The EU’s pledge to ensure that only safe and performant medical devices are placed on the EU market and provided to patients involve engaging with international regulators to set high standards and promote regulatory convergence.
The European Commission is active in a number of policy and regulatory dialogues with EU’s key partners in medical technologies. This cooperation takes place in both bi-lateral and multi-lateral forums.
The European Commission’s main partners in bi-lateral exchanges are the US Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), Health/Santé Canada, Japan’s Ministry of Health, Labour and Welfare (MHLW), Korea’s Ministry of Food and Drug Safety (MFDS) and the World Health Organization (WHO).
Regulatory discussions regarding medical technologies are also pursed under political umbrellas such as the EU-US Trade and Technology Council, the Free Trade Agreement (FTA) with Japan or the Revised Mutual Recognition Agreement with Australia and New Zealand (Revised MRA).
In addition to the above, the EU maintains an active dialogue with Taiwan, India, Israel, China, and many other countries.
International Medical Device Regulators Forum
Cooperation also takes place within multi-lateral forums, such as the International Medical Device Regulators Forum (IMDRF). The IMDRF was established in October 2011 and is a forum for medical device regulators from different jurisdictions who have agreed to work together to advance international regulatory harmonisation and convergence in the field of medical devices. The IMDRF builds on the strong work foundation of the Global Harmonization Task Force on Medical Devices (GHTF), which was established in 1992 with the EU as one of the founding members.
EU chairs IMDRF in 2023
The EU undertakes the rotating role of Chair of the IMDRF Management Committee for 2023. The European Commission will act as the Chair on behalf of the EU.
This represents a unique occasion for the EU to develop stronger collaborations with other jurisdictions, facilitate the growth and exports of EU manufacturers and aim at ensuring the same high level of protection of public health by setting the highest standards jointly with IMDRF regulators. The EU’s participation in IMDRF increases international medical device regulatory convergence. Therefore, the requirements and approaches become more aligned by adopting the same technical documents, standards, scientific principles and similar regulatory practices and procedures.
The EU will host a series of IMDRF meetings in 2023. Some of the sessions will be open to the public. In this context, regulators, industry, healthcare professionals and various interested actors will have the opportunity to discuss about a wide variety of topics concerning medical devices.
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More info on IMDRF
The IMDRF Management Committee includes representatives from the EU (European Commission and representatives of EU Member States), Australia, Brazil, Canada, China, Japan, Singapore, South Korea and the US. The World Health Organization (WHO) and Argentina are official observers to the IMDRF.
The IMDRF maintains working relationships with other international entities and regional organisations in order to foster global convergence. By pooling resources and expertise, the IMDRF aims to promote high standards for safe and performant medical devices globally.
The work of the IMDRF represents the regulatory golden standard in the field, from which many non-participating authorities draw inspiration when establishing their national regulatory considerations.
IMDRF produces guidance documents aiming at the facilitation of the work of regulators and economic operators at a global level.
Working Groups are established by the Management Committee and operate under targeted mandates on specific activities identified in the IMDRF five-year strategic plan. The EU is active in all the following IMDRF working groups:
- Artificial Intelligence Medical Devices
- Adverse Event Terminology
- Good Regulatory Review Practices
- Medical Device Cybersecurity Guide
- Personalized Medical Devices
- Quality Management Systems
- Regulated Product Submission
- Software as a Medical Device
IMDRF member competent authorities
- Australia, Therapeutic Goods Administration (TGA)
- Brazil, Brazilian Health Regulatory Agency (Anvisa)
- Canada, Health Canada
- China, National Medical Products Administration (NMPA)
- European Union (European Commission, DG SANTE)
- Japan, Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare (MHLW)
- Singapore, Health Sciences Authority
- South Korea, Ministry of Food and Drug Safety
- U.S.A., U.S. Food and Drug Administration (FDA)