (183 kB)
  • Guide for Competent Authorities in making an assessment of clinical investigation; notification, MEDDEV 2.7/2 (37 kB)
  • Explanatory document for Compentent Authorities, manufacturers and sponsors: EUDAMED identifier system for Clinical Investigations (13 kB)
  • International standard. EN ISO 14155:2011.
    Harmonised standards give presumption of conformity with the essential requirements of a given directive. The use of standards is not mandatory, however, if other means of compliance are used it shall be demonstrated that the essential requirements are met. EN ISO 14155:2011 “Clinical investigation of medical devices for human subjects – Good clinical practice”, gives practical guidance on the conduct and reporting of clinical investigations. EN ISO 14155:2011 has been published in the Official Journal of the European Union (OJ C123 of 27 April 2012) and is therefore a harmonised standard.

Serious Adverse Event reporting during Clinical Investigation

  • Guidelines on clinical investigations: serious adverse event reporting under directives 90/385/EEC and 93/42/EC, MEDDEV 2.7/3 (166 kB)
  • MEDDEV 2.7/3 Appendix: SAE reporting form (87 kB)
  • Incidents occuring following the placing of devices on the market should be reported in accordance whith MEDDEV 2.12/1 (889 kB). This reporting obligation also includes incidents occuring during post market clinical investigation of CE marked devices used for the intended purpose.

Clinical Evaluation

GHTF Documents

Proposed and final documents from Clinical Safety/Performance – Study Group 5

Contact points

Clinical investigation contact points within the national competent authorities

Links

International Cooperation

Public safety and healthcare are among the main responsibilities of all governments. This is why the European Commission has engaged in a number of policy and regulatory dialogues with key trade partners of the EU,in the field of medical technology.

Discussions and exchanges of ideas have been pursued mainly with the US Food and Drug Administration (FDA), Japan Ministry of Health, Labour and Welfare (MHLW) , Health/Santé Canada, Australia Therapeutic Goods Administration (TGA), China Food and Drug Administration (SFDA) and China Quality Supervision, Inspection and Quarantine (AQSIQ). The regulatory dialogues on health technology is also active under political umbrellas such as the Transatlantic and Trade Agreement (T-TIP) with the USA, the Free Trade Agreement (FTA) with Japan or the Revised Mutual Recognition Agreement with Australia (Revised MRA).

The cooperation takes also place within a multilateral framework, the International Medical Device Regulators’ Forum (IMDRF). The IMDRF includes representatives from: Australia, Brazil, Canada, China, Japan, the Russian Federation, the USA and the World Health Organization (WHO) and other fora representatives as observers.

The active participation of Europe in IMDRF contributes to the definition of a global regulatory model for medical device and in vitro diagnostics (IVD) technology and the drafting of guidance documents agreed by consensus.

More detailed Information on the multilateral and bilateral policy and regulatory dialogues can be found under the following links:

IMDRF Ongoing Projects

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