The EU Compliance and Enforcement Group (COEN) recently released a new guidance document that provides information to the industry on how to design their instructions for use for re-usable and re-sterilizable devices. This new guidance document explains the EC’s view on the applicability of EN ISO 17664 “Sterilization of medical devices -Information to be provided by the manufacturer for the processing of re-sterilizable medical devices” which is a harmonized standard to the EU MDD.1
User reports and market surveillance have shown that reusable and re-sterilizable medical devices do not contain an IFU. This is mainly due to the interpretation of rule 6 in Annex 1 that allows for class I devices to omit IFU “if they can be used safely without any such instructions”; and a majority of the reusable and re-sterilizable devices fall under class I.1 However, section 13.6h of Annex 1 requires that if the device is reusable, the instructions for use (IFU) must provide information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device to be resterilized.1
As part of this guidance document, the commission provides a checklist that follows EN ISO 17664, that will help the industry to design their IFUs for reusable devices to comply with ISO 17664.1
The checklist contains the following elements and can be accessed here: 2 https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_checklists-iso-17664-14937_en.pdf
- General description of IFU
- Information about cleaning, disinfection, and sterilization of the device
- Cleaning and disinfection processes
- Drying processes
- Inspection, maintenance, testing and packaging
- Sterilization and storage
- Human factors such as the training and knowledge of the users
- Accessories utilized
- Tolerance of reprocessing cycles
Have questions or need help in complying with the new requirements? Call us today at 248-987-4497 or email us at info@emmainternational.com.
1Compliance and Enforcement Group (COEN) (July 2020) Instructions For Use for reusable and re‐sterilizable Medical Devices retrieved from https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_checklists-iso-17664-14937_en.pdf on 07/29/2020.
2Emergo (July 2020) European regulators publish Instructions for Use checklist for reusable medical devices retrieved from https://www.emergobyul.com/blog/2020/07/european-regulators-publish-instructions-use-checklist-reusable-medical-devices on 07/29/2020
