With the final draft text of the MDR still drying, countries start moving ahead to prepare for the implementation phase. In contrast to the slow speed at which Brexit discussions continue, the UK MHRA decided to speed up its interpretation towards the reprocessing of single use devices.
The new publication focusses on the so-called ‘re-manufacturing’ of single use devices. Playing with words to clarify that this is a different approach than reprocessing of single use devices. It rather is described as building and marketing new devices that have been produced using devices and components that (partially) have been used before. As such the re-manufacturer is seen as a legal manufacturer, who designs and produces new medical devices, brings them on the market under his own name, with his own CE certificate.
This effectively means that, although MHRA does not allow the commercialization of reprocessed single use devices, manufacturers may reprocess single use devices and market them in UK if they follow the re-manufacturing guidance. The system will be organized in such a way that there is control on the number of times a devices is being re-manufactured. Also they will fall under the regular vigilance systems that are in place for CE marked medical devices. Class I products do not fall under the new rules, as there would be no notified bodies involved, so it would not result in additional supervision.
The MHRA guidance appears to be compliant with the requirements of the new EU Medical Device Regulation. In a later stage under the MDR, the current guidance will need to be embedded in the national law, assuming at that stage UK will be following the MDR requirements. As such, one could see the guidance as an attempt to test the system prior to writing a supporting national law on it.
It certainly is an interesting concept to provide control over reprocessing of single use devices, and by setting aside a special name for it, the authorities and responsibilities of parties involved can be much better defined. In a way it is a pity that the ideas behind the guidance were not endorsed as an integral part of the final draft MDR.
It will be interesting to watch which other national guidance will appear in the upcoming months, where authorities write down some of the views and policies that have not made it into the final MDR text. The regulatory affairs life ahead of us in the EU will certainly not be boring.
Read more on the MHRA guidance in a recent Medtech Insight story. (article in pdf )
Dr. Gert W. Bos, Executive Director & Partner at Qserve consultancy
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