Manufacturers, Authorised Representatives, Importers, and Distributorsof Medical Devices may not have yet fulfilled the obligations required by the MDR (EU) 2017/745 for Economic Operators.
It could be hard to keep the appointments with your Consultant because of the limits due to COVID-19.
For this reason, Thema experts suggest a rapid and effective last minute solution: MDR Emergency Kit, a kind of “S.O.S toolbox” in digital format, to solve the problem the fastest way possible.
Each Kit contains template and Technical documentation, Quality System documentation, letters of delegation and Quality Technical Agreements, that is, essential information and concrete answers to the main doubts about the MDR requirements.
By April 2, 2020 four different MDR Emergency Kit versions will be available. These versions have been thought for:
- Manufacturer (template letter of delegation of the Person Responsible for the compliance with the regulation, template Technical Documentation, Post-Market Surveillance procedures, Surveillance, Communications to the Regulatory Authorities, template information Note to the Dealer, Quality Technical Agreement Manufacturer/ Dealer).
- Authorised Representative (template letter of delegationof the Person Responsible for the compliance with the regulation, Post-Market Surveillance procedures, Surveillance, Communications to the Regulatory Authorities, Quality Technical Agreement Manufacturer/ Dealer).
- Importer (procedures for Non-Compliance, CAPA, Post-Market Surveillance, Communications to the Regulatory Authorities and to the Manufacturer, Controls in acceptance of finished devices, Controls in Acceptance module).
- Distributors (procedures for Non-Compliance, CAPA, Post-Market Surveillance, Communications to the Regulatory Authorities and to the Manufacturer, Controls in acceptance of finished devices, Controls in Acceptance module).
The Kits provide all the essential instruments to operate correctly in compliance with new obligations for Economic Operators.
This service allows to save time and costs, without risking being caught unprepared at the next application date of MDR.
In case of need for further Thema qualified support, our experts are available for additional and customized consulting services.
It’s already possible to book the MDR Emergency Kit. Contact us for more details and prices!
Phone 0542 643496 / sales@thema-med.com
