General business terms

Terms and Conditions of MPG GmbH

GENERAL

1.1. These Terms and Conditions apply to the acceptance and fulfilment of all orders placed with MPG GmbH, Liebenauer Tangente 4-6, 8041 Graz, FB number 389095z (hereinafter referred to as "MPG", "MANUFACTURER" or "us") by companies within the meaning of Section 1 of the Austrian Commercial Code (Unternehmensgesetzbuch – UGB) and legal entities under public law (hereinafter referred to as "Purchaser", "Buyer" or "DISTRIBUTOR"), unless the parties have expressly agreed otherwise. The version valid at the time the contract is concluded shall apply.

1.2. Any provisions or conditions of the Purchaser that deviate from or supplement these Terms and Conditions shall not apply unless we have agreed to their validity in writing.

1.3. In this respect, contractual fulfilment by MPG shall not be deemed to constitute acceptance of contractual terms that deviate from its Terms and Conditions. These Terms and Conditions shall also apply as a framework agreement for future legal transactions between the contracting parties, even if no express reference is made to our Terms and Conditions.

1.4. MPG and the Purchaser undertake to maintain confidentiality regarding the agreed contractual points.

OFFERS

2.1. Our offers are always subject to change and non-binding, unless they are expressly designated as binding in writing. A contract is only concluded when an order placed by the Buyer in accordance with the terms of the offer has been accepted by our written order confirmation. If the order is not confirmed separately, the delivery of the goods or the invoice, if this is sent before delivery of the goods, shall be deemed to be the order confirmation. Special instructions of the Buyer, for example with regard to delivery periods, discounts or similar, shall only be deemed to be non-binding suggestions until expressly recognised in writing by MPG as part of the order confirmation. MPG must expressly agree in writing to any change to the order by the Purchaser after conclusion of the contract and reserves the right to indemnification. MPG is entitled to refuse to accept the order - for example after checking the Purchaser's creditworthiness.

2.2. We reserve the right to make changes to our specifications for the delivered goods (e.g. weights, dimensions, tolerances, technical data or product designations) as well as to our illustrations (e.g. images), provided that there is a legitimate interest in doing so (in particular in the context of regular product changes) and the delivery item is not significantly changed or its quality increased as a result and the changes or deviations are reasonable for the Purchaser.

2.3. All agreements made between MPG and the Purchaser for the purpose of executing this contract are agreed in writing in the contract.

SIDE AGREEMENTS

Side agreements and subsequent amendments to the contract shall only be valid if they are agreed in writing by bodies authorised to represent us or by persons authorised by us. This also applies to all agreements made on our behalf by our sales representatives.

PRICES

4.1. Prices are quoted in EURO, are valid for delivery ex warehouse, unless otherwise agreed, and do not include freight costs or VAT. All fees, taxes, customs duties and other charges shall be borne by the Purchaser. Additional services shall be invoiced separately. The purchase price shall be the price stated in the order confirmation or, in the absence of an order confirmation, the price according to the country-specific standard or distributor price list valid on the day of delivery, based on our current print and online documents. The prices in the price lists valid in Switzerland are quoted in EURO or CHF. Customised products are subject to a corresponding surcharge and possibly a minimum order quantity and must be agreed separately in writing.

4.2. In the event that goods are to be delivered to a third country, MPG expressly reserves the right to subsequently charge the legally applicable value added tax if the Purchaser does not fulfil his obligation to provide proper export documentation. In the case of cross-border deliveries, the Purchaser shall bear the customs duties, fees and other charges incurred, unless otherwise agreed in individual contracts.

4.3. Partial invoices are always permissible for partial deliveries. In the event that instalments are agreed, the deadline shall be lost if even one instalment is not paid on time or in full. In the event of a missed deadline, the entire outstanding balance shall become due for payment immediately in accordance with Section 9.4. In this case, MPG is authorised to perform outstanding services only against advance payment or to withdraw from the contract after a reasonable grace period. In the event of default, we shall be entitled to take the goods delivered subject to retention of title into safekeeping without cancelling the purchase contract until the entire claim, including ancillary costs, has been covered in full.

4.4. Unless expressly agreed otherwise, the credit notes issued by MPG are valid for a period of 36 months from the date of issue.

DELIVERY

5.1. Unless expressly agreed otherwise, delivery shall be EXW (Incoterms 2020) from our warehouse in Domazlice, Czech Republic. This means that dispatch is at the risk and expense of the Purchaser.

5.2. At the Buyer's request, we will deliver the goods to an agreed destination, whereby MPG will independently determine the type of shipment (in particular the carrier, transport route, packaging). All transport and insurance costs shall be borne by the Buyer, unless expressly agreed otherwise. We have the right to adjust prices accordingly in the event of changes in procurement and manufacturing costs as well as freight and insurance costs and the introduction or change of customs duties, taxes or other levies.

5.3. We shall fulfil all orders placed with us in the shortest possible time. Unless fixed delivery dates have been expressly agreed, information on delivery periods or dates shall only be regarded as guidelines and shall be adhered to by us as far as possible. Unless otherwise agreed, the delivery period shall commence on the date of the order confirmation, but not before receipt of the documents to be provided by the Purchaser for order processing

5.4. If we or one of our suppliers are affected by a case of force majeure or an event beyond the control of MPG or its supplier (these circumstances include, but are not limited to, war, terrorist attacks, armed conflicts, natural disasters, government intervention or prohibitions, energy or raw material shortages, material shortages, strikes, lockouts, civil unrest, transport damage or transport delays and pandemics), we are entitled to postpone the specified delivery date by the duration of the hindrance if we inform the Purchaser in writing of such an event within 10 (ten) working days. The delivery period shall thus be extended by a period that takes the delaying circumstances into account in an appropriate manner.

5.5. If a delivery date cannot be met despite due diligence for reasons for which we are not responsible, in particular due to late or incorrect delivery despite careful selection of suppliers, , this shall not give rise to any claim for damages on the part of the Purchaser, including consequential damages.

5.6. If an ordered item cannot be delivered as ordered, we are entitled to refuse delivery. If an obstacle to delivery for which we are not responsible is not only of a temporary nature, we shall be entitled to withdraw from the contract. We shall inform the Purchaser immediately of the non-deliverability.

5.7. We have the right to make partial deliveries if the partially delivered goods can be used by the Purchaser for the agreed purpose, the delivery of the remaining ordered goods is ensured and neither significant additional work nor additional costs are incurred by the Purchaser as a result. An obligation to deliver the entire programme cannot be derived from the delivery of certain product groups.

SHIPPING, RISK TRANSFER

6.1. Unless expressly agreed otherwise, dispatch and transport shall be at the risk of the Purchaser. The risk shall pass to the Purchaser as soon as the consignment has been handed over to the person carrying out the transport.

6.2. Any damage to the consignment of goods must be reported by the Purchaser to the carrier without delay. The transport company must be requested to record the damage in writing. In addition, the damage must be reported to us immediately.

6.3. If the dispatch of the delivery is delayed for reasons for which the Purchaser is responsible, default of acceptance shall occur and the risk of accidental deterioration and accidental loss shall pass to the Purchaser upon notification of readiness for dispatch. Storage costs after the transfer of risk shall be borne by the Purchaser. If the Purchaser has not accepted the goods as agreed (default of acceptance), MPG is entitled, after setting a grace period to no avail, either to store the goods on its premises, for which a storage fee of 0.1% of the gross invoice amount per calendar day or part thereof will be charged, or to store them at the expense and risk of the Purchaser with an authorised trader. At the same time, MPG is entitled either to insist on fulfilment of the contract or, after setting a reasonable grace period of at least 2 weeks, to withdraw from the contract and dispose of the goods elsewhere. Further claims remain unaffected.

WARRANTY

7.1. All complaints due to defective or incomplete delivery must be notified to us in writing immediately, but at the latest within 10 working days of receipt of the goods by the Purchaser or a third party designated by him. If this obligation of inspection and immediate written notification is not complied with, all warranty claims shall lapse.

7.2. MPG shall only be liable to the Purchaser for defects that occur in compliance with the intended conditions of use and during normal use. In particular, it does not apply to defects that are due to reasons for which the Purchaser or third parties are responsible. The existence of defects must be proven by the Purchaser.

7.3. Section 924 Austrian General Civil Code (Allgemeines Bürgerliches Gesetzbuch – ABGB) shall not apply. In any case, the Purchaser shall bear the full burden of proof for all claim requirements, including the existence of the defect itself, the time at which the defect was discovered and the timeliness of the notice of defect. The Purchaser shall grant MPG the necessary time to inspect the defects and to rectify or replace the goods. Unless otherwise agreed in individual cases, the Purchaser shall bear the costs and risk of transport to and from the site. In the event of default of acceptance, the warranty period shall commence upon handover to the person carrying out the transport.

7.4. If the goods are defective, we shall first be obliged to rectify the defect, i.e. at our discretion to remedy the defect or deliver a replacement. If we are not prepared or not in a position to rectify the defect, if this is delayed beyond a reasonable period for reasons for which we are responsible, or if the rectification fails in any other way, the Purchaser shall be entitled to demand a price reduction or cancellation of the contract (rescission).

7.5. The limitation period for claims for defects is - except in the case of fraudulent intent and subject to Clause 8.6 - twelve months, calculated from delivery or, if acceptance is required, from acceptance of the goods.

7.6. The Purchaser has the right to assert recourse claims in accordance with Section 933a ABGB. Their limitation period shall be governed by the statutory provisions.

7.7. Our liability for defects occurring in our products is in any case limited to the net amount of the delivery value. In all other respects, in particular for compensation obligations, point 8 (General limitation of liability and limitation period) shall apply.

7.8. The regulation according to Section 377 UGB remains unaffected. In the event of hidden defects, MPG must be notified in writing within 10 working days of the defect being discovered.

7.9. The warranty obligation shall not be extended due to the rectification of defects. MPG shall only be liable for the rectification of defects by the Purchaser itself or by third parties if it has given its written consent.

GENERAL LIMITATION OF LIABILITY AND LIMITATION PERIOD

8.1. We shall be liable - irrespective of the legal grounds - for damages, unless these are demonstrably based on slight negligence and not on the breach of an essential contractual obligation, the fulfilment of which is essential for the proper execution of the contract and on the observance of which the Purchaser regularly relies and may rely.

8.2. Liability in the event of negligent breach of a material contractual obligation is limited to the damages and amounts foreseeable and typical for the contract at the time of conclusion of the contract, and is limited in total to the amount of the actual cover provided by an insurance policy taken out by MPG.

8.3. Liability for personal injury and under the Austrian Product Liability Act (Produkthaftungsgesetz - ProdHaftG) or other mandatory liability provisions under applicable law shall remain unaffected by the above limitations. If we assume a guarantee, we shall be liable in accordance with the statutory provisions.

8.4. Liability for all other damages is excluded, in particular for consequential damages, indirect damages and loss of profit.

8.5. Insofar as we provide technical information or advice and this information or advice is not part of the contractually agreed scope of services owed by us, this shall be free of charge and non-binding. Whether a product is also suitable for the special applications of the Purchaser is to be checked by the Purchaser himself.

8.6. Claims for damages in accordance with the above clauses 1 to 5 shall lapse within the statutory periods.

8.7. A claim for damages due to breach of the obligation to rectify in accordance with Section 933a ABGB shall only exist if, during the 12-month limitation period in accordance with Clause 7.5, both a) the Purchaser has demanded rectification and b) we have breached our obligation to rectify.

8.8. The above provisions also apply in favour of MPG's employees, representatives, subcontractors, suppliers and vicarious agents.

PAYMENTS, DUE DATE

9.1. The Purchaser agrees to the invoice being sent electronically, unless expressly agreed otherwise. Invoices from MPG must be paid within 30 calendar days of the invoice date without deduction. For payments made within 14 calendar days of the invoice date, we grant a 2% discount on the net value of the goods. Deviating payment terms or agreements as well as discount deductions require a separate express written agreement.

9.2. Discounts may only be deducted on condition that all previous invoices have been settled. Regardless of any dedication, late payment by the Buyer shall be credited first to costs, ancillary claims, then to interest and only then to the invoice value, namely to the oldest invoice first. We reserve the right to accept discountable acceptances. Discount and bill charges shall be borne by the Purchaser and must be paid immediately. If the term of payment is exceeded, interest on arrears will be charged at the statutory rate. If payment is not made by the payment date stated on the invoice, MPG shall be entitled to disregard agreed quantity discounts, price reductions and price deductions. MPG's right to claim higher damages incurred remains unaffected. Furthermore, the Purchaser is obliged to reimburse all costs and expenses associated with the collection of the claim, such as in particular reminder and collection charges or other expenses necessary for the appropriate legal prosecution

9.3. Payment agreements are only deemed to be conditionally agreed. MPG reserves the right to deliver exclusively against advance payment or presentation of a bank guarantee if it becomes aware of circumstances that are likely to reduce the creditworthiness of the Purchaser. If the Purchaser ceases to make payments or if other circumstances become apparent after conclusion of the contract which indicate a significant deterioration in the Purchaser's financial circumstances and which jeopardise our claim to payment, we shall be entitled to make outstanding deliveries and services dependent on advance payment or the provision of security or to deliver cash on delivery (delivery against payment).

9.4. If the Purchaser is more than four weeks in arrears with a claim amounting to at least 20% of all our claims against the Purchaser, we shall be entitled to demand immediate payment of all claims for deliveries and services rendered to date which are based on the same legal relationship. This shall not apply if the default is due to circumstances for which the Purchaser is not responsible.

9.5. Offsetting against counterclaims of the Purchaser or the retention of payments due to such claims is only permissible if the counterclaims are undisputed or have been recognised by declaratory judgement.

RETENTION OF TITLE, INSOLVENCY OF THE PURCHASER

10.1. We reserve title to the goods delivered by us until full payment of the purchase price including any interest and costs. The Purchaser is obliged to treat the goods with care for the duration of the retention of title. The Purchaser must notify MPG immediately in writing of any seizure of the goods by third parties, in particular in the event of enforcement measures, any damage, other extraordinary reductions in value or the destruction of the goods. In the event of a breach of these obligations and in the event of necessary intervention measures against access to the goods by third parties, the Purchaser shall reimburse MPG for all damages and costs.

10.2. If the Purchaser further processes our goods, we shall become at least co-owner of the new item. In the event of the sale of the goods subject to retention of title (processed or not), the Purchaser assigns to us the resulting claim. The proceeds from the sale of the goods supplied by us shall thus become our property immediately upon payment by the end user and shall be transferred to us.

10.3. In order to inspect the goods subject to retention of title, the Purchaser shall grant MPG access to his premises by prior appointment. In the event of breach of contract by the Purchaser, in particular default of payment, we are entitled to withdraw from the contract and demand the return of the goods. This also applies in the event of a breach of an obligation under point 10.1 by the Purchaser if MPG can no longer reasonably be expected to adhere to the contract.

CONFIDENTIALITY

11.1. All information, commercial and technical data made available to the Purchaser by us during the negotiations or during the fulfilment of the present contract shall be treated as confidential by the Purchaser, irrespective of whether they are marked as confidential or not.

11.2. The Purchaser undertakes to treat the content of this contract and its annexes, the subject matter of this contract and all confidential information which it receives from us as confidential and not to make it accessible to third parties, unless we have agreed to this in advance or disclosure is required by court or official order.

11.3. However, the Purchaser may disclose Confidential Information to the relevant regulatory authorities and its employees, affiliates or subcontractors, but only to the extent that they have a need to know and provided that such employees, affiliates or subcontractors who have access to all or part of the Confidential Information are bound by a similar duty of confidentiality and that the Purchaser requests the regulatory authority not to disclose the Confidential Information to the public to the extent permitted by law.

11.4. The Purchaser's confidentiality obligations shall remain valid after expiry or termination of the contract, for whatever reason, unless the Purchaser proves that the confidential information

I) was already published, publicly known or otherwise in the public domain at the time of its notification to the Purchaser;

II) becomes published, publicly known or otherwise in the public domain after its notification to the Purchaser, but through no fault of the Purchaser;

III) was already lawfully known to the Purchaser at the time of its notification;

IV) was provided by the Purchaser by an authorised third party who had the right to disclose such confidential information to the Purchaser; and/or

V) was developed by the Purchaser independently and without access to or reference to our confidential information.

RESIGNATION

12.1. If MPG is in default of delivery due to gross negligence on its part, the Purchaser may declare its cancellation by registered letter to MPG after setting a reasonable grace period of at least 30 days in writing. The right of cancellation shall only apply to the part of the delivery in respect of which there is a delay. In the event of cancellation, the Purchaser is obliged to return the goods to MPG at his own expense.

12.2. MPG may withdraw from the contract if, after conclusion of the contract, events occur which make it impossible or impossible at all to fulfil the contract on the agreed terms, or if delivery is impossible for reasons for which the Purchaser is responsible or is further delayed even after MPG has set a reasonable grace period.

12.3. MPG reserves the right to assert claims for damages.

IMAGE RIGHTS

All image rights are held by us or our partners. The use of images, even in part, is not permitted without our express consent.

COMMUNICATIONS

The Purchaser agrees to receive various notifications and documents by e-mail. This includes in particular the receipt of order confirmations, order confirmations, dispatch confirmations and the like.

DATA PROTECTION

All personal data is only collected, stored and/or processed in compliance with the relevant provisions of the applicable data protection law. The details are contained in the privacy policy, which is made available separately on our website https://mpg-eyewear.com/datenschutz/. The rights and obligations arising from our cooperation with regard to data processing are - where legally required - agreed in a separate commissioned data processing agreement.

ADVERTISING MATERIAL

16.1. If the Purchaser is provided with advertising material, the terms of use communicated to the Purchaser, in particular with regard to the spatial, temporal and content-related provisions, must be complied with as part of the contract. The Purchaser is not authorised to pass on the advertising material to third parties for their use. We reserve the right to reclaim the advertising material provided at any time. The use of our brands, images or illustrations of our products in advertising material must be agreed with us in writing in advance.

16.2. MPG prepares its catalogues, other sales documents, lists and drawings as well as dimensional data with all due care, but reserves the right to correct obvious errors at a later date.

EUROPEAN MEDICAL DEVICE REGULATION

The obligations and responsibilities arising from the European Medical Device Regulation No. 2017/745 between the industry as MANUFACTURER and the DISTRIBUTOR as optician are regulated in a separate quality assurance agreement to ensure the conformity and quality of ophthalmic optics products throughout the supply chain.

QUALITY ASSURANCE AGREEMENT

18.1. This Quality Assurance Agreement (hereinafter referred to as "QAA") is concluded by the parties for the entire term of the business relationship between the MANUFACTURER and the DISTRIBUTOR and thus applies to all orders and purchases of medical devices by the MANUFACTURER. Both PARTIES therefore declare this QAA to be binding for the duration of their business relationship and beyond that for the fulfilment of their regulatory obligations under medical device law. The QAA has the same term as the underlying agreements under commercial law or as long as the business relationship between the MANUFACTURER and the DISTRIBUTOR exists and orders or product purchases are made by the DISTRIBUTOR from the MANUFACTURER.

18.2. Purpose & goal

This QAA regulates the regulatory obligations and responsibilities between the industry as MANUFACTURER and the ophthalmic optics company in its function as DISTRIBUTOR under medical device law. This creates an important prerequisite for economic and quality-assured co-operation between the PARTIES.

The QAA is based on the relevant requirements of the relevant legislation and medical device standards. The requirements of the European Medical Device Regulation No. 2017/745, also referred to as the "Medical Device Regulation" (hereinafter "EU-MDR"), must be taken into account by both PARTIES.

The QAA is intended to ensure that the MANUFACTURER and the DISTRIBUTOR are aware of the obligations and responsibilities arising from the EU-MDR and fulfil these in mutual cooperation. This is intended to ensure the conformity and quality of the ophthalmic products throughout the entire supply chain.

The ophthalmic optical products supplied by the MANUFACTURER are used to correct defective vision and to compensate for functional deficits of the eyes. In doing so, the MANUFACTURER complies with the necessary regulatory requirements of Regulation (EU) 2017/745 MDR and applicable harmonised standards.

18.3. Scope of application

The subject of this QAA are all medical devices that the DISTRIBUTOR receives from the MANUFACTURER for the provision on the market. This QAA also includes all services and performances (e.g. customisation) that are required by the DISTRIBUTOR in connection with the provision of the aforementioned medical devices on the market.

Both CONTRACTING PARTIES understand "making available on the market" to mean any supply of a device for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge, with the exception of investigational devices for clinical trials (Article 2(27) of EU-MDR).

Even after termination of the contractual relationship, the retention periods and information obligations specified in the EU-MDR continue to apply.

If the DISTRIBUTOR ends its business activities by selling the company, the contractual relationship established by the QAA shall end without any further declaration of intent. The DISTRIBUTOR shall ensure that the subsequent obligations arising from the EU-MDR are assumed by the purchaser of its company.

18.4. Content of the QAA

18.4.1.Receiving inspection, rejections

The MANUFACTURER shall deliver the products in suitable packaging selected by him, which prevents transport damage when properly transported by a transport service provider, unless the packaging is otherwise defined in consultation with the MANUFACTURER. The packaging must comply with the applicable statutory disposal regulations of the country of manufacture.

The MANUFACTURER shall enclose the necessary information with each delivery to enable the DISTRIBUTOR to identify the goods, allocate them to the order and check for transport damage. This includes at least one delivery note with order number, article number (if available) and quantity details.

18.4.2.Declarations of conformity

Before the DISTRIBUTOR makes the medical devices purchased from the MANUFACTURER available on the market, the DISTRIBUTOR shall verify that all of the following requirements are met:

The medical device or its packaging bears the CE mark.
The MANUFACTURER has issued an EU Declaration of Conformity for the medical device and keeps it available for inspection.
The medical device is identifiable and the MANUFACTURER may have assigned a UDI for the medical device.

To verify these requirements, the DISTRIBUTOR may use a sampling procedure that is representative of the medical devices supplied to him by the MANUFACTURER.

18.4.3.Documentation, archiving

The manufacturer prepares the technical documentation in accordance with EU-MDR requirements and all other regulatory required documents. The manufacturer shall keep the entire documentation available for inspectionby the authorities for at least ten years after the last product covered by the EU declaration of conformity was placed on the market.

The MANUFACTURER shall provide the DISTRIBUTOR with the following documents:

the EU Declaration of Conformity (on request)
the information relevant to spectacle lenses / frames in accordance with Annex I Section 23 of the EU-MDR. Product catalogues, product information, the website and packaging shall contain the necessary information for each product to enable identification of the product and the manufacturer, as well as all information relevant to the user or, where applicable, third parties, on the safety and performance of the product and any restrictions on use, precautions or warnings.

The DISTRIBUTOR documents

the written regulation,
the adjustment dates, insofar as these are not part of the written regulation,
the information required to identify the patient,
the information required to identify the customised product,
the declaration that the product has been adapted to the current state of the art.

The DISTRIBUTOR shall keep the documentation for ten years and submit it to the competent authority upon request.

In order to support the DISTRIBUTOR in his obligation to keep a register of complaints, non-compliant products and recalls and withdrawals (Article 14(5) of EU-MDR), this register is kept by the MANUFACTURER.

To this end, the DISTRIBUTOR shall forward complaints and reports from patients or users about suspected incidents in connection with a product that it has provided to the MANUFACTURER without delay and shall make all information available to the MANUFACTURER on request.

18.4.4.Labelling and traceability

The MANUFACTURER shall provide the following information on the labelling (according to MDR Annex I Section 23.2. applicable points for spectacle lenses and spectacle frames)

The name, type designation or trade name of the product.
All absolutely necessary information from which the user can see what the product is.

For spectacle lenses, this is all the information according to DIN EN ISO 14889 point 6, which must be stated on the lens bag.

Indication that the lens is a right or left lens, if applicable
Refractive power and near addition effect in dioptres (sph, cyl, axis, add, prism, base)
Prismatic effect of the additional partial prism for multifocal lenses, if available
Position of the distance reference point for aspheric multifocal lenses
Nominal size in millimetres
Dimensions of the additional part for multifocal lenses in millimetres
Colour, if applicable
Designation of the coating
Trade name of the material or/and the refractive index
Target peak refractive index (=measured values) where applicable
Method for measuring the seam allowance, if not the method using the surface on which the seam allowance is located

For spectacle frames, this is all the information according to DIN EN ISO 12870 point 9, which must be stated on the frame.

Model designation
Colour specification
Disc length with box symbol
Distance between the lenses
Total bow length

The name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business.
The lot number or serial number of the product
The date of manufacture
An indication on the packaging that the product is a medical device
The CE mark
The UDI from 26 May 2025 at the latest

The symbols according to DIN EN ISO 15223-1 (Medical devices - Symbols to be used on medical device labels, labelling and information to be provided) can be used for this purpose:

Manufacturer
Authorised representative in the EU
Importer
Distributor
Date of manufacture
Medical Device
Lot Number
Catalogue Number
Serial Number
Unique Device Identifier

The DISTRIBUTOR checks whether the labelling is complete.

The MANUFACTURER guarantees traceability via the batch number / serial number / order number and, as soon as available, via the UDI.

18.4.5.Storage, packaging and onward transport

Apart from protection against mechanical damage, there are no special storage and transport conditions for spectacle lenses and frames. They should be stored in a closed, dry and, if necessary, temperature-controlled room or transported in suitable packaging.

18.4.6.Delivery of the products to the end consumer.

The DISTRIBUTOR shall instruct the end consumer in the proper use of the spectacles, including correct care and handling.

The DISTRIBUTOR shall inform the end consumer of any restrictions on use and risks. These include in particular

Restrictions on driving a motor vehicle
the information that spectacle lenses are generally not unbreakable

The MANUFACTURER provides the DISTRIBUTOR with all the necessary information (fitting instructions, instructions for use, restrictions on use, warnings, etc.) in its product catalogues (sales price list, product information). This enables the DISTRIBUTOR to inform the end consumerof any restrictions on use and risks before the spectacles are ordered.

When delivering the customised product, the DISTRIBUTOR shall provide the end consumer with a declaration containing the following information:

the written regulation,
the adjustment dates, insofar as these are not already part of the written regulation,
the information required to identify the customised product, and
the declaration that the product has been adapted to the current state of the art (valid national or international standards generally reflect the state of the art)

Note 1:

By way of exception, instructions for use are not required for class I and IIa medical devices if safe use of these devices is guaranteed without instructions for use.

As the spectacles are supplied to the end consumer by specialised circles (opticians) and the end consumer is informed about the correct use, restrictions on use and risks, the safe use of the product is guaranteed even without instructions for use. Lenses and frames are therefore supplied by the MANUFACTURER without instructions for use.

Note 2:

Any subsequent processing of a spectacle lens by the optician (tinting, lacquer hard sealing, anti-reflective coating, ...) that goes beyond the frame-appropriate lens edge is carried out under the optician's own responsibility and excludes any liability on the part of the manufacturer.

18.4.7.Complaints (incidents)

If the DISTRIBUTOR receives information from the market that a medical device placed on the market by him is the subject of a complaint, he shall inform the MANUFACTURER immediately so that the latter can initiate any necessary corrective measures. The DISTRIBUTOR shall provide the MANUFACTURER with all necessary information about the product and the end user from its customer register.

18.4.8.Serious incidents and recall

The DISTRIBUTOR shall notify the MANUFACTURER without undue delay if the DISTRIBUTOR considers or has reason to believe that a medical device of the MANUFACTURER made available by them on the market does not comply with EU-MDR 2017/745 and/or poses a serious risk.

(According to EU-MDR 2017/745, the DISTRIBUTOR is obliged to forward all complaints and reports from healthcare professionals, patients or users about serious incidents in connection with the medical devices purchased from the MANUFACTURER to the MANUFACTURER without delay).

The DISTRIBUTOR shall co-operate with the MANUFACTURER and the competent authorities to ensure that, where necessary, corrective action is taken to bring the product into conformity, withdraw it from the market or recall it.

The DISTRIBUTOR undertakes to provide the competent authority, upon request, with all information and documents available to the DISTRIBUTOR that are necessary to demonstrate the conformity of the medical device purchased from the MANUFACTURER.

The DISTRIBUTOR shall immediately inform the MANUFACTURER of the competent authority's request. The MANUFACTURER shall co-operate closely with the DISTRIBUTOR in order to process the request of the competent authority as quickly as possible. Relevant or requested information can then be provided directly by the MANUFACTURER to the competent authority.

The DISTRIBUTOR shall co-operate with the competent authorities, at their request, on any action taken to eliminate the risks posed by the products purchased from the MANUFACTURER and made available on the market. Upon request, the DISTRIBUTOR shall provide a competent authority with samples of the product free of charge or, where this is not practicable, grant it access to the product.

(According to the EU-MDR, the DISTRIBUTOR is obliged to inform the competent authority, the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen - BASG), in the event of a serious risk. The MANUFACTURER undertakes to support the DISTRIBUTOR in this case and to provide decisive assistance in communicating the exact details of the non-compliance and corrective measures already taken).

At the request of the competent authority, the DISTRIBUTOR may hand over all information and documents to the MANUFACTURER after consultation with the latter, provided that the information and documents available to the DISTRIBUTOR are necessary to demonstrate the conformity of a medical device purchased from the MANUFACTURER. The MANUFACTURER and the DISTRIBUTOR shall co-operate closely. Uponrequest, the MANUFACTURER shall provide the necessary information to the DISTRIBUTOR or the competent authority. The DISTRIBUTOR undertakes to inform the MANUFACTURER immediately of the information and documents provided to the competent authority.

APPLICABLE LAW AND JURISDICTION

19.1. The law of the Republic of Austria shall apply to these Terms and Conditions and the entire legal relationship between the Purchaser and us, to the exclusion of the conflict of law provisions of other legal systems and to the exclusion of the UN Convention on Contracts for the International Sale of Goods.

19.2. The place of jurisdiction for all disputes arising directly or indirectly from the contractual relationship, in particular for delivery and payment, shall be the competent court in Graz. We shall also be entitled to assert claims at the Purchaser's place of jurisdiction.

INVALIDITY OF CLAUSES

Should any provision of these Terms and Conditions be or become legally invalid or unenforceable in whole or in part, this shall not affect the legal validity of all other provisions of the contract.

The contracting parties shall replace the legally invalid or unenforceable provision with a valid and enforceable provision that comes as close as possible to the content and purpose of the legally invalid or unenforceable provision.

(Status: March 2025)