Regulations
UK MDR or not UK MDR? The question for SSDs
What do sterile services departments need to know about the UK Medical Devices Regulations? Jack Walters provides an insight into the ‘UK MDR for Healthcare Organisations’ and discusses how this applies to the reprocessing of surgical instruments.
Statutory Instrument 2002 No. 618 “The Medical Devices Regulations 2002” has something of a murky applicability to Sterile Service Departments (SSDs). Clearly reprocessable medical devices purchased by healthcare organisations need to be compliant with these regulations. However, what about the surgical instrument sets that are put together? Is the SSD “manufacturing” a procedure pack? If so, how and when are they “placed on the market”? In addition, how does this relate to what kind of controls, including third party certification and registration, the SSD needs?
The myth You would be forgiven for thinking that healthcare organisations offering the decontamination of reusable medical devices to another legal entity are subject to the requirements of the UK MDR. Perhaps this is something you were told at some point by your auditor or perhaps you read it in your
“Health Technical Memorandum”.1,2 However,
did you know this is in direct contradiction with guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA)?
The MHRA states that: “Sterilisation of devices such as surgical instruments is…not covered by the regulations as long as there is no change of ownership or new procedure pack needed”.3 This suggests that transfer of instruments
from one legal entity to another solely for the purposes of reprocessing does not automatically mean that UK MDR applies. One of two additional criteria must be met – the creation of a new procedure pack or change of ownership.
Who is right? Let us leave aside the fact that HTM 01-01, WHTM 01-01 and SHTM 01-01 are overdue for an update in a post-Brexit regulatory framework anyway; they appear to have over-simplified things
incorrectly in the first place. What is important, however, is that it is not the Department of Health, or their equivalents in Wales & Scotland, that are responsible for enforcement of UK MDR, but the MHRA.4
What do the regulations themselves say? There are a few key concepts that need to be explained here: “Placing on the market” means, in relation to a medical device, the first making available in return for payment or free of charge of a new or fully refurbished device, other than a device intended for clinical investigation, with a view to distribution, use, or both, on the GB market.5 This is a bit of a mouthful, but the key
takeaway here is “first making available”, i.e., a medical device can only be placed on the market once. This is why the MHRA makes a distinction of the creation of a new procedure pack. Once a new procedure pack has been placed on the market, it can’t be placed on the market again, no matter how many times it is exchanged between one organisation and another after this first ‘making available’. So, where are the MHRA getting this concept
of “transfer of ownership”? It is not explicit in the definition of “placing on the market” outlined above, as “making available” isn’t further defined in the UK MDR. For such a clarification, the most pertinent source appears to be from the Department of Business and Trade which states on the
GOV.UK website that: A product is placed on the market when it is first made available for distribution, consumption or use on the GB market as part of a commercial activity. This can be in return for payment or free of charge. This happens after a product has been fully manufactured. A product is placed on the market when an offer or agreement is made for the transfer of ownership, possession or any other property right. Placing on the market can take place before the physical transfer of
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