In the event that a Certificate of Free Sale (CFS) is not issued by a reference country for medical devices classified as a Procedure Pack under the European Medical Device Regulation (EU MDR) 2017/745, the company shall be required to submit the following documents:

Certificate of Free Sale for each individual medical device included within the Procedure Pack.

CE Certificate for each individual medical device included within the Procedure Pack.

Declaration of Conformity for the Procedure Pack in accordance with Article 22 of the EU MDR 2017/745.

ISO 13485:2016 Certificate for the actual manufacturer of the medical devices.