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The quality of the products is guaranteed by the design, manufacture and quality management in accordance with the harmonized European Union legislation.

BIONIKA Medline Orvostechnikai Kft. operates in accordance with the EN ISO 9001 and the EN ISO 13485 quality management systems. Our products are CE-marked, which is certified by EMKI.
We offer a 10-year long-term guarantee for the products we manufacture.
After implantation, reducing the medical risk of the ossification process, regardless of the causal relationship, we provide an immediate replacement guarantee within one year of purchase to our fallen, dropped implants.


1. Warranty

In which cases may you exercise your warranty rights?

In the event of a defective performance of Bionika Medline Kft., you may enforce a warranty claim against the company in accordance with the provisions of the Civil Code.

What are your rights under your warranty claim?

You – at you discretion – may enforce the following warranty claims: You may claim a repair or a replacement unless the fulfillment of the chosen claim is impossible to meet or would result in disproportionate additional costs to the company compared to satisfying a different claim. If you did not claim or could not request a repair or a replacement, you may claim a proportionate reduction of the price, may repair the defect yourself or have it repaired by somebody else at the company’s expense, or – finally - also cancel the contract. You may also switch from the chosen warranty right to another, but you will bear the costs caused by the switch unless it was justified or caused by the company.

What is the deadline for enforcing your warranty claim?

Following the detection of the defect, you are obliged to communicate the defect without delay but not later than two months from the detection of the defect. Please note that your claim of warranty lapses after two years from the time of performance.

Whom may you enforce your warranty claim against?

You may enforce your warranty claim against the Company. What other conditions are there for enforcing your warranty rights? Within six months after performance, there is no other condition except for communicating the defect, if you prove that the product or service was provided by the company BIONIKA Medline Kft. However, after six months from the date of performance, you are obliged to prove that the defect you discovered had existed at the time of performance.

2. Product warranty

In which cases may you exercise your product warranty rights?

In the event of a defect in a movable asset (product) you – at your discretion - may enforce your right defined in Section 1 or a product warranty claim.

What are your rights under your product warranty claim?

As a product warranty claim, you may only demand the repair or replacement of the defective product.

When is the product considered defective?

The product is defective if it does not comply with the quality requirements applicable at the time of placing the product on the market, or if it fails to have properties indicated in the description provided by the manufacturer.

What is the deadline for enforcing your product warranty claim?

You may enforce your product warranty claim within two years after the manufacturer placed the product on the market. The expiry of this time causes the forfeiture of rights.

Against whom and under what conditions may you enforce your product warranty claim?

You may enforce your product warranty claim only against the manufacturer or distributor of the product. In case of enforcing a product warranty claim, you must prove that the product is defective.

In what cases is the manufacturer (distributor) exempt from the product warranty obligation?

The manufacturer (distributor) is exempt from the product warranty obligation if it proves that it has not produced or distributed the product within its business activities or - the defect was not recognisable given the state of scientific or technical knowledge when the product was placed on the market or -the product’s defect was caused by the application of a law or a mandatory authority provision. It is sufficient for the manufacturer (distributor) to prove only one of these reasons to be exempt. Please note that due to the same defect, you may not enforce warranty and product warranty claims at the same time. However, in the event of a successful enforcement of your product warranty claim, you may enforce your warranty claim against the manufacturer on the replaced product or repaired part.