The Competent Authorities for Medical Devices (CAMD) working group recently published a Q&A document on free sales certificates (FSCs) under Regulation (EU) 2017/745 on medical devices (MDR).
A legalized FSC acts as a proof of compliance with the EU regulatory system. It is considered a fast and cost-efficient way to sell products in markets outside the European Union without an own regulatory system.
The Q&A document answers basic questions, e.g. who is responsible for issuance and to whom FSCs are typically issued. The paper also provides general information on the details that must be included in the application for an FSC.
Should you be interested in the document, please let us know and we will be happy to provide.