The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of 1 March 2022.
EMA is now responsible for monitoring medicine shortages that might lead to a crisis situation, as well as reporting shortages of critical medicines during a crisis. The Agency will also coordinate responses of EU / EEA countries to shortages of critical medical devices and in-vitro diagnostics in crisis situations, after an initial transition period up to 2 February 2023.
In preparation for the application of the new regulation, EMA has set up the permanent secretariat to support 12 medical device expert panels established by the Medical Devices Regulation in order to improve the safety of medical devices marketed in the EU / EEA. The expert panels, previously managed by the Commission’s Joint Research Centre, provide opinions and views to notified bodies on the scientific assessment of clinical and performance evaluations of certain high-risk medical devices and in-vitro diagnostics.
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