Jul 29, 2020

The European Commission has issued guidance originally devised in 2014 establishing checklists for developing instructions for use (IFU) as well as assessing validation of reprocessing procedures for reusable and re-sterilizable medical devices sold in the European Union.

The new guidelines include a checklist 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, as well as a checklist for assessment of manufactures’ validations of their reprocessing procedures based on the EN ISO 14937 standard, “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.”

IFU checklist for reusable medical devices

The Compliance and Enforcement Group (COEN), a predecessor of the Medical Device Coordinating Group (MDCG), developed the IFU checklist with the goal of reduce non-conformities pertaining to IFU of re-sterilizable devices; a large number of such devices are marketed in the EU without IFU documentation, either because they fall under Class I classification according to Medical Device Directive 93/42/EEC (MDD) rules and rely on self-declaration for CE Marking, or because manufacturers of some Class IIa re-sterilizable devices rely on exceptions noted in Annex 1 of the MDD allowing firms to omit inclusion of IFU information if their products “can be used safely without any instructions.”

The IFU checklist covers issues including:

  • General description of IFU
  • Information pertaining to cleaning, disinfection and sterilization of device
  • Cleaning and disinfection processes
  • Drying processes
  • Inspection, maintenance, testing and packaging
  • Sterilization and storage

The checklist is meant to provide a quick-reference snapshot of a manufacturer’s IFU-related processes, and where improvements may be required. Adherence to the full EN ISO 17664 standard is still required to demonstrate compliance, according to the guidance.

Checklist for assessment of validations of reprocessing procedures

The second checklist in the new guidance provides means to determine whether a manufacturer’s validation methods of its reprocessing procedures for reusable devices are sound.

The checklist was initially intended to help European Competent Authorities assess the validation of reprocessing procedures used by reusable device manufacturers. European regulators also anticipate that widespread utilization of the checklist will drive standardization of corresponding CE Mark Technical File sections, and that manufacturers, purchasers and other stakeholders will better understand CA criteria for validation assessment data.

Key areas of focus in the checklist, based partially on EN ISO 14937, include:

  • Device description
  • Validation plan
  • Preprocessing methods and equipment
  • Validation cleaning and disinfection methods
  • Validation of sterilization methods
  • Review of validation data

The guidance notes that the checklist for assessment of validations requires availability of validation data as well as a high level of expertise regarding reusable medical device processing in order to prove useful to Competent Authorities and other stakeholders.

Learn more about European CE Marking for medical devices at Emergo by UL:

  • European CE Marking strategy for medical device manufacturers
  • EU Medical Devices Regulation (MDR) preparation and resource center

Author

  • Stewart Eisenhart

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