Regulation 2024/1860 Published
July 17, 2024
The requirement to notify of foreseeable supply disruptions (including discontinuation) goes into effect, under Article 10 of the MDR/IVDR.
Key Points:
- This is required when it is reasonably foreseeable that a supply interruption may result in serious harm or a risk of serious harm to patients or public health, in one or more Member States.
- At least six (6) months’ advance notice must be given, before the anticipated interruption.
- The manufacturer should notify all relevant parties. These include, but are not limited to, their (or their Authorized Representative’s) Competent Authority, importers, distributors, health institutions, and healthcare professionals.