At the end of July 2020 the European Commission published a guide to address the issue of frequent non-compliance with instructions for use (IFU) for reusable and re-sterilizable Medical Devices.
The guide has been drawn up by the Compliance and Enforcement Group (COEN).
Essentially, the document presents two check-lists that the Manufacturer must comply with in order to obtain a positive result in the conformity assessment of his reusable Medical Devices, before placing on the market.
Check-list based on ISO 17664 and ISO 14937
The first is a control check-list for IFU based partially on the EN ISO 17644 standard “Sterilization of Medical Devices – Information to be provided by the manufacturer for the processing of resterilisable Medical Devices”.
The second is a control check-list based on EN ISO 14937 for the assessment of the validation of the reconditioning of reusable Medical Devices, identified as: “Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for Medical Devices”.
Specifically, the control lists highlight several important aspects, such as cleaning and disinfection processes, sterilization and storage methods of devices and criteria for evaluation.
In conclusion, the two check-lists are useful because they provide the Manufacturer and other parties involved with the right tools to understand if their reusable Medical Devices are valid to be placed on the market.
Do you need more information?
Trust our Thema consultants!
Thanks to their professionalism and expertise, our experts are able to provide you with a range of information about it.
Discover all our services on www.thema-med.com !
Subscribe to our newsletter to stay updated on the latest news in the strategic-regulatory area and on Thema activities!
Contact us and discover what we can do for you!
Source:
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_checklists-iso-17664-14937_en.pdf
