Terms of Sale & Licence
Terms of Sale & Licence for MiBB Regulatory template kits
Version 1.0 · Last updated: 22 October 2026 · Business customers only
1. Who we are and what these terms cover
The seller is MiBB Regulatory ApS, Lindegaardsvej 12A 2.tv., 2920 Charlottenlund, Denmark, CVR 46526155, VAT no. DK46526155. Email: info@mibb-regulatory.eu.
These terms apply to every purchase of template kits on mibb-regulatory.eu, currently the SaMD Classification Kit (MDR Rule 11), the SaMD Technical Documentation Kit and the Bundle (the “Kits”). They also contain the licence under which you may use the Kits. The Disclaimer forms part of these terms. Free resources, such as the Top 25 checklist, are covered by the Disclaimer and their own licence note, not by sections 3–7.
2. Business customers only
We sell only to businesses and other organisations, never to consumers. By ordering, you confirm that you are acting on behalf of a business (or a public body or other organisation) for purposes related to its trade or profession, and that you are authorised to accept these terms for it. You must give the company’s legal name and a valid VAT ID (or equivalent tax ID) at checkout. The organisation named at checkout is the buyer and the licensee (“you”).
Because the Kits are sold business-to-business, the consumer rules of the Danish Consumer Contracts Act, including the 14-day right of withdrawal, do not apply. If we find that an order was placed by a consumer, we may cancel it and refund the price.
3. Prices, VAT and payment
Prices are in euro (EUR) and exclude VAT. VAT is added at checkout where it applies. EU business buyers outside Denmark with a valid VAT ID are invoiced under the reverse-charge mechanism. Danish buyers are charged 25% Danish VAT. Business buyers outside the EU are not charged Danish VAT, and any local taxes or duties are the buyer’s responsibility. Our VAT number is DK46526155. Payment is taken by card through Stripe when you place the order. You receive an invoice by email.
4. Ordering and delivery
The contract is formed when your payment is confirmed. The Kit is delivered digitally, as a download sent by email to the address you give at checkout, normally within a few hours and at the latest within two business days. There is no physical delivery. If you have not received your Kit within two business days, check your spam folder and email info@mibb-regulatory.eu.
5. No refunds after delivery
Digital files cannot be returned once delivered. Purchases are therefore final, and we do not give refunds once the Kit has been delivered, including if you change your mind or the Kit does not suit your device or project.
The exceptions are:
- Not delivered: if we have not delivered the Kit within five business days of payment, you may cancel and we will refund the price in full.
- Defective files: if a file is corrupted, cannot be opened in current versions of Microsoft Word or Excel, or the Kit is materially different from its description on the website, we will send a corrected file or the correct Kit. If we cannot do this within a reasonable time, we will refund the price of the Kit concerned.
- Please report defects to info@mibb-regulatory.eu within 30 days of delivery, with your order number.
6. Your licence
The Kits and their content are protected by copyright and remain the property of MiBB Regulatory ApS. When we receive full payment, MiBB Regulatory ApS grants you a non-exclusive, non-transferable, perpetual licence to use, copy and adapt the Kit within one organisation (the legal entity named at checkout), as follows:
- Permitted: use for your own medical devices and your own quality management system, at all your sites and by your employees, and by contractors working on your own products.
- Group companies: affiliates and other group companies need their own licence, unless we agree otherwise in writing.
- Not permitted: resale, sublicensing, redistribution, publishing or sharing the templates (original or modified) as templates; using them to deliver consultancy or services to third parties; including them in training courses, products or template libraries offered to others; uploading them to public repositories or using them to train AI models.
- Your completed documents are yours: documents you complete from the templates for your own device belong to you, and you may submit them to Notified Bodies, competent authorities, auditors and customers.
If you materially breach the licence, for example by redistributing the templates, the licence ends automatically and we may claim compensation under Danish law.
7. Updates
For 12 months from the purchase date, you receive free minor updates (versions 1.x) of the Kit you bought, sent by email to the purchase email address, each with a changelog. New major versions (2.0 and later) and new Kits are not included. After 12 months you keep using the version you have.
We monitor changes to the MDR, MDCG guidance, harmonised standards and the AI Act and aim to reflect relevant changes in updates, but we do not promise that any version is complete or current at the time you use it.
8. What the Kits are – and are not
- The Kits are general guidance templates. They are not legal or regulatory advice, and buying them does not create a consultancy relationship.
- No guarantee of outcome: using the Kits does not guarantee acceptance by a Notified Body, a successful conformity assessment, CE marking, certification, or approval by any authority.
- You stay responsible: as manufacturer you remain solely responsible for your technical documentation, your quality management system and compliance with Regulation (EU) 2017/745 (MDR), Regulation (EU) 2024/1689 (AI Act) and all other applicable requirements. You must adapt the templates to your device and have the completed documents reviewed by qualified people.
- Check that references are current: regulations, harmonised standards and MDCG guidance change. Before relying on a reference, you must check that it is the current version.
- Standards: the Kits cite ISO/IEC and EN standards by clause number only and do not reproduce their text. You need your own licensed copies of the standards you apply.
- MiBB Regulatory ApS is independent and is not affiliated with, or endorsed by, any Notified Body.
We warrant only that the Kit, when delivered, materially matches its description on the website. Otherwise the Kits are provided “as is”, and all other warranties, including fitness for a particular purpose, are excluded to the extent the law allows.
9. Limitation of liability
- Our total liability arising from or in connection with a Kit, whether in contract, tort or otherwise, is limited to the price you paid for that Kit.
- We are not liable for indirect or consequential loss, including lost profit, lost revenue, delayed market access, loss of data, the cost of additional Notified Body or authority review, recalls, or claims from third parties.
- These limits do not apply where we have acted intentionally or with gross negligence, or where liability cannot otherwise be limited under mandatory Danish law.
10. Events outside our control
We are not responsible for delays or failures caused by events outside our reasonable control, such as failures of payment, hosting or email providers, network outages, or acts of public authorities.
11. Personal data
We process the personal data you give at checkout to deliver the Kit, invoice you and keep our accounts. See our privacy notice.
12. Changes to these terms
We may update these terms for future orders. The version in force when you placed your order applies to that order.
13. Governing law and disputes
These terms and every purchase are governed by Danish law, excluding the UN Convention on Contracts for the International Sale of Goods (CISG). Any dispute is to be settled by the Danish courts, with the Copenhagen City Court (Københavns Byret) as the court of first instance.
14. Contact
Questions about the Kits or a problem with your purchase: info@mibb-regulatory.eu. MiBB Regulatory ApS, Lindegaardsvej 12A 2.tv., 2920 Charlottenlund, Denmark, CVR 46526155, VAT no. DK46526155.