Member States Endorse COMBINE Program for Medical Devices

Member States have officially endorsed the COMBINE program, a significant initiative aimed at streamlining the combined studies of medicines and medical devices. This program involves seven cross-sector projects that foster collaboration among national authorities, the European Medicines Agency, ethics committees, and various stakeholders.

Key goals of the COMBINE program

These include:

• • Establishing a single assessment process for multi-country studies.
  • Harmonizing adverse event reporting across different jurisdictions.

The endorsement of this program is a crucial step towards enhancing efficiency and consistency in clinical trials and medical device studies across Europe.

For more detailed information, the strategy is available on the Commission’s webpage: Combined studies and COMBINE strategy

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