The MREC was established as an institution under the Ministry of Health in 2021. With the implementation of Medical Device Regulation and Clinical Trials Regulation, a total of 3 new Medical Research Ethics Committees were established. With the National Life science-strategy of 2024, Committee number 4 was added.
MREC's tasks include
- Handle applications for clinical trials with drugs (CTR) and tests of medical devices (MDR) in collaboration with The Danish Medicines Agency.
- Following research developments within clinical trials of medical devices, products without a medical purpose, and generally in the health sector.
- Actively collaborating and coordinating task performance with relevant national and international authorities and organizations.
- Setting guidelines.
- Preparing the implementation of the regulation for clinical trials with drugs.
- Initiating initiatives under the Life Science Strategy.
The committees aim to
- Ensure that applicants experience a high level of service, qualified case processing, and adherence to processing time.
- Coordinate the work in the committees, ensuring consistency within the committee system.
- Ensure streamlined cooperation with The Danish Medicines Agency.
- Seek influence on the regulatory framework for scientific ethics in EU procedures for medical trials.
- Follow research developments in the health sector by being active in the clinical research environment nationally and internationally.