The requirement to notify of foreseeable supply disruptions (including discontinuation) goes into effect, under Article 10(a) 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.