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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?

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:

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Upcoming Events

BAUN Summer Educational Event – Essential Urology Skills

Crowne Plaza, Newcastle Stephenson Quarter
6th June 2024

The AfPP Roadshow - Exeter

University of Exeter
22nd June 2024

EBME Expo

Coventry Building Society Arena
26th - 27th June 2024

The AfPP Roadshow - Cardiff

TBA, Cardiff
13th July 2024

AfPP Annual Conference 2024

University of Warwick
2nd - 3rd August 2024

The AfPP Roadshow - London

Cavendish Conference Centre, London
14th September 2024

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

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