The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance permitting re-manufacturing of single-use devices (SUD) under certain conditions.
The MHRA recognised that that re-manufacturing is already widely used in a number of countries and that re-manufacturers would like to start placing their CE marked SUDs on the UK market. Re-manufacturing of class I devices is, however, excluded from the scope of the Guidance as these devices are subject to self-assessment prior to CE marking.
Pursuant to the Guidance, the re-manufacturer assumes full legal responsibility and liability for the re-manufactured device. Moreover, the intended use of the re-manufactured device must be the same as that of the device as originally produced.
The Guidance sets out the requirements that must be respected before a re-manufactured device can be placed on the EU market. These include:
- Assessment by the re-manufacturer of whether that the SUD is appropriate for re-manufacturing. Clinical and technical testing to establish the maximum number of times the device can be re-manufactured must also be conducted;
- Assessment by a notified body to confirm both, the validity and surety of all manufacturing processes and, compliance with the safety and performance provisions of the Medical Devices Directive (Directive 95/42 EEC);
- The device should be cleaned, disinfected and sterilized through tested and validated processes that are periodically audited;
- The re-manufactured device should bear a new CE mark;
- The packaging or device should carry the single-use symbol; and
- The packaging and instructions should clearly state that the SUD is re-manufactured and should identify the re-manufacturer.
The post-market surveillance responsibilities of the re-manufacturer include:
- Recording the number of times the device has been re-manufactured and to whom it was supplied;
- Reporting adverse events in accordance with applicable procedures and time limits;
- Monitoring problems associated with the original device to determine if these are relevant to the re-manufacturer device; and
- Managing product safety notification procedures or recall actions in relation to re-manufactured products.
The Guidance provides that re-manufactured devices should be supplied to healthcare institutions through closed loop contracts. Devices should be used only once, on an individual patient during a single procedure. The devices should then be returned to the original re-manufacturer in containers provided by them. Re-manufactured devices should not be resold to third parties or reprocessed. The healthcare facility is responsible for returning the devices to the original re-manufacturer, destroying or returning devices that have been re-manufactured the maximum number of times specified and reporting any issues with the device to the re-manufacturer.
The guidance distinguishes between re-manufactured SUDs and devices that are reprocessed or fully refurbished, which are limited to multi-use devices and for which separate guidance applies.