The requirements for importers and distributors under Article 13 and Article 14 of Regulation (EU) 2017/745 & Regulation (EU) 2017/746 have been widely discussed. In addition, however, the supervisory authorities impose further requirements that are not readily apparent:
- Documented procedures for product testing (according to Article 13(2)(a) to (d) and Article 14(2)(a) to (d))
- Documented procedures for handling non-compliant products (according to Article 13(1) and (7) and Article 14(4))
- Documented procedures for reporting products where a serious risk or falsification is suspected (according to Article 13(1) and (7) and Article 14(4))
- Documented procedures regarding the handling of complaints and reports (according to Article 13(8) and Article 14(5))
The supervisory authorities understand "procedures" as exclusively documented standard operating procedures. This means that even if importers and distributors are not obligated to implement a complete quality management system, they must demonstrate that their approach to fulfilling their obligations according to Regulation (EU) 2017/745 & Regulation (EU) 2017/746 is detailed in established processes.
To prevent losing track of all these requirements and to focus on your actual "business," please contact us so that we can work together to determine the necessary requirements and prepare you for inspections by the relevant supervisory authority. Do not hesitate to reach out to us for an informal discussion.