Europe – Instructions For Use for reusable and re‐sterilisable Medical Devices

The mission of the Compliance and Enforcement Group (COEN) is to provide for the exchange of information between Competent Authorities (CA) responsible for market surveillance (MS) of medical devices (MD) and to coordinate their enforcement activities.

Following a number of individual actions of CA that revealed major non-conformities related to the instructions for use (IFU) of resterilisable medical devices (RMD) the COEN created the “IFU Working Group” to address this issue.

A harmonised standard exists for the sterilisation of medical devices to facilitate manufacturers in their compliance with section 13 of the essential requirements as set in Annex I of the medical device directive 93/42/EEC (MDD) namely EN ISO 17664 “Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilisable medical devices”. However it became clear in the course of the project that those involved in this particular sector urgently needed user-friendly guidance to allow them to assess safety and fitness for the purpose of RMD in addition to the harmonised standard. Consequently the present document is intended for all individuals and organisations involved in this sector, but more specifically targeting manufacturers, end users and procurement officers…