Terms and Conditions of Sales (UK Private Healthcare) 13/11/2025
Version: DIG-TC-003 v1.0
1. Definitions
Digostics means Digostics Ltd, registered in England and Wales (Company No. 11797881) with its registered office at Harwell Innovation Centre, Harwell, Didcot, Oxfordshire, OX11 0QG.
Customer means the clinician, clinic, or private healthcare provider purchasing GTT@home kits from Digostics whose details appear on the purchase orders.
Product means the GTT@home diagnostic sample collection kit and associated components.
IFU means the Instructions for Use accompanying the Product.
Applicable Law means any legislation, regulation, or standard applicable in the United Kingdom relating to the sale, supply, or use of in vitro diagnostic medical devices.
ISO 13485 refers to the international standard for quality management systems for medical devices.
HCP Portal means the portal hosted for Digostics which will be accessible to the Customer where test results are stored and made available for review.
2. Scope and Application
2.1 These Terms govern all sales of GTT@home Products by Digostics to Customer for use with their patients.
2.2 GTT@home is a professional-use in vitro diagnostic (IVD) medical device and must be used only under the supervision of a qualified healthcare professional.
2.3 The Customer must not resell, distribute, or otherwise make the Product available to third parties without Digostics’ prior written consent.
2.4 No other terms or conditions (including those of the Customer) apply unless agreed in writing by Digostics.
3. Orders and Acceptance
3.1 All orders are subject to written acceptance by Digostics.
3.2 All orders must be made in writing (which with Digostics agreement may include email) and in a format approved by Digostics, including as a minimum the following information:
• Customer name and billing address
• Delivery address (if devices are to be delivered to a central location)
• Purchase order or reference number
• Quantity and description of Products ordered
• Agreed price and currency
• Requested delivery date (if applicable, subject to availability)
• Any special instructions agreed in writing
3.3 A binding contract (the Agreement) forms when Digostics issues written confirmation, delivers the Product, or raises an invoice, whichever occurs first.
3.4 Minimum order quantities may apply. Estimated delivery dates are indicative only.
3.5 Digostics may require Customer to provide indications of expected quantities of Products expected to be required over a specified period and shall in any event require reasonable notice for fulfilment of specific orders.
4. Price and Payment
4.1 Prices are stated exclusive of VAT unless otherwise indicated.
(a) Products supplied to registered healthcare professionals or healthcare organisations for use in the diagnosis, prevention, or treatment of disease are ordinarily exempt from VAT under Group 7, Schedule 9 of the Value Added Tax Act 1994.
(b) Where VAT exemption or zero-rating does not apply — for example, supplies to non-clinical distributors, for research or training use, or domestic sales not qualifying for medical exemption — VAT will be charged at the applicable rate.
(c) Exports and supplies outside the United Kingdom are zero-rated for VAT provided that satisfactory evidence of export is retained in accordance with HMRC requirements.
4.2 Payment is due 30 days from the date of invoice, unless otherwise stated on the invoice or agreed in writing by Digostics.
4.3 Digostics reserves the right, at its sole discretion, to require full or partial payment in advance for new customers, overseas purchasers, or customers with a poor payment history.
4.4 Digostics may amend its pricing from time to time on giving reasonable notice to Customer.
4.5 Title to the Product remains with Digostics until full payment is received. Risk passes to the Customer on delivery.
4.54 Late payments may incur interest under the Late Payment of Commercial Debts (Interest) Act 1998.
5. Delivery, Storage and Handling
5.1 Delivery occurs when the Product is delivered to the Customer’s nominated address or collected by the nominated carrier.
5.2 The Customer must store Products in accordance with the labelling, including any storage conditions or handling instructions specified by Digostics, and must ensure that Products remain within their stated expiry date when issued to patients.
5.3 Digostics shall not be liable for delays caused by factors outside its reasonable control, including courier or customs delays.
5.4 Products and their components must not be reused or altered. Sterile single-use lancets must not be reused under any circumstances.
6. Warranty and Returns
6.1 Digostics warrants that Products:
- conform to their specifications at the time of delivery,
- are free from material defects in manufacture or workmanship until their expiry date, - have been manufactured under an ISO 13485:2016-certified quality system, And
- GTT@home is CE-marked per Annex III of Directive 98/79/EC on in vitro diagnostic medical devices.
6.2 Due to product storage and hygiene requirements, Digostics cannot accept returns once dispatched, except for goods which are damaged or defective on delivery.
6.3 Claims for defective or incomplete deliveries must be notified within 7 days of receipt.
6.4 Digostics’ liability is limited to repair, replacement, or refund at its discretion.
6.5 Nothing in this clause limits statutory rights under the Consumer Rights Act 2015 where applicable.
7. Customer Responsibilities
7.1 The Customer shall ensure that:
- Products are used as directed by appropriately qualified healthcare professionals;
- all patient consents required by law are obtained;
- all patient and clinical data shared with Digostics is accurate and complete.
7.2 The Customer is responsible for ensuring patients complete the GTT@home test in accordance with the IFU and as requested by their healthcare professional.
7.3 The Products are intended for professional use only. The Customer confirms by placing an order that it, and any healthcare professionals under its direction who use the Products, hold appropriate professional qualifications, registrations, or authorisations required to perform diagnostic testing within their professional scope of practice. The Customer shall comply with all applicable healthcare regulations and professional standards governing the provision of diagnostic services in its jurisdiction when providing the Products to patients.
8. Confidentiality
8.1 Both parties shall treat all information obtained under this Agreement as confidential and use it solely for fulfilling their obligations.
8.2 This clause does not apply to information that is public, already known, or required to be disclosed by law or regulation.
9. Data Protection
9.1 The Customer remains the data controller for all patient data processed in connection with use of GTT@home.
9.2 Digostics acts as a data processor only to the extent necessary to manage order fulfilment, logistics, the operation of the HCP Portal and technical support.
9.3 The data collected in the HCP Portal from the test results is sensitive personal data relating to the patient. The Customer hereby confirms that it shall obtain all necessary consents from the patient as the data subject to the use of the relevant data and its processing by Digostics. Customer shall indemnify and hold harmless Digostics without limit should it breach this undertaking.
9.4 Both parties shall comply with the UK GDPR and Data Protection Act 2018.
9.5 Digostics’ Privacy Policy is available at: https://care.gttathome.com/privacy-policy and its terms where relevant are incorporated into and apply to this agreement.
10. Liability and Insurance
10.1 Digostics’ total aggregate liability for any claim arising under the Agreement in any 12 month period shall not exceed the total price paid for the Products in the previous 12 months.
10.2 Neither party shall be liable for indirect, consequential, or economic losses, including loss of profit, revenue, or goodwill.
10.3 Nothing in these Terms limits liability for death or personal injury caused by negligence, fraud, or fraudulent misrepresentation.
10.4 Digostics maintains appropriate product liability and professional indemnity insurance.
11. HCP Portal
11.1 Digostics hereby grants the Customer for the duration of the term of this agreement a non-exclusive, limited, royalty-free licence to access the HCP Portal solely for the purpose of viewing test results.
11.2 Access to the HCP Portal shall be restricted to authorised representatives of Customer and Customer is responsible for keeping safe and secure all access codes, PINs and other security devices that may be made available by Digostics for this purpose.
11.3 Digostics shall provide a technical support service for patients regarding the HCP Portla which shall be available during normal business hours.
12. Term and Termination
12.1 This agreement shall come into effect on the date that it is executed by the last party to sign and shall continue until terminated by either party giving to the other written notice of termination.
12.2 Either party may terminate this agreement forthwith by giving written notice to the other party where the other is in breach and the breach (if capable of remedy) has not been remedied within a reasonable period from demand.
12.3 On termination of this agreement for whatever reason Customer shall cease to provide the Products to patients and Digostics shall terminate Customer’s access to the HCP Portal.
13. Force Majeure
Neither party shall be liable for delay or failure to perform obligations (except payment) caused by events beyond reasonable control, including natural disasters, transport disruption, or regulatory actions. Either party may terminate if the event continues beyond 3 months.
14. Governing Law and Jurisdiction
These Terms are governed by the laws of England and Wales. Any dispute shall be subject to the exclusive jurisdiction of the English courts.
15. General
15.1 Any variation must be agreed in writing by authorised representatives of both parties.
15.2 Notices shall be in writing and sent to the registered addresses or by email to the contact designated in the order.
15.3 If any clause is held invalid, the remainder shall remain in full force.
15.4 These Terms constitute the entire agreement between the parties and supersede any prior representations or understandings.
15.5 No third party has rights to enforce these Terms under the Contracts (Rights of Third Parties) Act 1999.
End of Document