The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices…
Reprocessing vs Re-manufacturing
Presently, reprocessing single-use devices is not regulated at the EU level. Some individual countries, such as Germany, allow single-use devices to be reprocessed using the same standards that apply to reusable devices. Others countries, such as France, do not allow the practice, and many “do not have any specific regulations” on the subject.
The UK currently does not allow reprocessing of single-use devices; however, MHRA says that it has been approached by multiple manufacturers who “re-manufacture” and CE mark used single-use devices.
For the past two years, MHRA says it has been investigating re-manufacturers and “assessing their technical, regulatory and clinical processes.” Following its review, MHRA said it sees a distinction between re-manufactured and reprocessed single-use devices.
In its draft guidance, MHRA says re-manufactured single-use devices must conform to the relevant medical device directive(s), acquire a CE mark, and satisfy the requirements of a notified body assessing the product.
MHRA also says that Class I devices should not be re-manufactured as “there would be no external or independent assessment of CE-mark compliance.” When a device is re-manufactured multiple times, it should always be done by the same company. Remanufacturers must also validate the number of times a device can be re-manufactured before it must be disposed of.
Additionally, re-manufactured devices should retain all markings by the original manufacturer, as well as new markings by the re-manufacturer, including company name, address and serial number, and the “packaging and instructions for use must clearly state that this product has been re-manufactured from the original.
“The guidance also clarifies that the original manufacturer is not responsible for remanufactured products, and the re-manufacturer is responsible for post-market surveillance of any re-manufactured single-use device.
New EU Medical Device Legislation
MHRA also acknowledges that its guidance may need to be updated to reflect changes at the EU level related to single-use devices if new medical device legislation is adopted…