Terms and Conditions

1. Scope of Application

Application Area

These General Terms and Conditions (GTC) apply to all sales made through our online shop, by phone, or via email between 24protection GmbH (hereinafter referred to as “we” or “us”) and our customers (hereinafter referred to as “Customer”). They specifically regulate the sale of in-vitro diagnostic products (IVD products) as defined by Regulation (EU) 2017/746 (IVDR).

Target Groups

Our offers are exclusively aimed at:

• Healthcare professionals authorized by Regulation (EU) 2017/746 (IVDR) to purchase and use in-vitro diagnostic products (IVD products).

• Certified medical facilities authorized to use IVD products in their activities.

• Dealers as defined by the IVDR regulation, authorized to resell IVD products.

Private individuals or other non-qualified buyers are excluded from purchasing our products. Proof of authorization may be requested prior to the conclusion of the contract.

Validity of Conditions

By using our online shop, placing a phone order, or ordering via email, the customer acknowledges these GTC in their respective valid form. Diverging conditions from the customer are only valid if we expressly agree to them in writing.

Regulations for IVDR Products

The sale and use of IVD products are subject to specific legal regulations. Customers are obliged to comply with the legal requirements and the product instructions for use. The Customer is responsible for the correct usage and any reporting obligations in the event of incidents.

Extended Applicability

These GTC also apply to all future contracts and business relationships with the customer without the need for a new explicit agreement. Changes or additions to these clauses shall only apply to future contractual agreements and do not affect existing contracts.

Diverging conditions from the customer or supplier that we do not explicitly acknowledge are non-binding for us, even if we do not explicitly object to them.

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2. Offer / Conclusion of Contract

Non-binding Offers

Our offers are non-binding and without obligation unless expressly agreed otherwise.

No Legal Offer in the Online Shop

The presentation of our products in the online shop does not constitute a legal offer. A contract is only formed when the customer places an order, and we accept it by delivering the goods.

Copyright on Documents

We reserve all rights to all offers, cost estimates, drawings, and other documents. These may not be copied or made available to unauthorized third parties without our express consent. In the event of a violation of this obligation, we reserve the right to assert claims for damages and injunctive relief.

No Contract for Non-Dispatched Products

A purchase contract is only valid for those products that we actually dispatch.

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3. Prices and Payment Terms

Our prices are quoted as net prices and are plus the value-added tax applicable in the recipient country on the day of delivery. The VAT is itemized separately in our invoices.

For deliveries to countries outside the European Union, customs fees and other import duties may additionally apply, which are to be borne by the recipient.

Due Date and Payment of Invoices

Invoices are to be paid within 10 days of receipt of the goods without any deductions. The receipt of payment or a credit to our account is decisive for the timeliness of the payment.

Payment by Direct Debit

For payments by direct debit, the specified account will be charged no earlier than with the dispatch of the goods.

Payment by Credit Card

For credit card payments, the amount will be charged upon dispatch of the goods. The customer is responsible for ensuring that the credit card provided is valid and sufficiently funded at the time of the charge.

Payment via Klarna

If the customer selects the payment method Klarna, the GTC and data protection provisions of Klarna also apply. Klarna handles the processing of the payment, and we transfer the claim to Klarna. Consent to Klarna's terms is required for the use of this payment method.

Payment via PayPal

When selecting the payment method PayPal, the processing will be through the payment service provider PayPal (Europe) S.à r.l. et Cie, S.C.A. (hereinafter referred to as "PayPal"). The customer will be redirected to PayPal's site during the ordering process. The charge to the PayPal account occurs immediately after the completion of the purchase transaction. The GTC and data protection policies of PayPal apply to the use of this payment method.

Purchase on Invoice

A purchase on account is granted only to certified public medical institutions.

Payment Default

According to § 286 Abs. 3 BGB, the customer is in default at the latest 30 days after receipt of the invoice without the need for a formal reminder. In the event of payment default:

• Default interest at a rate of 8% above the respective base interest rate is payable.

• Default interest is due immediately.

• If we can prove that we pay a higher interest rate on overdue balances, this higher rate shall apply.

• We reserve the right to assert further damages for default (e.g., reminder costs).

Further Claims

The assertion of further damages resulting from the default is expressly reserved.

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4. Delivery and Shipping

Shipping Costs

The currently valid shipping costs can be viewed in the "Shipping and Delivery" section. All shipping costs are quoted as net prices plus the applicable value-added tax.

Shipping to Multiple Addresses

If a centrally issued order is split among several shipping addresses, the shipping cost regulations apply separately for each address. Shipping costs will be charged accordingly for each delivery address as per the preceding regulations.

Delivery Conditions

Unless otherwise stated in the online shop or individually agreed with the customer, the delivery of freight goods is generally made “free curbside”.

Partial Deliveries

We reserve the right to make partial deliveries. The customer will incur no additional shipping costs as a result.

Transfer of Risk and Delayed Delivery

Shipping and transport are at the risk of the customer. The risk also transfers to the customer with the handover of the goods to the carrier or freight forwarder, even in the case of partial or free delivery. Claims due to a delayed delivery, particularly for damages due to delay, are excluded.

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5. Right of Withdrawal and Return

No Right of Withdrawal for In-Vitro Diagnostic Products (IVD Products)

According to § 312g Abs. 2 Nr. 1 BGB, there is no right of withdrawal for in-vitro diagnostic products (IVD products). These products are excluded from returns due to their specific properties, adherence to regulatory requirements, and their intended use by professionals unless a legitimate defect exists.

Returns in Case of Defects

Returns of IVD products are only possible in the following cases:

• The goods have a demonstrable material defect upon receipt.

• An incorrect product was delivered.

• The goods were damaged during transport.

In such cases, the customer must notify us in writing of the defect within 7 calendar days after receipt of the goods and document the defect.

Customer's Inspection Obligations upon Receipt of Goods

The customer is obliged to inspect the goods immediately upon receipt for completeness, integrity, and conformity with the order.

Visible defects or transport damages must be reported to us in writing without delay. This requires meaningful photos and a detailed description of the defect.

If the timely inspection or notification is omitted, the goods are deemed approved.

Conditions for Return

• The goods must be in unused and unopened condition unless the defect only became apparent after opening the packaging.

• A return will only occur after prior coordination with us and using the return instructions provided by us.

Exclusion of Return

• Products that have been specifically manufactured or customized for the customer are excluded from return.

• Opened or used products cannot be taken back unless a demonstrable defect exists.

• The customer is responsible for the proper storage of the products after receipt. Damage or defects resulting from improper storage or handling exclude a return.

Costs of Return

If the return is due to a legitimate defect, we will cover the return shipping costs. In all other cases, the customer bears the return shipping costs.

Liability and Refund

After receipt and inspection of the returned goods, a credit will be issued or an exchange will be made to the customer if a legitimate claim exists. We reserve the right to assert claims for damages caused by the customer.

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6. Warranty and Liability

Warranty

Material Defect Liability
The statutory warranty regulations according to §§ 434 ff. BGB apply to the sold in-vitro diagnostic products, unless otherwise specified below.

Claims for defects by the customer require that the goods were defective at the time of risk transfer and that the customer has properly fulfilled their inspection and notification obligations according to our GTC (see Inspection Obligations).

Exclusion of Warranty

The warranty is excluded for damages resulting from improper storage, handling, usage, or manipulation by the customer.

For products with a specified expiration date or a certain shelf life, the warranty expires if they are not used within the intended period.

Rectification and Replacement

In the case of legitimate defects, the customer has the right to rectification or replacement at our discretion.

If rectification or replacement fails, the customer is entitled to reduce the purchase price or withdraw from the contract.

Claims for damages due to a defect are only permissible within the limitations of liability specified in these GTC.

Liability

Fundamental Liability
We are fully liable for damages caused by intent or gross negligence, as well as for damages arising from injury to life, body, or health.

For slight negligence, we are only liable if essential contractual obligations (cardinal obligations) are violated. In this case, our liability is limited to foreseeable and contract-typical damage.

Exclusion of Liability

Any further liability, particularly for indirect damages, consequential damages, or lost profits, is excluded unless mandatory legal provisions stipulate otherwise.

We are not liable for damages caused by improper use, non-compliance with the instructions for use, or legal regulations by the customer.

Product Liability

Liability under the Product Liability Act remains unaffected.

Any liability for damages caused by improper transfer, storage, or use of the products by third parties is excluded.

Customer Responsibility

The customer is obliged to use the delivered products only in accordance with the respective instructions for use and legal provisions.

Products may only be used in expressly approved application areas. Use outside of these areas is at the customer’s own risk, and any liability on our part is excluded.

The customer is responsible for the proper storage and transfer of the products, particularly regarding compliance with the prescribed conditions (e.g., temperature, humidity).

Documentation and Proof

The customer is obliged to document the proper application and use of the delivered products. This includes compliance with the instructions for use as well as all relevant regulatory provisions.

In the event of claims for defects, the customer may be required to provide appropriate proof of the proper application of the products. If such documentation or proof is omitted, we reserve the right to reject claims for defects.

Limitation Period

Claims under warranty expire 12 months after delivery of the goods unless longer statutory periods are prescribed.

Liability for Content and Availability of the Online Shop

We assume no liability for the continuous availability of our online shop or for any errors arising from technical problems.

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7. Special Regulations for IVDR Products

Compliance with EU-IVDR

All in-vitro diagnostic products offered by us comply with the requirements of Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR). The customer is obliged to adhere to the provisions of the IVDR when applying, transferring, and storing the products.

Use by Professionals and Proof Requirement

Some of our products are only approved for use by professionals, such as certified medical facilities, healthcare professionals, or dealers according to the IVDR.

Before purchasing such products, we reserve the right to require proof of the customer’s authorization to ensure that the products are used exclusively by qualified individuals or institutions.

The customer is obliged to ensure that the products are not passed on to unauthorized third parties.

Reporting Obligations in Case of Adverse Events or Product Issues

The customer is obliged under the provisions of the IVDR to report all adverse events or potential product issues that occur during use immediately to the relevant authorities.

Additionally, we ask our customers to inform us as the manufacturer or dealer about such events without delay so that we can initiate the necessary measures.

Information on how to contact us in case of product issues or adverse events can be found on our website or in the accompanying product documents.

Product Traceability

In accordance with the requirements of the IVDR, the customer is obliged to ensure the traceability of the purchased products. This includes recording product information, including serial numbers, batch numbers, and other relevant identification features.

At the request of authorities, manufacturers, or dealers, the customer must keep and provide traceability data for a specified period.

Audit Requirements and Customer Obligations

The customer agrees to participate in audits or inspections required for compliance with the IVDR by authorities or manufacturers.

This includes providing all relevant documents, records, and proof for the safe and compliant use of the products.

Should irregularities be found, the customer agrees to promptly correct them and cooperate in implementing necessary measures.

Customer Responsibility

The customer is responsible for using the products in accordance with the instructions for use, legal provisions, and IVDR regulations. Improper use can not only compromise safety but also have legal consequences.

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8. Final Provisions

Applicable Law

Only the law of the Federal Republic of Germany applies to all legal relationships between us and the customer, excluding the UN Convention on Contracts for the International Sale of Goods (CISG).

Jurisdiction

The exclusive jurisdiction for all disputes arising from or in connection with these General Terms and Conditions and contractual relationships is Ulm.

Severability Clause

Should individual provisions of these General Terms and Conditions be or become ineffective, the validity of the remaining provisions shall remain unaffected. Instead of the ineffective provision, the statutory provisions shall apply, or, if no suitable statutory provisions are available, a regulation that most closely approximates the economic purpose of the ineffective provision shall apply.