About The Medical Research Ethics Committees (MREC)

The MREC was established as an institution under the Ministry of Health in 2021. With the implementation of the regulations on Medical Equipment and Clinical Drug Trials, a total of 3 new Medical Research Ethics Committees were established. Their primary task is to handle applications for clinical trials with drugs (CTR) and tests of medical equipment (MDR) in collaboration with The Danish Medicines Agency.

MREC's tasks include

  • Processing reports of clinical trials of medical equipment.
  • Following research developments within clinical trials of medical equipment, 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 for approval of a clinical trial of medical equipment 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.
Last updated 01-02-2024

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