A large-scale inspection campaign on dental implants, carried out by the French Ministry of Health (ANSM) Inspection Department, took place in 16 manufacturers’ and 16 distributors’ facilities.
The objective of this campaign was to ensure that the market operators fully respected EU and French regulatory requirements applicable to marketing and distribution of dental implants.
Inspections have shown that certain points are frequently subject of deviations.
The attention of Manufacturers is drawn to the:
– compliance of Technical files, in particular with regard to the assessments and tests to be carried out for the demonstration of biocompatibility; (Obelis has a dedicated Technical file review service!)
– formalization of Validation processes for obtaining and controlling the sterility of the devices;
– Quality Management System, in particular with regard to audits and contracts with suppliers or subcontractors; (Obelis can review and help you improving your QMS!)
– Notification/ Registration activity and CE conformity certifications and declarations. (Obelis Notifies and Registers devices on your behalf!)
Distributors must ensure:
– control of EC Declarations of Conformity and presentation of CE certificates of conformity;
– management of the materio-vigilance and the treatment of complaints;
– verification of the information on the labels and instructions for use
– control of the traceability of the implants.
Several administrative measures, targeting four operators, were taken during this campaign: two health police decisions and two injunctions. A reminder of the law was sent to the three operators.
Should you need more information on all EU and French rules for Dental implants marketing, especially considering the new EU medical Device Regulation, feel free to use our experts knowledge! We are fully capable of teaching you how to be fully compliant and have solid documentation in case of any CA inspection. And, thanks to our new dedicated Post Market Activities department, we can also take care directly of any post-marketing issue you may face. Contact us!
23/12/2019 Davide Turchi
DPM of RA&QA Department
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