Regulations
table. Why should an “in-house” sterile services department “justify why the target patient group’s needs cannot be met with an equivalent device available on the market”? Why should an SSD “placing on the market” require the intervention of a UK approved body, whereas an “in-house” SSD would not? 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.
References 1. Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care Part A: Management and provision, clause 4.15 (p.14), July 2016
2. WHTM 01-01 Welsh Health Technical Memorandum, Decontamination of medical devices within acute services, Part A: Management and environment, clause 2.12 (p.11), 2013
3.
https://www.gov.uk/government/ publications/in-house-manufacture-of- medical-devices/in-house-manufacture-of- medical-devices updated 31 December 2020
4.
https://www.gov.uk/government/publications/ report-a-non-compliant-medical-device- enforcement-process/how-mhra-ensures-the- safety-and-quality-of-medical-devices
5. Statutory Instrument 2002 No. 618, Part I, clause 2 Requirement
Meet the relevant essential requirements of the UK medical devices regulations
Draw up a publicly available declaration of conformity Apply a suitable Quality Management System (QMS)
Justify why the target patient group’s needs cannot be met with an equivalent device available on the market Keep technical information available for the MHRA
Review clinical use of the devices and take necessary corrective actions, for example, stop further use of the device in patients where there is an issue
Report certain types of incidents to the MHRA Register devices with the MHRA
Verified the mutual compatibility of the medical devices in the procedure packs in accordance with the manufacturers’ instructions, and carry out operations in accordance with these instructions
Package the procedure pack and supply relevant information to users incorporating relevant instructions from the manufacturers
The intervention of a UK approved body (limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged)
Table 2. May 2024 I
www.clinicalservicesjournal.com 41
6.
https://www.gov.uk/guidance/placing- manufactured-goods-on-the-market-in-great- britain updated 11 October 2023
7. Official Journal of the European Union C272, Volume 59, Information and Notices, 26 July 2016
8.
https://www.hsib.org.uk/investigations- and-reports/decontamination-of-surgical- instruments/
SSDs “Placing on the Market”
4 4
4
4 4 4
4
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SSDs “In-House Manufacturing”
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4 4 4
4 4
4 About the Author
Jack Walters is the founder and managing director of Sterile Management Systems, an independent quality and regulatory training and consultancy provider to the medical devices and sterile services industries. Jack is a member of both the Education Committee and the Research & Emerging Technologies Committee at the Institute of Decontamination Sciences (IDSc) as well as an IRCA registered principal auditor for quality management systems.
9.
https://www.gov.uk/government/ consultations/consultation-on-the-future- regulation-of-medical-devices-in-the- united-kingdom?utm_medium=email&utm_ campaign=govuk-notifications&utm_ source=66d3e4aa-bb6d-414b-b0f0- 73625877a6ef&utm_content=immediately updated 26 June 2022
CSJ
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