ISO 13485 (medical devices)

Standards you certify to · awarded by Notified/approved body · serves: Med-device quality consultants

Notices demanding it: 60; a floor
Said “must”: 29; explicit obligation
Open right now: 1
Value gated: £9.1bn; a floor

Published values on the notices that demand it — a floor, not a total.

The demand curve

Notices demanding it per 10,000 published, by year — rate-normalised so corpus growth never masquerades as demand. Complete years only.

1.2

0.2

0.6

0.4

0.6

0.4

1.8

2019202020212022202320242025

The pale bars are 2025 onward. The Procurement Act went live on 24 February 2025 and changed how notices are written, so the step across that date is partly a change in convention and not only a change in demand. We have not measured how much of it is which, so please do not read this as a trend.

The receipts

Notices that demand it, and the sentence each demand was found in. Nothing is counted here without one.

Medical Examination Glovesmandatory
SUPPLY CHAIN COORDINATION LIMITED
Tenderers must hold ISO 9001: 2015, ISO 13485:2016 or Medical Device Single Audit Program (MDSAP) certification, accredited by the United Kingdom Accreditation Service (UKAS) or internationally recognised equivalent.
Supply of Printed Circuit Boards Assembliesmandatory
CENTRE FOR PROCESS INNOVATION LIMITED
For medical device projects, suppliers must adhere to ISO 13485 standards, including strict change control processes to ensure that once supplier and manufacturer part numbers are defined and approved in the Bill of Materials (BoM), they are finalized, signed off, and recorded in the project’s technical file.
Heart Lung Machines Replacementmandatory
Sheffield Teaching Hospitals NHS Foundation Trust
 Fully compliant with all applicable regulations (CE / UKCA marked, compliant with MHRA guidelines, ISO 13485 certification and must meet IEC 60601).
TENDER FOR THE DEVELOPMENT AND SUPPLY OF A SALIVA-BASED LATERAL FLOW IMMUNOASSAYmandatory
THE UNIVERSITY OF BIRMINGHAM
The supplier should be certified to ISO 13485 and able to develop test to be compliant with IVDR 2017/746 requirements.
Quality Management System (MDR Compliance)mandatory
The Common Services Agency (more commonly known as NHS National Services Scotland) ("NSS")
As part of the process to achieve and maintain compliance with the Regulations, a Quality Management System (consistent with ISO 13485) is required.
1313(REISSUE) Development of a new Graphical Interface and Associated Hardware and Software for the Rober NoDec Wizardmandatory
De Montfort University
The evaluation must be undertaken by an ISO 13485 approved (for design and manufacture) organisation and must conform to current Medical Device Directives (MDD) and future Medical Device Requirements (MDR).
Sterile Services Decontamination Equipment - Maintenance, Testing and Validationmandatory
University Hospitals Coventry & Warwickshire NHS
The Sterile Services Department at UHCW is an NHS owned and operated "in-house" surgical instrument reprocessing facility which is accredited to ISO13485:2016 for the decontamination of surgical instruments and other reusable medical devices.
Supply of Biological Indicators (BI) for use in Fumigation Validation of Formaldehyde fumigationsmandatory
MHRA Buyer Organisation
They must be manufactured under ISO 13485.
Regulatory Compliance Services for Medical Devices
NHS England
The procurement covers regulatory compliance services for medical devices, specifically the engagement of a UK Approved Body to conduct a two-stage external audits (Stage 1 and Stage 2) in line with agreed timelines, to urgently achieve ISO 13485 Quality Management System certification.
Medical Devices and Equipment Maintenance and Support service
SIRONA CARE & HEALTH C.I.C.
The provider should comply with quality system standards including European Standard BS EN ISO 13485: (2016) [18] or BS EN ISO 9001:(2015) [19], and compliance with legal frameworks including Lifting Operations and Lifting Equipment Regulations 1998 , The Management of Health and Safety at Work Regulations 1999, Provis…
Heart Attack Diagnosis Software Development
University Of Edinburgh
Operate a quality management system in line with ISO13485 and follow any and all relevant guidance set by medical regulatory bodies in the UK, EU and USA in relation to production of software classed as a ‘medical device’
Re-certification for ISO and Surveillance 1 for UK MDR
Mersey and West Lancashire Teaching Hospital NHS Trust
Annual fees for ISO 13485:2016 and UK MDR Certificate

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1 open tender demand ISO 13485 (medical devices) right now.

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Method: Every count here is a floor. We match the text of the notice, and a notice description is a summary — most tender packs demand things it never mentions.“Said must” counts only explicit obligation language in the matched sentence itself; anything ambiguous is counted as a mention, never as mandatory. Trend compares rates per 10,000 notices per complete calendar year.