The European Commission has published a draft regulation setting out rules for the application of the Medical Device Regulation (MDR, 2017/745) with regard to common specifications for the reprocessing of single-use medical devices.
Whether or not such reprocessing is permitted is in the gift of the member states. Some, such as France, have outright banned the practice while others, such as Germany, have been supportive of companies providing these services. In the UK the practice is strongly advised against though not specifically forbidden. The latest MHRA document on ‘Single-use medical devices: implications and consequences of reuse’, was issued in December 2018. It draws attention to the hazards and risks associated with reprocessing and reusing single-use medical devices. The paper also covers the legal issues and regulatory requirements of such actions as well as considering the implications of damage to the materials or construction of the device and inadequate decontamination procedures.
The draft regulation is intended to apply where a Member State has chosen to apply Article 17(3) of the MDR. Essentially, reprocessors have the same legal obligations as any other manufacturer and must satisfy requirements relating to risk management, traceability, labelling, packaging and incident reporting. They must also carry out analysis of the suitability of products for reprocessing, determine the maximum number of reprocessing cycles per device and be able to validate their procedures. In addition, where the reprocessing is carried out by an external organisation there needs to be a contract in place between the health institution and that external reprocessor.
Comments may be submitted until midnight on 20 August 2019.