Regulations
a product. It does not necessarily require the physical handover of a product.6 This is, incidentally, identical to the definition
provided in the EU “Blue Guide” on which the EU Medical Devices Directive is derived, which in turn is from where the UK Medical Device Regulation was originally derived.7
This is why
the MHRA states that a “transfer of ownership” is required.
On the basis of the above, it would appear
that even the MHRA is mistaken! In order for a procedure pack to be placed on the market, it would require the construction of a new procedure pack and the transfer of ownership (not “or”). Let us clarify these two concepts further:
l Criteria 1: Constructing a New Procedure Pack: This is the assembly, packaging, processing and labelling of devices bearing the CE or UKCA marking together within their intended purpose and within the limits of use specified by their manufacturers. This could include the assembly of the entirely new surgical instrument set, or even just part of it – e.g., replacing an instrument on the set with a new one, or adding single use devices such as swabs or holloware to the set. Even the packaging and sterilisation of a single instrument potentially comes under clause 14 of the UK MDR if the ownership is transferred as per criteria 2.
l Criteria 2: Transfer of Ownership: A transfer refers to a sale, loan, hire, lease, gift, or any other type of legal transfer, as clarified in the
GOV.UK guidance. There is no time limit between the procedure pack being constructed and it being placed on the market. For example, an existing procedure pack that has been in circulation within one hospital Trust for some time may be transferred to another hospital Trust, either temporarily (in the case of a Consultant going to another Trust to perform surgery and wanting to use their own instrument sets from their normal Trust) or permanently (in the case of one hospital Trust merging with another).
So, what is the upshot of this? SSDs that are certified and registered to UK MDR that don’t need to be: There are likely to be many of these if they are going by the incorrect understanding of UK MDR applicability outlined
Question
1 Does your organisation reprocess surgical instruments on behalf of another organisation (external customer)? If “no”, proceed to question 6
2 Do you construct new surgical instrument sets for your external customers? 3 Do you replace instruments on your external customers sets? 4 Do you place single-use consumable on your external customers sets?
5 Do you fully refurbish medical devices on behalf of external customers? (i.e., complete rebuilding of a device or the making of a new device from used devices, not simple repairs)
6 Do consultants in your organisation take sets for use in another organisation?
7 Is your organisation in the process of being sold, merged or transferred to another legal entity and ownership of your instrument sets will be transferred in the process?
Table 1.
in the HTMs/WHTMs/SHTMs. If they simply reprocess instruments for another legal entity, but they do not construct new procedure packs for them and transfer ownership of these packs (e.g., if the devices are entirely owned by their external customer at all stages of procedure pack “construction”), then they do not require UK approved body certification or to register with the MHRA. They are likely wasting resources by pursuing this route, as UK MDR certification is typically much more expensive than ISO13485 certification on its own.
SSDs that aren’t certified and registered to UK MDR but should be: There are also quite likely to be many of these if they are going by the incorrect understanding of UK MDR applicability to simply reprocessing of external customers instruments and haven’t considered loans or transfers of sets as detailed.
What to do if you are still not sure if UK MDR applies You can of course ask your notified body; however, they are limited in what advice they can give in delicate matters of interpretation, as they are prohibited from offering consultancy. It may be the case that only the slightest of changes to your Service Level Agreements are required to change the applicability of the UK MDR, but they could not suggest this for you and are unlikely to even confirm if it is possible for fear of falling foul of their restrictions on consultancy. It is the MHRA who are empowered by the Medicines and Medical Devices Act 2021 to provide guidance on such matters. If you are unsure of whether UK MDR applies to your
Ultimately, the sterile service industry must have a say in the future direction of the UK Medical Devices Regulation and there needs to be greater clarity.
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www.clinicalservicesjournal.com I May 2024
department or not, you may write to the MHRA at:
devices.regulatory@
mhra.go.uk It is advised that you provide a clear and
concise description of how procedure packs are constructed and transferred between your own organisation and any other legal entities. To aid this, you may like to prepare answers to the questions shown in Table 1. If you answer ‘no’ to all of these questions, then UK MDR probably doesn’t apply to you. If you answer ‘yes’ to any of these questions it is likely UK MDR does apply to you, unless you have only answered yes to question 1. (See Table 1)
The future It has been pointed out by expert investigators at the Health Services Safety Investigations Body (HSSIB) that the two-tiered regulatory framework poses a risk to patient safety.8
The
UK MDR is going through an update process at the moment. However, if the government response to their public consultation is to be taken as a reasonable guide of what the new UK MDR will look like, the key definitions of “placing on the market” and similar terms do not look like they’re planned for any change that would affect the existence of this two-tiered system.9 The new UK MDR will, however, incorporate
major changes to the requirements for “in- house” manufacture of medical devices, that will essentially bring all SSDs under MHRA supervision. The requirements placed upon SSDs will vary depending on which route to UK MDR is applicable to your healthcare institution: in- house manufacture or placing on the market. It is therefore important that SSD management familiarise themselves with these concepts in order to prepare for the future. These proposed requirements are summarised in Table 2, as per the current intention of the government consultation versus the current UK MDR for applicable SSDs. Readers of this article probably don’t need to be directed to the oddities implied in the
Yes/No
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