The European Commission has issued a document that is highly relevant for manufacturers of reusable and resterilizable medical devices.
The background for issuing this document are deficiencies in the documentation of many products belonging to this device group. Although class I and IIa medical devices may be placed on the market in Europe without IFU, numerous manufacturers make inappropriate use of this option.
The medical devices directive (MDD) essential requirements require the IFU to include information related to the device reuse (e.g. cleaning, disinfection, sterilization). The described methods must be properly validated. Reference standards are EN ISO 17644 and EN 14937.
The checklist that has now been published is intended to bring more clarity on what can be expected of manufacturers in terms of IFU contents and the corresponding validation. This point is highly relevant because it can be expected that competent authorities will have a closer eye on products like reusable surgical instruments in the extended transition period until May 25, 2024.
Sources: Medtech Insight (an Informa product), European Commission