On the 20th July 2015, the Medicines & Healthcare products Regulatory Agency (MHRA), the UK’s National Authority for Medicines and Medical Devices, released a draft guidance on the re-manufacturing of single-use devices (SUDs).
The aim of this guidance document is to set out the UK’s position on the re-manufacturing of SUDs. The draft is now available for review and MHRA, by engaging the medical device professionals in discussion and to gather their views on its new draft guidance, has launched a public survey that is closing on the 1st September 2015.
Although MHRA’s draft only concerns the UK, it may also encourage other EU member states to adopt its position, therefore resulting in more intense discussions at EU level.
Why is MHRA releasing this draft?
There is no current regulation concerning reprocessed SUDs within the EU. As a result, some countries allow the reprocessing of SUDs, while others forbid it and all the rest have no specific regulation regarding it.
The reprocessing of SUDs is not currently allowed in the UK. However, many medical device manufacturers who re-manufacture and mark used SUDs want to place them on the UK market. As such, MHRA has been approached by a number of manufacturers and, for the past two years, has carried out a thorough review of the clinical, regulatory and technical processes performed by SUD re-manufacturers.
This review is reflected in this draft guidance which is aimed at:
- healthcare professionals
- re-manufacturers of SUDs
- any provider of medical devices
Key points of MHRA’s draft guidance
MHRA draws the following conclusions with regard to re-manufacturing SUDs:
- Legal responsibility for re-manufactured SUDs falls to the re-manufacturer. Re-manufacturers are responsible for ensuring compliance with the requirements of the Medical Devices Directive 93/42/EEC and for affixing a CE mark on a device prior to placing it on the market. The device must also successfully undergo an assessment performed by a notified body.
- Class I devices should not be re-manufactured as there would be no external or independent assessment of EU compliance.
- Single-use devices may be re-manufactured for use in the UK. However, the company must meet all relevant compliance criteria and place a CE mark on its product to attest conformity with the legislation.
- A re-manufactured single-use device should only be used once and only on an individual patient.
- The following symbol must be part of the packaging or device and it means single-use/not reusable/use only once:
Additionally, it is important to distinguish the process of re-manufacturing from the process of reprocessing. There is a clear difference between a re-manufactured and reprocessed SUD – its assessment. Reprocessed SUDs after cleaning and sterilization procedures go back on the market bearing their manufacturer´s marking. Also, reprocessed SUDs are not assessed by any certification body, whereas re-manufactured SUDs are assessed by a notified body that confirms its compliance with all the relevant criteria before its placement on the EU market.
What should be expected from this new document?
As new Medical Devices legislation will be introduced in the near future, MHRA believes that this guidance document may need to be updated due to the changes at EU Level concerning the re-manufacturing of SUDs.
According to the current proposal, SUDs may be reprocessed, if permitted by national law. The proposal would consider the reprocessor to be the manufacturer of the medical device with the same compliance responsibilities as the original manufacturer, such as ensuring that the re-processed device is equivalent to the original device in terms of its safety and specification.
If you would like to add something to this ongoing discussion, MHRA is open to your suggestions or comments until the 1st September 2015.
For more information please do not hesitate to contact us.