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← Gmdn Agency

2025-03-31-accounts

Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

REGISTERED COMPANY NUMBER: 05392271 (England and Wales) REGISTERED CHARITY NUMBER: 1154418

REPORT OF THE TRUSTEES AND

AUDITED FINANCIAL STATEMENTS FOR THE YEAR ENDED 31 MARCH 2025

FOR

GMDN AGENCY

Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY

CONTENTS OF THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 31 MARCH 2025

Page
Report of the Trustees 1 to 7
Report of the Independent Auditors 8 to 11
Statement of Financial Activities 12
Statement of Financial Position 13
Statement of Cash Flows 14
Notes to the Statement of Cash Flows 15
Notes to the Financial Statements 16 to 24

Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY (REGISTERED NUMBER: 05392271)

REPORT OF THE TRUSTEES FOR THE YEAR ENDED 31 MARCH 2025

The trustees who are also directors of the charity for the purposes of the Companies Act 2006, present their report with the financial statements of the charity for the year ended 31 March 2025. The trustees have adopted the provisions of Accounting and Reporting by Charities: Statement of Recommended Practice applicable to charities preparing their accounts in accordance with the Financial Reporting Standard applicable in the UK and Republic of Ireland (FRS 102) (effective 1 January 2019).

OBJECTIVES AND ACTIVITIES

Purposes and aims

Our charity's purposes, as set out in the objects contained in the company's memorandum of association, are to:

To preserve and protect health and to relieve sickness for the public benefit by developing and maintaining the 'Global Medical Device Nomenclature', a system of internationally agreed descriptors used to identify medical device products which will meet a global need for identification purposes. Our aims fully reflect the purposes that the charity was set up to further.

Our charity's purposes, as set out in the objects contained in the company's Articles of Association, are to:

To preserve and protect health and relieve sickness for the public benefit by developing and maintaining the "Global Medical Device Nomenclature", a system of internationally agreed descriptors used to identify medical device products which will meet a global need for identification purposes.

Our Strategic Aims, as identified in our Quality Policy, fully reflect the purposes that the charity was set up to further:

Ensuring our work delivers our aims

We review our Strategic Aims each year (The annual review took place in February 2025). This review looks at what we achieved and the outcomes of our work in the previous 12 months. The review looks at the success of each key activity and the benefits they have brought to those groups of people we are set up to help. The review also helps us ensure that our aims, objectives and activities remain focused on our stated purposes. We have referred to the guidance contained in the Charity Commission's general guidance on public benefit when reviewing our aims and objectives and in planning our future activities. In particular, the trustees consider how planned activities will contribute to the aims and objectives they have set.

The focus of our work

After extensive consultation, the Strategy 2022-2026 was published in early 2022. To deliver the GMDN Agency's core work of helping to meet the global need for accurate identification of medical devices, we have developed four ambitions, the aims for those areas of work and where we expect to be at the end of the five-year strategy period.

Page 1

Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY (REGISTERED NUMBER: 05392271)

REPORT OF THE TRUSTEES FOR THE YEAR ENDED 31 MARCH 2025

OBJECTIVES AND ACTIVITIES

Public benefit

Our main activities and who we try to help are described below. All our charitable activities focus on the accurate identification of medical devices by standardising their common description and sharing this information with Governments, Hospitals and device manufacturers worldwide for the public benefit.

Who used and benefited from our services?

Our objects and funding limit the services we provide to the maintenance, promotion and distribution of the Global Medical Device Nomenclature.

Equal access to our services is an important issue for us. All potential users of the GMDN can gain free access to the GMDN data.

Medical device regulators use the GMDN data to identify specific equipment accurately when they need to approve medical devices as part of their national regulatory framework.

When monitoring the safety of medical devices within the market, medical device regulators can use the GMDN to identify trends in the success and failure of a specific device or common technology, which is vitally important when systematic failures of devices from more than one manufacturer may occur.

Medical device manufacturers use GMDN data to sort their products into more manageable groups and provide more consistent device names to their customers.

Medical device users can use GMDN data to support decision-making within the healthcare environment.

We maintain our database to provide information to our members in 14 languages, thereby encouraging wider global access to the GMDN.

The GMDN Agency continues to maintain its Quality Management System compliance to standard ISO9001:2015 by a third-party audit.

To demonstrate our commitment to information security, the GMDN Agency was re-certified to the UK Government's Cyber Essentials scheme in October 2024.

FINANCIAL REVIEW

Principal funding sources

The principal funding sources for the charity are currently the licencing of services related to the maintenance of the GMDN to our members via our website.

Access is only available to members and membership is priced according to organisation type and size. The membership process is completed online and access to the GMDN database is immediate upon completion of the registration process. Over 91% of organisations access our membership services free of any cost, and some commercial organisations that make up the balance, volunteer to subscribe to our paid membership services.

Investment policy and objectives

Aside from retaining a prudent amount in reserves each year, most of the charity's funds are to be spent in the short term, so there are few funds for long-term investment. With the aid of sound financial management and the support of its staff and volunteers, the charity maintained a total of funds carried forward amounting to £1,185,661.

Page 2

Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY (REGISTERED NUMBER: 05392271)

REPORT OF THE TRUSTEES FOR THE YEAR ENDED 31 MARCH 2025

FINANCIAL REVIEW

Reserves policy

The GMDN Agency, as a charitable activity designed to provide services to members, should operate on the basis of costs equating to income over the long term. Reserves will be held to ensure continuity of operation and provide a buffer for variations in income or respond to short-term expenditure needs not accommodated by the normal running of the organisation, as well as addressing anticipated future change costs associated with both environmental and operational necessities e.g. changes in business model, major recapitalisation of assets, etc.

The charity aims to hold around six months' of expenditure in general reserves in case the database were to go down (including from risk of cyber attack or global server failures) and if the funds exceeded this, they would be used for investing in the database recovery and building new infrastructure. If there was still an excess, funds would be returned to members via adjustments to the fees for the service.

Designated reserves are categorised as Operational and Strategic reserves.

The Operational reserve is to cover cash flow variability and anticipated short-term variations in either income or expenditure. It also needs to cover the cost of winding up the Agency, subject to the possibility that the Agency needs to be closed.

The Strategic reserve is to cover anticipated needs over and above those accommodated by the Operational reserve but required to support the long-term sustainability of the Agency. This needs to be consistent with the conditions applied above.

The level of these reserves is agreed on an annual basis by the Trustees as part of the financial budgeting process.

During the year, the charity received a £5,000 restricted grant. Restricted expenditure of £5,000 was subsequently incurred and there was therefore no restricted fund balance carried forward at 31 March 2025. There was no restricted income or restricted expenditure in the previous year and no restricted fund balance at 31 March 2024.

FUTURE DEVELOPMENTS

The effective use of the GMDN by national medical device regulators and other stakeholders throughout the world continues to be the primary objective of the Agency.

The Trustees deliberately build up the reserves in the past few years to meet the challenges and costs associated with the increasing use of the GMDN. Due to the long-term nature of adopting the GMDN, the timing of the use of funds can be challenging to predict. It is expected that the adoption of the GMDN will require the investment of substantial funds in supporting adoption and supporting users worldwide.

Our larger company members have remained loyal to the voluntary paid-for services we provide to support their management of the GMDN Terms they use and therefore our income has remained enough to allow the Trustees to be confident of our long-term financial sustainability. The membership schemes will be carefully monitored during the coming years to determine their ongoing suitability of purpose and amended as necessary.

With the increased global recognition and use of GMDN, several countries and NGOs have joined in adopting the use of the GMDN, and this is particularly important in countries with less-developed economies.

STRUCTURE, GOVERNANCE AND MANAGEMENT

Governing document

The organisation is a charitable company limited by guarantee, incorporated on 14 March 2005 and registered as a charity on 31 October 2013. The company was established under a Memorandum of Association which established the objects and powers of the charitable company and is governed under its Articles of Association. In the event of the company being wound up members are required to contribute an amount not exceeding £10.

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

REPORT OF THE TRUSTEES FOR THE YEAR ENDED 31 MARCH 2025

GMDN AGENCY (REGISTERED NUMBER: 05392271)

STRUCTURE, GOVERNANCE AND MANAGEMENT

Recruitment and appointment of new trustees

The directors of the company are also charity trustees for the purposes of charity law and under the company's Articles are known as members of the Board of Trustees. Under the requirements of the Memorandum and Articles of Association the members of the Board of Trustees are elected to serve for a period of three years after which they must be re-elected at the next Annual General Meeting.

All members of the Board of Trustees give their time voluntarily and received no benefits from the charity. Any expenses reclaimed from the charity are set out in note 8 to the accounts.

Due to the nature of the medical device sector much of the charity's work inevitably focuses upon this subject. The Board of Trustees seeks to ensure that the needs of this sector are appropriately reflected through the members of the trustee body.

To enhance the potential pool of trustees, the charity, through selective networking with industry, regulators and healthcare providers, has sought to identify those individuals who would be willing to become members of the Agencies advisory committees and use their own experience to assist the charity.

In early 2022 following the launch of our new strategy, we established the Authorities Strategic Advisory Group (ASAG) as a standing advisory committee to the Board of Trustees. This committee strengthens the voice of regulators in the strategic planning of the Agency and has been very useful, with regulators from Australia, Brazil, Canada, the UK and the USA now actively participating. The Advisory Committee and the Board of Trustees meet three times a year.

The more traditional business and medical skills are well represented on the Board of Trustees. In an effort to maintain this broad skill mix, members of the Board of Trustees are requested to provide a list of their skills and in the event of particular skills being lost due to retirements, individuals are approached to offer themselves for election to the Board of Trustees. Two new Trustees joined the Board within the last year.

The Trustees as part of the recent strategic planning process, wish to increase the active involvement of regulators in our governance and therefore are engaging with them to see how this can be done in the coming year.

Organisational structure

The Board of Trustees consists of up to eight members who meet quarterly and are responsible for the charity's strategic direction and policy. At present, the Committee has eight members from a variety of professional backgrounds relevant to the charity's work.

A scheme of delegation is in place and day to day responsibility for the provision of the services rests with the Chief Executive Officer. The Chief Executive Officer is responsible for ensuring that the charity delivers the services specified and that key performance indicators are met. The Senior Clinical Lead and Term Development Team has overall responsibility for the maintenance of the Global Medical Device Nomenclature database, and the Office Administrators have responsibility for the customer services staff. The Chief Executive Officer has individual supervision of all staff and also ensures that the team continue to develop their skills in line with good working practice.

CEO, Deniz Bruce, was appointed in November 2022 and is now driving the Agency forward in its delivery of our strategic and operational plan. Focusing on expanding the use of the GMDN Database (currently used in around 140 countries) beyond the regulatory pre- and post-market use, building new partnerships and supporting global harmonisation for device naming and grouping of medical devices, as well as the business sustainability plans.

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY (REGISTERED NUMBER: 05392271)

REPORT OF THE TRUSTEES FOR THE YEAR ENDED 31 MARCH 2025

STRUCTURE, GOVERNANCE AND MANAGEMENT

Induction and training of new trustees

Trustees are already familiar with the practical work of the charity, having been encouraged to have been a previous members of Agencies advisory committees.

Additionally, new trustees are invited and encouraged to attend a training session to familiarise themselves with the charity and the context within which it operates. This is led by the Chief Executive Officer of the charity and covers:

A resource pack has been prepared drawing information from the various Charity Commission publications. This is distributed to all new trustees along with the Articles of Association, Governance, Policy and reference documents and the latest management financial report.

Charity representation

In so far as it is complimentary to the charity's objects, the charity is guided by international forum for medical device safety, including the members of the International Medical Device Regulators Forum (IMDRF) and the Global Harmonisation Working Party (GHWP) as well as international medical device manufacturers' trade associations, including the Global Medical Technology Alliance (GMTA) and the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA). The representation of the GMDN Agency to these organisations has proved invaluable to the charity in establishing improved links with the medical device sector and identifying relevant policy improvements.

Risk management

The Board of Trustees has conducted a review of the major risks to which the charity is exposed. Our risk register is reviewed at every Board meeting. Where appropriate, systems or procedures have been established to mitigate the risks the charity faces. Significant external risks to funding have led to the development of a strategic plan which will allow for the planning of funding and activities. Internal control risks are minimised by the implementation of procedures for authorisation of all transactions and projects. Procedures are in place to ensure compliance with health and safety of staff, volunteers, clients and visitors to the GMDN Agency's offices. The third-party certification of our ISO 9001 Quality Management System supports a consistent quality of delivery for all operational aspects of the charity. All internal procedures are regularly audited to ensure that they continue to meet the needs of the charity.

REFERENCE AND ADMINISTRATIVE DETAILS Registered Company number

05392271 (England and Wales)

Registered Charity number

1154418

Registered office

Hampden House Monument Business Park Chalgrove Oxford Oxfordshire OX44 7RW

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY (REGISTERED NUMBER: 05392271)

REPORT OF THE TRUSTEES FOR THE YEAR ENDED 31 MARCH 2025

Trustees

Dr E D Krell (resigned 4/9/2025) Ms J Trunzo Dr C M W Tong Mr J Wilkinson Mrs D Bruce Mr D Black Mr A Kwek (appointed 5/12/2024) Ms J Goulding (appointed 13/6/2024)

Company Secretary

Mrs D Bruce

Auditors

MGI Midgley Snelling LLP Ibex House Baker Street Weybridge Surrey KT13 8AH

Solicitors

Mishcon de Reya LLP Buxton Court Minns Business Park, Unit 3 West Way Botley Oxford OX2 0JB

STATEMENT OF TRUSTEES' RESPONSIBILITIES

The trustees (who are also the directors of GMDN Agency for the purposes of company law) are responsible for preparing the Report of the Trustees and the financial statements in accordance with applicable law and United Kingdom Accounting Standards (United Kingdom Generally Accepted Accounting Practice) including Financial Reporting Standard 102 "The Financial Reporting Standard applicable in the UK and Republic of Ireland".

Company law requires the trustees to prepare financial statements for each financial year. Under that law, the trustees have elected to prepare the financial statements in accordance with United Kingdom Generally Accepted Accounting Practice (United Kingdom Accounting Standards and applicable law).

Under company law the trustees must not approve the financial statements unless they are satisfied that they give a true and fair view of the state of affairs of the charitable company and of the incoming resources and application of resources, including the income and expenditure, of the charitable company for that period. In preparing those financial statements, the trustees are required to

The trustees are responsible for keeping proper accounting records which disclose with reasonable accuracy at any time the financial position of the charitable company and to enable them to ensure that the financial statements comply with the Companies Act 2006. They are also responsible for safeguarding the assets of the charitable company and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities.

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY (REGISTERED NUMBER: 05392271)

REPORT OF THE TRUSTEES FOR THE YEAR ENDED 31 MARCH 2025

STATEMENT OF TRUSTEES' RESPONSIBILITIES - continued

In so far as the trustees are aware:

AUDITORS

MGI Midgley Snelling LLP were appointed as the charitable company's auditors during the year and have expressed their willingness to continue in that capacity.

16 October 2025

Approved by order of the board of Trustees on ............................................. and signed on its behalf by:

................................................................. Mrs D Bruce - Trustee

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

REPORT OF THE INDEPENDENT AUDITORS TO THE MEMBERS OF GMDN AGENCY

Opinion

We have audited the financial statements of GMDN Agency (the 'charitable company') for the year ended 31 March 2025 which comprise the Statement of Financial Activities, the Statement of Financial Position, the Statement of Cash Flows and notes to the financial statements, including a summary of significant accounting policies. The financial reporting framework that has been applied in their preparation is applicable law and United Kingdom Accounting Standards (United Kingdom Generally Accepted Accounting Practice), including Financial Reporting Standard 102 'The Financial Reporting Standard applicable in the UK and Republic of Ireland'.

Basis for opinion

We conducted our audit in accordance with International Standards on Auditing (UK) (ISAs (UK)) and applicable law. Our responsibilities under those standards are further described in the Auditors' responsibilities for the audit of the financial statements section of our report. We are independent of the charitable company in accordance with the ethical requirements that are relevant to our audit of the financial statements in the UK, including the FRC's Ethical Standard, and we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.

Conclusions relating to going concern

In auditing the financial statements, we have concluded that the trustees' use of the going concern basis of accounting in the preparation of the financial statements is appropriate.

Based on the work we have performed, we have not identified any material uncertainties relating to events or conditions that, individually or collectively, may cast significant doubt on the charitable company's ability to continue as a going concern for a period of at least twelve months from when the financial statements are authorised for issue.

Our responsibilities and the responsibilities of the trustees with respect to going concern are described in the relevant sections of this report.

Other information

The trustees are responsible for the other information. The other information comprises the information included in the Annual Report, other than the financial statements and our Report of the Independent Auditors thereon.

Our opinion on the financial statements does not cover the other information and, except to the extent otherwise explicitly stated in our report, we do not express any form of assurance conclusion thereon.

In connection with our audit of the financial statements, our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the audit or otherwise appears to be materially misstated. If we identify such material inconsistencies or apparent material misstatements, we are required to determine whether this gives rise to a material misstatement in the financial statements themselves. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard.

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

REPORT OF THE INDEPENDENT AUDITORS TO THE MEMBERS OF GMDN AGENCY

Opinions on other matters prescribed by the Companies Act 2006

In our opinion, based on the work undertaken in the course of the audit:

Matters on which we are required to report by exception

In the light of the knowledge and understanding of the charitable company and its environment obtained in the course of the audit, we have not identified material misstatements in the Report of the Trustees.

We have nothing to report in respect of the following matters where the Companies Act 2006 requires us to report to you if, in our opinion:

Responsibilities of trustees

As explained more fully in the Statement of Trustees' Responsibilities, the trustees (who are also the directors of the charitable company for the purposes of company law) are responsible for the preparation of the financial statements and for being satisfied that they give a true and fair view, and for such internal control as the trustees determine is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.

In preparing the financial statements, the trustees are responsible for assessing the charitable company's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the trustees either intend to liquidate the charitable company or to cease operations, or have no realistic alternative but to do so.

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

REPORT OF THE INDEPENDENT AUDITORS TO THE MEMBERS OF GMDN AGENCY

Our responsibilities for the audit of the financial statements

Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue a Report of the Independent Auditors that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs (UK) will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements.

The extent to which our procedures are capable of detecting irregularities, including fraud is detailed below:

Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design procedures in line with our responsibilities, outlined above, to detect material misstatements in respect of irregularities, including fraud. The extent to which our procedures are capable of detecting irregularities, including fraud, is detailed below.

In planning and designing our audit tests, we identify and assess the risks of material misstatements within the financial statements, whether due to fraud or error. Our assessment of these risks includes consideration of the nature of the industry and sector, the control environment and the business performance along with the results of our enquiries of management, about their own identification and assessment of the risks of irregularities. We are also required to perform specific procedures to respond to the risk of management override.

As a result of this assessment, we considered the opportunities and incentives that may exist within the company for fraud and identified that the greatest area of risk was in relation to management override and valuation of intangible assets.

We have obtained an understanding of the legal and regulatory frameworks that the company operates in from discussions with the directors and our knowledge of the company and its industry sector. We have focussed on the provisions of those laws and regulations that have a direct effect on the determination of material amounts and disclosures in the financial statements. The key laws and regulations we considered in this context included the UK Companies Act and local tax legislation.

We performed the following audit procedures after consideration of the above risks which included the following:

The engagement partner has assessed that all engagement team members were made aware of the relevant laws and regulations and potential fraud risks and were reminded to remain alert to any indications of fraud or non-compliance with laws and regulations throughout the audit.

Because of the inherent limitations of an audit, there is a risk that we will not detect all irregularities, including those leading to a material misstatement in the financial statements or non-compliance with regulation. The risk increases the more that compliance with a law or regulation is removed from the events and transactions reflected in the financial statements, as we will be less likely to become aware of instances of non-compliance. The risk is also greater regarding irregularities occurring due to fraud rather than error, as fraud involves intentional concealment, forgery, collusion, omission or misrepresentation.

A further description of our responsibilities is available on the Financial Reporting Council's website at: https://www.frc.org.uk/auditorsresponsibilities. This description forms part of our auditor's report.

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

REPORT OF THE INDEPENDENT AUDITORS TO THE MEMBERS OF GMDN AGENCY

Use of our report

This report is made solely to the charitable company's members, as a body, in accordance with Chapter 3 of Part 16 of the Companies Act 2006. Our audit work has been undertaken so that we might state to the charitable company's members those matters we are required to state to them in an auditors' report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the charitable company and the charitable company's members as a body, for our audit work, for this report, or for the opinions we have formed.

Sarah Squires BEng FCA (Senior Statutory Auditor) for and on behalf of MGI Midgley Snelling LLP Ibex House Baker Street Weybridge Surrey KT13 8AH 16 October 2025 Date: .............................................

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY

STATEMENT OF FINANCIAL ACTIVITIES (INCORPORATING AN INCOME AND EXPENDITURE ACCOUNT) FOR THE YEAR ENDED 31 MARCH 2025

Notes
INCOME AND ENDOWMENTS FROM
Donations and legacies
3
Investment income
4
Total
EXPENDITURE ON
Charitable activities
5
Development and maintenance of database
NET INCOME/(EXPENDITURE)
RECONCILIATION OF FUNDS
Total funds brought forward
TOTAL FUNDS CARRIED FORWARD		 Unrestricted
funds
£
1,876,034
18,627
1,894,661
1,291,883
602,778
582,883
1,185,661		 Restricted
fund
£
5,000
-
5,000
5,000
-
-
-		 2025
Total
funds
£
1,881,034
18,627
1,899,661
1,296,883
602,778
582,883
1,185,661		 2024
Total
funds
£
1,260,956
8,704
1,269,660
1,638,076
(368,416)
951,299
582,883

The notes form part of these financial statements

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY (REGISTERED NUMBER: 05392271)

STATEMENT OF FINANCIAL POSITION 31 MARCH 2025

2025 2024
Unrestricted Restricted Total Total
funds fund funds funds
Notes £ £ £ £
FIXED ASSETS
Intangible assets 10 394,361 - 394,361 306,344
Tangible assets 11 7,702 - 7,702 10,014
402,063 - 402,063 316,358
CURRENT ASSETS
Debtors 12 63,047 - 63,047 54,615
Cash at bank 1,799,322 - 1,799,322 1,049,370
1,862,369 - 1,862,369 1,103,985
CREDITORS
Amounts falling due within one year 13 (1,078,771) - (1,078,771) (837,460)
NET CURRENT ASSETS 783,598 - 783,598 266,525
TOTAL ASSETS LESS CURRENT
LIABILITIES 1,185,661 - 1,185,661 582,883
NET ASSETS 1,185,661 - 1,185,661 582,883
FUNDS 14
Unrestricted funds 1,185,661 582,883
TOTAL FUNDS 1,185,661 582,883

These financial statements have been prepared in accordance with the provisions applicable to charitable companies subject to the small companies regime.

The financial statements were approved by the Board of Trustees and authorised for issue on ............................................. and were signed on its behalf by: 16 October 2025

............................................. Mrs D Bruce - Trustee

The notes form part of these financial statements

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY

STATEMENT OF CASH FLOWS FOR THE YEAR ENDED 31 MARCH 2025

Notes
Cash flows from operating activities
Cash generated from operations
1
Net cash provided by operating activities
Cash flows from investing activities
Purchase of intangible fixed assets
Purchase of tangible fixed assets
Interest received
Net cash used in investing activities
Change in cash and cash equivalents
in the reporting period
Cash and cash equivalents at the
beginning of the reporting period
Cash and cash equivalents at the end
of the reporting period		 2025
£
994,460
994,460
(258,277)
(4,858)
18,627
(244,508)
749,952
1,049,370
1,799,322		 2024
£
55,292
55,292
(149,571)
(5,082)
8,704
(145,949)
(90,657)
1,140,027
1,049,370

The notes form part of these financial statements

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY

NOTES TO THE STATEMENT OF CASH FLOWS FOR THE YEAR ENDED 31 MARCH 2025

1. RECONCILIATION OF NET INCOME/(EXPENDITURE) TO NET CASH FLOW FROM OPERATING ACTIVITIES

ACTIVITIES
Net income/(expenditure) for the reporting period (as per the
Statement of Financial Activities)
Adjustments for:
Depreciation charges
Interest received
Increase in debtors
Increase in creditors
Net cash provided by operations		 2025
£
602,778
177,430
(18,627)
(8,432)
241,311
994,460		 2024
£
(368,416)
158,698
(8,704)
(13,455)
287,169
55,292

2. ANALYSIS OF CHANGES IN NET FUNDS

Net cash
Cash at bank
Total		 At 1.4.24
£
1,049,370
1,049,370
1,049,370		 Cash flow
£
749,952
749,952
749,952		 At 31.3.25
£
1,799,322
1,799,322
1,799,322

The notes form part of these financial statements

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 31 MARCH 2025

GMDN AGENCY

1. GENERAL INFORMATION

GMDN Agency is a charitable company limited by guarantee and incorporated in England and Wales. The address of the company's registered office is Hampden House, Monument Business Park, Chalgrove, Oxford, OX44 7RW. The registered company number is 05392271 and the registered charity number is 1154418.

The principal activities of the charity are as disclosed within the Report of the Trustees.

The presentational currency of these financial statements is Sterling (£), being the currency of the primary economic market in which the entity operates. All amounts in these financial statements have been rounded to the nearest pound unless stated otherwise.

The significant accounting policies applied in the preparation of these financial statements are set out below. These policies have been consistently applied to all years presented unless otherwise stated.

2. ACCOUNTING POLICIES

Basis of preparing the financial statements

The financial statements of the charitable company, which is a public benefit entity under FRS 102, have been prepared in accordance with the Charities SORP (FRS 102) 'Accounting and Reporting by Charities: Statement of Recommended Practice applicable to charities preparing their accounts in accordance with the Financial Reporting Standard applicable in the UK and Republic of Ireland (FRS 102) (effective 1 January 2019)', Financial Reporting Standard 102 'The Financial Reporting Standard applicable in the UK and Republic of Ireland' and the Companies Act 2006. The financial statements have been prepared under the historical cost convention.

Going Concern

The trustees have considered the substantial net assets of the charity and the cash resources available as well as the charity's commitments. The trustees consider that the charity has adequate resources in place to continue in operation for a period of at least twelve months from the date of approval of the financial statements and therefore continue to adopt the going concern basis in preparing these financial statements.

Income

All income is recognised in the Statement of Financial Activities once the charity has entitlement to the funds, it is probable that the income will be received and the amount can be measured reliably. Membership fees are recognised equally over the period of the 12 month subscription.

Expenditure

Liabilities are recognised as expenditure as soon as there is a legal or constructive obligation committing the charity to that expenditure, it is probable that a transfer of economic benefits will be required in settlement and the amount of the obligation can be measured reliably. Expenditure is accounted for on an accruals basis and has been classified under headings that aggregate all costs related to the category.

Allocation and apportionment of costs

Where costs cannot be directly attributed to particular headings they have been allocated to activities on a basis consistent with use of the resources.

Trustee salaries have been apportioned in accordance with the duties to which they relate.

Intellectual property

The cost of developing the company's database and associated systems is being capitalised and amortised through the Statement of Financial Activities in equal annual instalments over its estimated economic life of 5 years. The cost of development includes staff costs.

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NOTES TO THE FINANCIAL STATEMENTS - continued FOR THE YEAR ENDED 31 MARCH 2025

GMDN AGENCY

2. ACCOUNTING POLICIES - continued

Tangible fixed assets

Depreciation is provided at the following annual rates in order to write off each asset over its estimated useful life.

Computers and furniture

Taxation

The charity is exempt from corporation tax on its charitable activities.

Fund accounting

Unrestricted funds can be used in accordance with the charitable objectives at the discretion of the trustees.

Restricted funds can only be used for particular restricted purposes within the objects of the charity. Restrictions arise when specified by the donor or when funds are raised for particular restricted purposes.

All the charity's funds are unrestricted as at 31 March 2025.

Foreign currencies

Transactions in foreign currencies are recorded at the rate ruling at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies are translated at the rate of exchange ruling at the balance sheet date. All differences are taken to the Statement of Financial Activities.

Hire purchase and leasing commitments

Rentals paid under operating leases are charged to the Statement of Financial Activities on a straight line basis over the period of the lease.

Pension costs and other post-retirement benefits

The charitable company operates a defined contribution pension scheme. Contributions payable to the charitable company's pension scheme are charged to the Statement of Financial Activities in the period to which they relate.

Financial instruments

The charitable company only has financial assets and financial liabilities of a kind that qualify as basic financial instruments. Basic financial instruments are initially recognised at transaction value and subsequently measured at their settlement value.

Significant judgements and estimates

The preparation of the financial statements requires management to make estimates and assumptions that affect the reported amounts of income, expenditure, assets and liabilities. If in the future such estimates and assumptions, which are based on management's best judgment at the date of the financial statements, deviate from the actual circumstances, the original estimates and assumptions will be modified as appropriate in the year in which the circumstances change.

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NOTES TO THE FINANCIAL STATEMENTS - continued FOR THE YEAR ENDED 31 MARCH 2025

3. DONATIONS AND LEGACIES

Donations
Grants
Subscriptions
Grants received, included in the above, are as follows:
Other grants
Further details of the grant received are disclosed in note 14.
4.
INVESTMENT INCOME
Bank interest
5.
CHARITABLE ACTIVITIES COSTS
Direct
Costs
£
Development and maintenance of
database
1,157,444
6.
SUPPORT COSTS
Management
Finance
£
£
Development and maintenance of
database
100,983
30,316		 2025
£
-
5,000
1,876,034
1,881,034
2025
£
5,000
2025
£
18,627
Support
costs (see
note 6)
£
139,439
Governance
costs
£
8,140		 2024
£
19
-
1,260,937		 2024
£
19
-
1,260,937		 2024
£
19
-
1,260,937
1,260,956
2024
£
-
2024
£
8,704
Totals
£
1,296,883		 2024
£
-
2024
£
8,704
Totals
£
139,439

Analysis of support and governance costs

The charity initially identifies the costs of its support function. It then identifies those costs which relate to the governance function. Having identified its governance costs and support costs these are apportioned between the key charitable activities undertaken in the year. Please refer to the table below for the basis of apportionment and the key analysis of support.

General
Governance
Support
function
Basis of apportionment		 General
Governance
Support
function
Basis of apportionment		 General
Governance
Support
function
Basis of apportionment
£ £
Wages
100,983		 The duties to which they relate
Audit fees 8,140
Governance
Accountancy 30,316 The duties to which they relate
Total
131,299		 8,140

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NOTES TO THE FINANCIAL STATEMENTS - continued FOR THE YEAR ENDED 31 MARCH 2025

7. NET INCOME/(EXPENDITURE)

Net income/(expenditure) is stated after charging/(crediting):

8.

Auditors' remuneration
Depreciation - owned assets
Other operating leases
Intellectual property amortisation
Foreign exchange (gains)/losses
TRUSTEES' REMUNERATION AND BENEFITS
Trustees' salaries
Trustees' social security
Trustees' pension contributions to money purchase schemes		 2025
£
8,140
7,170
7,861
170,260
10,827
2025
£
176,361
17,988
8,752
203,101		 2024
£
7,595
6,728
24,719
151,970
18,045
2024
£
172,334
21,194
8,498
202,026

The trustees’ remuneration relates to one trustee (2024: one), Mrs D Bruce, for services rendered as Chief Executive Officer of the charity.

Trustees' expenses

Trustees' expenses reimbursed for the year ended 31 March 2025 totalled £28,683 to five trustees (2024 - £16,586 to four trustees), of which £nil (2024: £2,451) was due at the year end. Expenses related to travel and conferences.

9. STAFF COSTS

Wages and salaries
Social security costs
Other pension costs		 2025
£
691,881
72,649
33,783
798,313		 2024
£
731,737
84,203
36,355
852,295

During the year £211,970 (2024 - £121,652) of salaries and pension as well as £21,499 (2024 - £13,169) of social security costs were capitalised as part of the intangible fixed asset. These costs are not included in the figures above.

The average monthly number of employees during the year was as follows:

Management
Technical
Administration		 2025
1
7
5
13		 2024
1
7
4
12

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NOTES TO THE FINANCIAL STATEMENTS - continued FOR THE YEAR ENDED 31 MARCH 2025

9. STAFF COSTS - continued

The number of employees whose employee benefits (excluding employer pension costs) exceeded £60,000 was:

£60,001 - £70,000
£70,001 - £80,000
£80,001 - £90,000
£90,001 - £100,000
£110,001 - £120,000
£130,001 - £140,000
£170,001 - £180,000
INTANGIBLE FIXED ASSETS
COST
At 1 April 2024
Additions
At 31 March 2025
AMORTISATION
At 1 April 2024
Charge for year
At 31 March 2025
NET BOOK VALUE
At 31 March 2025
At 31 March 2024		 2025
2
1
-
1
1
-
1
6		 2024
2
1
1
-
-
1
1
6
Intellectual
property
£
1,723,315
258,277
1,981,592
1,416,971
170,260
1,587,231
394,361
306,344

10. INTANGIBLE FIXED ASSETS

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NOTES TO THE FINANCIAL STATEMENTS - continued FOR THE YEAR ENDED 31 MARCH 2025

11. TANGIBLE FIXED ASSETS

COST
At 1 April 2024
Additions
Disposals
At 31 March 2025
DEPRECIATION
At 1 April 2024
Charge for year
Eliminated on disposal
At 31 March 2025
NET BOOK VALUE
At 31 March 2025
At 31 March 2024
12.
DEBTORS: AMOUNTS FALLING DUE WITHIN ONE YEAR
2025
£
Trade debtors
31,304
Other debtors
25
Prepayments and accrued income
31,718
63,047
13.
CREDITORS: AMOUNTS FALLING DUE WITHIN ONE YEAR
2025
£
Trade creditors
16,709
Social security and other taxes
27,634
Other creditors
9,645
Accruals and deferred income
1,024,783
1,078,771
Included within accruals and deferred income is the following deferred income:
Deferred income at 31 March 2024
Released in the year
Deferred in the year
Deferred income at 31 March 2025		 Computers
and
furniture
£
44,884
4,858
(4,004)
45,738
34,870
7,170
(4,004)
38,036
7,702
10,014
2024
£
31,198
3,423
19,994
54,615
2024
£
9,369
28,075
7,114
792,902
837,460
£
770,539
(770,539)
1,000,661
1,000,661

The deferred income is in respect of the annual memberships to the database.

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NOTES TO THE FINANCIAL STATEMENTS - continued FOR THE YEAR ENDED 31 MARCH 2025

14. MOVEMENT IN FUNDS

At 1.4.24
£
Unrestricted funds
General fund
2,633
Designated cash flow fund
250,000
Designated reserve fund
330,250
582,883
TOTAL FUNDS
582,883
Net movement in funds, included in the above are as follows:
Incoming
resources
£
Unrestricted funds
General fund
1,894,661
Restricted funds
Innovate UK fund
5,000
TOTAL FUNDS
1,899,661
Comparatives for movement in funds
Net
movement
At 1.4.23
in funds
£
£
Unrestricted funds
General fund
171,049
(368,416)
Designated cash flow fund
250,000
-
Designated reserve fund
530,250
-
951,299
(368,416)
TOTAL FUNDS
951,299
(368,416)		 Net
movement
in funds
£
602,778
-
-
602,778
602,778
Resources
expended
£
(1,291,883)
(5,000)
(1,296,883)
Transfers
between
funds
£
200,000
-
(200,000)
-
-		 At
31.3.25
£
605,411
250,000
330,250
1,185,661
1,185,661
Movement
in funds
£
602,778
-
602,778
At
31.3.24
£
2,633
250,000
330,250
582,883
582,883

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Docusign Envelope ID: D938B470-57F9-4C79-817D-14998106EBFF

GMDN AGENCY

NOTES TO THE FINANCIAL STATEMENTS - continued FOR THE YEAR ENDED 31 MARCH 2025

14. MOVEMENT IN FUNDS - continued

Comparative net movement in funds, included in the above are as follows:

Unrestricted funds
General fund
TOTAL FUNDS		 Incoming
resources
£
1,269,660
1,269,660		 Resources
expended
£
(1,638,076)
(1,638,076)		 Movement
in funds
£
(368,416)
(368,416)

The Charity has the following restricted funds:

The Innovate UK Fund is a grant received to be used towards labour costs for transforming postmarket intelligence to safely accelerate medical device innovation and adoption.

The Charity has the following designated funds:

The Designated Cash Flow Fund ("Operational Reserve") is held to cover cash flow variability and anticipated short-term variations in either income or expenditure. It also needs to cover the cost of winding up the Agency subject to the possibility that the Agency needs to be closed.

The Designated Reserve Fund ("Strategic Reserve") is held to cover anticipated needs over and above those accommodated by the Operational Reserve but required to support the long-term sustainability of the Agency. This needs to be consistent with the conditions applied above.

The level of these reserves will be agreed on an annual basis by the Trustees as part of the annual financial budgeting process.

15. EMPLOYEE BENEFIT OBLIGATIONS

The company operates a defined contribution pension scheme. The pension costs charged to the income statement represent contributions payable by the company to the fund in the year and amounted to £43,738 (2024 - £42,887). This is prior to any capitalisation of costs in respect of the development of the database. Pension commitments included on the statement of financial position at the year end date amount to £9,644 (2024: £7,114).

16. RELATED PARTY DISCLOSURES

There were no related party transactions for the year ended 31 March 2025 (2024: £Nil).

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GMDN AGENCY

NOTES TO THE FINANCIAL STATEMENTS - continued FOR THE YEAR ENDED 31 MARCH 2025

17. ULTIMATE CONTROLLING PARTY

The charity was under the control of the trustees throughout the current and previous year.

18. COMPANY LIMITED BY GUARANTEE

The liability of each member is limited to an amount not exceeding £10.

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