This amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the limited capacity of the notified bodies. Since its introduction in March, there have been some notable updates that manufacturers should be made aware of.
Advena has created a guidance document that will help you understand this new extension. The document explains the amendment in a very clear and concise way, incorporating flowcharts, timelines and a Q&A section to help you navigate through the intricacies of this new amendment. The guidance document also makes reference to the newly updated Q&A released by the EU Commission, including certain aspects such as the Notified Body Confirmation Letter and the Self-Declaration Template for manufacturers.
The guidance document can be accessed using the following link
