Trading with Medicoteknik
Here you can find the trading conditions for trading with medical equipment and systems.
STANDARD CONDITIONS FOR REGION SYDDANMARK Version: 17.02.2023
(THE REGION OF SOUTHERN DENMARK)
- For purchase and delivery of medico-technical appliances
1.1. These standard conditions have been drafted for the purpose of purchasing made by Region Syddanmark.
1.2. These standard conditions shall apply unless specifically derogated from by written agreement between the Customer and the Supplier. If the purchase is governed by a contract or framework agreement, including if the contract or the framework agreement has been entered into after public procurement, these standard conditions only apply where and to the extent this appears from the contract, the framework agreement or the tender conditions.
1.3. The ”Customer” shall in the following mean the region(s) or the unit(s) of the region that have entered into an agreement with the Supplier.
1.4. The ”Supplier” shall mean the party with which the Customer has entered into an agreement about a purchase. If the Supplier uses sub-suppliers for the performance of the agreement, the Supplier is responsible for the correct performance of the agreement to the same extent as if the Supplier had performed the delivery itself. The Supplier is thus liable for services from sub-suppliers in the same way as for its own services.
1.5. ”Goods” shall mean consumer goods, technical equipment, medico-technical appliances and other physical products. ”Services” shall mean a performance provided by the Supplier. If in addition to the performance, a service also contains components, spare parts or similar, the relevant provisions in these standard conditions shall apply to delivery of goods in relation to such components, spare parts etc.
1.6. If there is disagreement between the Customer and the Supplier whether a service is to be categorised as a ”service” or ”goods”, the Customer can decide this based on a factual assessment.
1.7. ”Working Days” shall mean Monday to Friday apart from official Danish public holidays, the day of Christmas Eve, New Year's day and Constitution Day. The first of May is not a holiday.
1.8. The Supplier and its services/products must comply with the relevant rules applicable at any time under Danish law (laws, executive orders and provisions), including but not limited to rules on EU labelling and rules on labelling of medical equipment.
1.9. The Supplier, its employees and any sub-suppliers and their employees must, within the framework of the law, maintain absolute confidentiality about information regarding matters pertaining to the Customer and other parties that they obtain knowledge of in connection with the performance of this agreement.
1.10. The Supplier may use the Customer as a general reference, including in connection with tenders. By contrast, the Supplier must not, without the Customer’s prior written consent, release public statements about the agreement or make public anything about the contents of the agreement and neither must the Supplier use the Customer in connection with advertising without the Customer’s prior written consent.
2.1. Quality/quantity
2.1.1. In addition to the provisions in these standard conditions, other/further terms may have been agreed between the Customer and the Supplier as part of the agreement and in accordance with the above section 1.2, including e.g. terms in relation to quality, environmental aspects, shipping, packaging, labelling etc.
2.1.2. All delivery of goods must include a delivery note stating the Supplier’s item number and item description, quantity, the Customer’s order number, the name and number of the requisitioner, EAN/GLN number and delivery address (as stated in the order – receipt of goods and department).
2.1.3.Services must include a work sheet specifying the services performed, hours spent, mileage etc., delivery of goods etc. with item description and quantity, the name of the recipient and place of performance, as well as the Customer’s order and requisition number, EAN/GLN number, the name of the requisitioner and personal reference number.
2.1.4. Specific safety conditions in relation to the delivery or parts thereof must be informed in writing in Danish or English to the Customer who will be entitled to require special labelling of such goods.
2.1.5. At services relating to service, repairs etc., the Supplier must prepare a service/repairs report specifying the services/repairs that have been made, any spare parts that have been replaced, the defects that have been detected and how these have been remedied.
2.1.6. Software updates and upgrades (errors and safety)
The Seller must implement all updates and upgrades free of charge that are made commercially available by the manufacturer with the purpose of correcting errors or prevent safety issues in the actually delivered software throughout the entire working life of the equipment, however for a maximum of 10 years.
The Seller must provide implementation thereof within 3 months after official release.
2.2. Delivery
Delivery takes place when the goods are made available for the Customer in the right amount and condition and in undamaged packaging at the place designated by the Customer.
For services specifically applies that delivery has been made when they have been completed, cf. section 2.1, at the place designated by the Customer, however see below.
However, if the delivery includes installation and/or mounting and/or programming, delivery will only take place when the Customer has approved the testing, cf. sections 2.2.3 and 2.2.4.
2.2.2. For goods applies that the Supplier must arrange for and pay for the delivery and insurance of the goods to the place designated by the Customer. The risk of accidental loss of the delivery passes to the Customer when the goods are delivered, cf. section 2.2.1.
2.2.3. If the delivery includes installation and/mounting and/or programming, the Supplier must, irrespective of what is otherwise stated in these standard conditions, test the delivery and report this in writing to the Customer once the work has been performed. Within 10 Working Days, the Customer must either approve the performance of the delivery in writing or convene a handover procedure and the Supplier is under an obligation to participate in this. On delivery of X-ray equipment, a report of reception control carried out under SIS’s rules must be enclosed. The Supplier is responsible for commenced registration with SIS.
If the Supplier does not attend the handover procedure, the Supplier must accept the Customer’s conclusions and assessments.
The Customer must approve the delivery of the goods once the handover procedure has taken place unless material defects are detected in the delivery at the handover procedure, however see below.
If the delivery is found to be defective, the Customer is entitled to demand a proportionate reduction for such defects.
If the delivery has significant defects, or the Customer considers the sum of insignificant defects to be significant, the Customer is entitled to either refuse the delivery until the issues in question have been rectified or demand a proportionate reduction for the defects.
If material defects have been detected and the Customer has refused the delivery, a new handover procedure must take place once the Supplier has informed the Customer in writing that the defects have been rectified. Rectification must be made within a reasonable time; otherwise, the Customer may terminate the purchase, cf. section 4.
If material defects have been detected and the Buyer has demanded a proportionate reduction, the handover procedure is approved with these defects once the parties have agreed in writing a reasonable proportionate reduction.
The Supplier pays its own expenses in connection with performance of the handover procedure.
2.2.4. If the Customer puts the entire delivery or parts thereof into service before the handover procedure and without prior agreement with the Supplier, the risk of the delivery or the parts put into service passes to the Customer from the date of commencement of use. In these cases, the rectification period for the delivery or the parts put into service, cf. section 4.4, is calculated from the date of commencement of use.
2.3. Instructions/user manual
2.3.1. According to agreement with the Customer, the Supplier must instruct the Customer’s employees to the extent that such instructions are necessary for the Customer’s correct use of the equipment. For medico-technical appliances, the employees, including medico-technical employees, must receive careful instructions/training in the operation, cleaning and maintenance/servicing of the appliances and this can be repeated after approx. one month of use if required by the Customer.
2.3.2. When purchasing goods that must be operated in a certain way in order to function correctly, the Supplier must provide operating instructions in Danish to the Customer upon delivery.
- The operating instructions must be prepared with a view to
ensuring correct and optimal operation and safe use of the goods; - preventing incorrect use that may damage the goods;
- ensuring correct cleaning and maintenance,
- showing the utmost consideration for the user and third parties; and
- ensuring that otherwise faultless goods function in accordance with the intended use
Upon delivery, a set of technical manuals, the necessary diagrams and a list of essential spare parts in Danish or English must be provided.
- Medico-technical appliances must also be accompanied by the following:
The original operating instructions (hard copy and PDF) - A complete service manual including functional descriptions, block diagrams, detail diagrams, software descriptions, test programmes, adjustment and maintenance instructions and spare parts lists etc. in English, German, Norwegian or Swedish.
- Approved installation test (PDF)
2.4 Service organisation and telephone support
2.4.1. Service calls.
Throughout the entire working life of the equipment (however, for a maximum of 10 years), the Seller must be able to provide the necessary service at specialist level, also in case of retirement, sickness or other long-term absence among the experts who are part of the Supplier’s service setup. Service calls must be accommodated by the Supplier on all working days during normal opening hours from 8 am to 4 pm Monday-Thursday and Friday from 8 am to 2 pm on days that are not public holidays. Public holidays are defined as public holidays in Denmark.
2.4.2. The Seller guarantees a response time for on-site service calls of maximum 16 working hours.
2.4.3. Telephone support.
The Seller must – whether or not an agreement for service has been made – provide telephone support free of charge concerning basic operation and preliminary detection and identification of defects in the equipment or the product as long as the equipment/product has utility value for the Buyer, however for a maximum of 10 years.
The Seller guarantees a response time for telephone support of maximum 4 working hours as long as the equipment has utility value for Region Syddanmark; this also applies during the rectification period and/or guarantee period.
3.1. Pricing
3.1.1. The prices agreed are ex VAT in Danish kroner but inclusive of any other taxes (customs etc.).
3.1.2. The prices include all costs related to the deliveries, including delivery, installation service and support as well as any fees etc. unless otherwise agreed in writing between the Parties.
3.2. Payment
3.2.1. Terms of payment are 30 days from date of invoice provided that the Customer has received a satisfactory electronic invoice. The invoice date cannot be earlier than the delivery date.
3.2.2. The invoice is submitted electronically according to the relevant legislation applicable at any time.
The invoice must state invoice date and number, the Supplier’s name, address and CVR no, order number/requisition number, the Customer’s EAN/GLN numbers, personal reference/personal reference number with the Customer, the Customer’s name and address, date of delivery, place of delivery, description of the goods and services, item number, prices (with and without VAT) and quantity. For services, also the hours spent and the hourly rate, any mileage etc. are stated.
4.1. Unless otherwise stated, the general provisions of Danish law shall apply to the Supplier’s breach.
4.2. Delays
4.2.1. If the Supplier does not deliver on time, this will constitute a delay. This applies whether or not the entire delivery is delayed or only parts thereof are delayed.
If the Supplier anticipates a delay in the delivery, the Supplier must immediately inform the Customer in writing about the reason for the delay and about the anticipated duration/extent of the delay. Based on this, a new time of delivery can be agreed provided that the Customer can accept this. The Customer may also choose to terminate the agreement, cf. section 4.2.2.
4.2.2. The Customer regards any delay as significant. If the Supplier does not deliver on time, the Customer shall therefore be entitled to terminate the agreement in its entirety or partially irrespective of the duration of the delay.
4.3. Defects
4.3.1. The Delivery is deemed to be defective if the Delivery does not comply with the requirements set out in the agreement or if the Delivery does not correspond to what the Customer may reasonably expect.
4.3.2.
The Customer must submit a written claim within a reasonable time after the Customer has established that the delivery was defective in order to claim remedy for breach under sections 4.3 and 4.4.
4.3.3. The Customer is entitled to refuse the delivery and to terminate the agreement in whole or in part if delivery was found to be defective and if such defects are not rectified within a reasonable time, cf. section 4.4.
4.3.4. Notwithstanding the provision in the section about rectification, the Customer is entitled to demand that the Supplier covers all documented losses inflicted on the Customer due to the delivery being defective.
4.4. Retification
4.4.1.For a minimum of 1 year from delivery, the Supplier is entitled to and under an obligation to provide corrective actions free of charge of defects or replacement delivery within a reasonable time unless the agreement is terminated due to the defect according to section 4.3.
4.4.2. Without undue delay, the Supplier must commence corrective actions when the Supplier has received the Customer’s claim.
4.4.3. The Supplier pays all expenses in connection with the rectification. This also applies if the Customer and the Supplier agree to let a third party carry out corrective actions.
4.4.4. If, despite being requested in writing, the Supplier fails to fulfil its obligation to rectify, cf. the above, the Customer is entitled to terminate the agreement, cf. sections
4.3.3 and 4.3.4.
4.4.5. If the delivery or parts thereof are found to be defective due to faulty design, the Supplier’s obligations according to section 4.4.1 are extended by the time in which the delivery has utility value for the Customer – however, no longer than 10 years after the handover of the delivery/the approved handover procedure.
4.4.6. If a part of the delivery has to be replaced during the rectification period, a new 1-year rectification period shall apply from the time of replacement for the replaced part. If a material part of the delivery is replaced during the rectification period, a new 1-year rectification period shall apply for the entire delivery from the time of replacement.
4.4.7. The Supplier must be able to deliver all spare parts necessary for the operation of the goods included in the delivery as long as they have utility value for the Customer – however, maximum 10 years from delivery.
4.5. Third party rights
4.5.1. The Supplier guarantees that the Supplier’s services do not infringe other parties’ rights, including property rights, patents or copyrights. The Supplier must indemnify the Customer for all claims, including legal costs, made against the Customer due to any infringements. The Customer cannot make a settlement with third parties about such claims without the involvement of the Supplier.
4.6. Product liability and liability for damages
4.6.1.Under the general provisions of Danish law on damages, Danish law on product liability and the general provisions of Danish law on product liability, the Supplier is liable to the Customer for any damage inflicted on the Customer by the delivery or the Supplier. However, for damage to movable property and immovable property, a limitation of liability of 2 million Danish kroner per loss occurrence applies.
4.6.2. The limitations in section 4.6.1 only apply provided the loss cannot be attributed to gross negligence or intentional acts from the Supplier.
4.6.3. The Supplier must also, without limitation, indemnify the Customer for all claims, including legal costs, made against the Customer by third parties and caused by errors or defects in the delivery, injury caused by a defective product or the Supplier’s tortious acts. The Customer cannot make a settlement with third parties about such claims without the involvement of the Supplier.
4.6.4. If a claim is made against the Customer due to matters pertaining to the delivery, the Supplier must let itself be sued at the same time before the court of law hearing the claim for damages made against the Customer.
4.6.5. The Supplier must maintain the usual general liability insurance and the product liability insurance to cover the Supplier’s liability in relation to the delivery. At the Customer’s request, the Supplier must document the existence and scope of such insurance. This can be done by producing the insurance policy and documentation that the insurance has been paid.
4.7. Force majeure
4.7.1. The Supplier is responsible for breach of contract unless the breach is owing to matters for which the Customer bears the responsibility or the risk or is owing to force majeure.
4.7.2. A force majeure situation exists when correct performance of the agreement is impossible and this is owing to extraordinary circumstances that the Supplier is not able to remedy and ought not to have been able to anticipate, such as war, acts of God, pandemic, fire, strike or lockout. With respect to strike and lockout, it is a condition that these do not only affect the Supplier’s business. The Supplier must, to the widest possible extent, maintain an emergency response plan.
4.7.3. The Customer is exempt from liability under the same conditions as the Supplier, cf. sections 4.7.1-4.7.2.
4.7.4.Force majeure can only be claimed if the Party in question has given information to this effect to the other Party no later than 5 Working Days after the occurrence of the force majeure event. If the Supplier claims force majeure, the information to the Customer must contain the following:
- a complete description of the circumstances that make the Supplier claim force majeure, including a description of what the Supplier has done to avoid the situation;
- information about the services (with item numbers) affected by the force majeure; and
- information about the exact effect of the force majeure situation on the Supplier’s performance of the agreement, including how long the Supplier expects the situation to last.
The Customer may subsequently ask for further documentation of the above.
4.7.5. Force majeure in the case of delay can only be claimed with the number of Working Days that the force majeure situation lasts. When the force majeure situation ends, the Party claiming force majeure must, without undue delay, inform this to the other Party.
4.7.6. Each Party pays its own expenses and bears its own losses as a result of a force majeure event, including if the agreement is terminated due to the force majeure event.
4.7.7. If the performance of the agreement has been rendered impossible due to force majeure in its entirety or in essential respects for a continuous period of more than 45 days or for more than 70 days during a 1-year period, the Customer may choose to terminate the agreement.
4.7.8. When the force majeure event has ended, or when there are indications that the force majeure event will end, and the agreement has not been terminated under this provision, the Parties must as soon as possible together prepare a plan for how and when the terms of the agreement can be performed again by the Party who originally claimed force majeure. A reasonable time limit can be agreed between the parties for the re-establishment of deliveries under the agreement.
5.1. If the Customer is not able to receive the delivery in whole or in part at the agreed time of delivery, the Customer shall carry all documented expenses and risks in relation to this.
5.2. The Customer must inform the Supplier in writing about the delay as soon as it is considered to be impossible for the Customer to receive the delivery at the agreed time. A new date of delivery must then be agreed immediately.
5.3. If the Customer does not pay the purchase price or parts thereof on time, interest calculated from the due date shall be added in accordance with the Danish Interest Rate Act.
6.1. The Supplier is solely responsible towards the Customer.
6.2. The Supplier may only transfer its rights wholly or partially to a third party with the Customer’s written consent. The Supplier is entitled to use sub-suppliers that have been informed at the formation of contract but the responsibility for correct performance of the delivery rests entirely with the Supplier. If during the period of agreement, the Supplier wishes to change sub-suppliers, this must be approved by the Customer. The Customer cannot refuse its approval without just cause.
6.3. Only after the Customer’s written consent may the Supplier, wholly or partially, discount or transfer its receivables to third parties.
7.1. In connection with the performance of the agreement, the Supplier must respect and comply with national and international laws and rules concerning human rights, employee rights and anti-corruption based on:
- The UN Declaration on Human Rights
- The ILO’s Eight Core Conventions on Fundamental Principles and Rights at Work; and
- UN convention against corruption
8.1. If the Customer’s decision to enter into the agreement is referred to the Public Procurement Complaints Board or the courts of law, and the decision is then annulled, and/or the agreement or parts thereof is declared to be ”without effect”, or if the Customer is otherwise ordered to terminate the agreement, the agreement can be terminated – in full or in part – in writing by the Customer giving adequate notice.
8.2. Termination in accordance with section 8 only gives the Supplier the right to damages in the form of reliance damages. However, the Customer’s liability for damages in relation to termination under these provisions is in any event capped at 30,000 Danish kroner. If the termination is due to matters for which the Supplier is responsible, the Supplier shall not be entitled to damages.
9.1. This Contract shall be governed by Danish law, with the exception of Danish international private law on governing law. Neither shall the UN Convention on contracts for international trade (CISG) apply.
9.2. Disputes in relation to the agreement must be settled by negotiation between the Parties. If the Parties agree, an independent mediator can be involved to solve the dispute. The expenses for the mediator must be paid jointly by the Parties.
9.3. If it is not possible to settle the dispute by negotiation or mediation, either Party shall be entitled to have the dispute settled by the courts of law at the Customer’s venue.