Chapter 7 Essential Mode
Article 78
The manufacturers engaged in producing only the items as listed in Annex, shall establish medical device file according to each type or device or series of devices. Each manufacturer shall also implement procedures for control of records, complaint handling as well as corrective and preventive actions.
The manufacturer mentioned in the preceding paragraph, may not be subject to other provisions of this Part of these Regulations, except for the provisions of Article 11, Article 12, Article 13, Article 47, Article 55, Article 63, Article 64, Article 69, Article 76 and Article 77.
Article 79
The Regulations shall be implemented from May 1st, 2021.