United Kingdom, Medicines & Healthcare Products Regulatory Agency:

United Kingdom, Medicines & Healthcare Products Regulatory Agency:

Single-Use Medical Devices: UK Guidance on Re-Manufacturing (2016)

“…Single-use devices may be re-manufactured for use in the UK. However, the remanufacturer, prior to placing their device on the UK market or to putting it into service, should meet all relevant criteria under the appropriate medical devices directive and place a CE mark on their product to declare conformity with that directive.”

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/534784/Remanufacture_SUD_guidance.pdf

By |2019-09-12T16:47:52+00:00June 1st, 2016|Global Regulatory Resource|0 Comments