EU Regulation 2017/745 introduced several changes regarding the classification of medical devices, particularly for reusable surgical instruments. These devices will now be classified as Class I Reusable (Ir). They will now be subject to review by a notified body for aspects related to the reuse of the device. This applies in particular to cleaning, disinfection, sterilization, maintenance, and functional testing, as well as the corresponding instructions for use.
As a reminder, under Directive 93/42/EEC, this type of device was classified as Class I and could be placed on the market by the manufacturer through “self-certification” without the involvement of a notified body.
Manufacturers of reusable medical devices are responsible for validating the reprocessing of the devices. They must provide reprocessing instructions prior to the use or reuse of a device. These requirements are already addressed by manufacturers of Class II and III reusable medical devices, as they are subject to third-party evaluation. Manufacturers of Class Ire medical devices must therefore also comply with these obligations if they are not already addressed in their technical documentation and quality system.
In fact, the general safety and performance requirements (Article 23.4.n of Annex I to Regulation (EU) 2017/45) stipulate that the instructions for use must contain:
“If the device is reusable, information regarding the appropriate procedures to enable its reuse, including cleaning, disinfection, packaging, and, where applicable, the validated sterilization method appropriate for the Member State or Member States in which the device was placed on the market. Information shall be provided to determine when a device should no longer be reused, such as signs of material degradation or the maximum number of permissible reuses.”
Compliance with these requirements can be ensured by adhering to the following standards:
- EN ISO 17644 “Information on the processing of medical devices to be provided by the device manufacturer” and
- EN ISO 14937 “General requirements for the characterization of a sterilizing agent and for the development, validation, and routine verification of a sterilization process for medical devices.”
To facilitate understanding of these standards and to guide manufacturers through the validation and drafting of the instructions for use, the European Commission has published a checklist developed by the COEN Working Group. This checklist serves as a guide for drafting IFUs (based on the EN ISO 17644 standard) as well as for evaluating the validation of reprocessing procedures for reusable and re-sterilizable medical devices (based on the EN ISO 14937 standard).
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_checklists-iso-17664-14937_en.pdf