The announcement clarifies the status of certified documents, product registration and movement requirements relating to medical devices in the context of the transition to the Regulation. The announcement states due dates for the certified documents and new product registrations that take into consideration the Product Tracking System registrations.

The announcement also sets out rules for the status of:

  • Products certified by British notified bodies.
  • Products with certified documents which are transferred or not transferred to a notified body in an EU member country.
  • Products which have been updated in the Regulation.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.