1. Scope of application and purpose
The company TEKNIMED, develops, manufactures and commercializes medical devices (“Products”) and is declared as such with the French National Agency for the Safety of Medicines (ANSM). These general terms and conditions of sale (“T&C’s”) apply to any commercial offer, sale or Product order agreed between TEKNIMED (the “Supplier”) and any health professional (hereinafter the “Client”). They form the basis of the commercial negotiation within the meaning of article L.441 – 6 of the French Commercial Code. These T&C’s supersede any previous T&C’s. The agreements signed and orders placed with TEKNIMED are subject to these general terms and conditions, which are liable to be supplemented by special conditions in accordance with current regulations. The act of placing an order implies the full and unqualified acceptance by the Client of these T&C’S.
No special condition may prevail over these T&C’S unless formally accepted in writing by TEKNIMED. These general terms and conditions as well as the special conditions accepted by both parties are an integral part of the agreement. The following documents are not part of the agreement: sales documents, catalogues, adverts, prices which are not expressly mentioned in the special conditions which constitute purely indicative and non-binding information.
2. Offer, price and acceptance
The Supplier’s quote is valid for the entire period indicated or, by default, within thirty (30) days following the date of issuance. The prices are valid for packaged Products, in euros, exclusive of VAT. Customs, transportation, and insurance fees are under the Incoterm ” Ex-Works – ZONE INDUSTRIELLE LA HERRAY – 65500 VIC-EN-BIGORRE” FRANCE. They are invoiced in accordance with the terms of the agreement.
Any amendment to the range of Products or to the Products price list shall be provided to the Client within thirty (30) days prior to its implementation. Unless a fixed price was agreed beforehand, any Product delivered is invoiced at the price stated in the price list on the day of the order. Any changes, in particular the removal of articles, may under no circumstances lead to forced deliveries, nor to claims for damages and interest.
The agreement is only completed subject to the Supplier express acceptance of the order by any written means. An intent to order shall not be treated as an order. All orders must follow the Supplier’s order guidelines.
3. Modification, suspension and cancellation of order
Any modification or suspension of the order requested by the Client is subject to the express acceptance of the Supplier and is made official by a written agreement, which shall consider the resulting extra costs and lead times. No previously placed order may be cancelled by the Client. Otherwise, the Supplier shall be entitled to ask for the agreement execution and the amounts stipulated therein to be paid in full.
4.1. The delivery is deemed to be made “Ex-Works – ZONE INDUSTRIELLE LA HERRAY – 65500 VIC-EN-BIGORRE”, in accordance with the latest INCOTERMS edition. The Product are shipped from the Supplier’s warehouses at the risk of the Client.
4.2. Delivery times are purely indicative and are not guaranteed. In any event, deliveries may only be made on time if the Client is up-to-date in respect of all of its obligations or local importation authorities towards the Supplier.
Delivery delays shall not result in the cancellation or amendment of the agreement, and may not give rise to the award of damages. Should any of the Products ordered, be out of stock, the Supplier shall warn the Client as soon as possible with a view to providing it with an indicative expecting shipping date.
4.3. It is up to the Client to check the Products upon delivery. In the event of Product damage or non-conformity with respect to what is indicated on the delivery note, the Client shall (i) express objections on the delivery note and immediately inform in writing the Supplier and (ii) inform the carrier of unsatisfactory delivery in the manner and timescale required by Article L.133-3 of the French Commercial Code, as well as inform the Supplier at the same time.
4.4. Upon receipt of the Products, the Client is responsible for ensuring that the delivery is in conformity with its order and that there are no visible defects.
Any claim regarding visible defects or non-conformity of the delivery shall be made in writing by registered letter with acknowledgement of receipt within a maximum of forty-eight (48) hours as of the delivery of the Products. Such a claim shall be duly justified in order to allow the Supplier to assess the reality of the claim. Failing that, the delivery shall be considered as fully compliant with the order, both in terms of quality and quantity. No complaint shall be considered by the Supplier once the Products has been used except regarding materiovigilance procedure with the competent authorities.
In the event of a visible defect or non-compliance, the Client may only be able to have the Products replaced. No refund in respect of any other cost and/or compensation of any kind whatsoever shall be payable. The costs incurred when any new Products are taken back or delivered are the sole responsibility of the Supplier.
4.5. In the event of penalties having been agreed by the parties, they shall have a compensatory value which is fixed, payable in full and exclusive of any other penalty or compensation. These contractual penalties shall be capped and only apply to the part of the concerned Products.
4.6. If the Products have to be exported from France, it is the Client’s responsibility to comply with any laws or regulations governing the importation of Products into the country of destination and the payment of related taxes.
5. Products returns
No return may be carried out and accepted without the prior agreement of the Supplier irrespective of the reason. As appropriate, the Products are returned in the state in which they were delivered and at the cost and risk of the Client. No return shall be accepted if such request is received by the Supplier after a period of fifteen (15) days following the date of receipt of the Products by the Client.
6.1. The IFU shall be delivered by Supplier in English, French, Spanish and German with the Products. The other EU IFU languages will be available in e-IFU version under the new Medical Device Regulation (EU) 2017/745 and with the products during the transition period. Distributor will inform Supplier where the Products will be sold and Supplier will make the translation at Distributor’s charge for the e-IFU website. For any and all specific language requirements needed for countries, all expenses and labelling modifications will be at Distributor’s charge.
In addition to the above, Supplier will provide Distributor, according to reasonable needs, with commercial literature or brochures in English, and all other data that could help the promotion of the Products. All documents over a certain weight or value, or documents required in large quantities or in another language, will be at the charge of Distributor and validated by Supplier, provided that they are compliant with the applicable laws, including but not limited to the laws of the Territory.
6.2. The Products comply with the general safety and performance requirements applicable at the date of manufacture of the Products, and in particular the requirements of ISO 13485 Quality management systems and of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, and repealing Council Directives 93/42/EEC, as well as 93/42/EEC during the transition period.
6.3. The Client is responsible for the choice of product depending on the use that it has planned for it and in accordance with its technical needs. The Client is responsible for using it in a manner that would normally be expected and in accordance with current legislation and professional standards of its sector. In cases where the Client resells Products, the Client represents and warrants that such resale is in full compliance with applicable regional medical device regulations.
6.4. In accordance with the French legal and regulatory requirements in force applicable to its status, the Client acts, in the course of its activities, with the due diligence required to comply with the applicable requirements. More specifically, the Client when it acts as Supplier’s distributor, undertakes to:
sell the Product(s) without any change in its original packaging, in accordance with the instructions set out in the IFU, label and quality requirements of Supplier,
achieve an appropriate level of traceability of the Products and that records are available upon request,
maintain product compliance regarding distribution of medical devices provided by the Supplier,
protect medical devices provided by the Supplier against any damage, alterations or contamination when medical devices are exposed to the conditions defined and planned by the Supplier and to additional hazards during distribution. If specific conditions have to be respected, they have to be controlled and/or registered. Any excursions in temperature or humidity outside the label storage range will be investigated by the party incurring the excursion and immediately notified to the Supplier in case of impact that can affect performance and/or safety of the Products,
promptly inform Supplier in accordance with local regulation if it becomes aware of any actual or potential problems relating to the quality or performance of Product, any Product non-compliance or any complaint due to the sale or use of the Products,
inform Supplier of any undesirable events as soon as it becomes aware of it and immediately inform the competent authorities when it considers or has reason to believe that a Product presents a serious risk as recited in the general quality and regulatory conditions,
recall the Products according to the requirements of Supplier as recited in in the general quality and regulatory conditions,
return nonconforming Products to Supplier for investigation and analysis,
comply with the storage and transport conditions defined by Supplier,
cooperate with the competent authorities during announced audits and, if necessary, unannounced inspections,
maintain a record of complaints, non-compliant Products, recalls, and communicate this follow-up or any other related information upon request by Supplier. Upon review of the investigation report, Supplier reserves its right to require additional information as necessary and Distributor undertakes to cooperate with Supplier in addressing any further requests for information concerning a complaint,
on Supplier’s request, to support Supplier and put in contact with local surgeons for clinical studies which could be required by authorities and post market follow up regulatory obligations,
inform Supplier about local requirements or specific registration updates within the Territory.
play a real intermediary role between Supplier and the end user (surgeon) for information related to the Product.
6.5. The Supplier reserves the right to conduct announced audits at Distributor’s premises to verify the conditions of transport, storage and handling of the Products and to verify the integrity and traceability of the Products until they are received by the end users.
6.6. The Client undertakes to keep all documents provided by the Supplier and/or in connection with the Products and to keep them at the disposal of the competent authorities for a period of fifteen (15) years.
7.1. The Products sold are covered by the legal guarantee concerning hidden defects, within the meaning of article 1641 of the French Civil Code. The apparent defects that the Client may have observed at the time of delivery of the Product are not considered as hidden defects.
7.2. Supplier provides a three (3) month guarantee as of the delivery date of the Products. The guarantee covers any manufacturing or material defect in accordance with the registration certificate, which may be included with the Products. In order to invoke the guarantee, Distributor shall immediately and no later than eight (8) days from the discovery of the defect, inform Supplier in writing about the defects that it attributes to the Product and shall provide details about how it was used when those defects became apparent.
The guarantee involves, at the option of Supplier and to the extent permitted by the applicable law, either replacing or repairing the Product which has been recognized by Supplier as being faulty. Unless specifically agreed otherwise by the Parties, transportation and shipping costs shall be at Distributor’s risk and costs.
7.3. The guarantee shall not apply, and Supplier is not held liable in any of the following cases:
installation or use which is non-compliant with professional standards, or the established technical specifications,
non-compliance with the instructions of use,
lack of supervision, transportation, storage or maintenance,
modification to or work carried out by Distributor or a third party on the Products and which was not authorised by Supplier and/or using non-original parts or consumables.
The guarantee shall not apply and Supplier shall not be held liable, in the event of the Client not-paying and it may not invoke the guarantee in order to suspend or defer outstanding payments.
8. Payment terms
8.1. The terms and conditions of payment are as follows:
Payment is made in euros and by bank transfer,
For all new clients or Pro-forma clients, payment must be made prior to shipping. After a minimum of 3 orders, payment terms could be granted only if the Supplier’s credit underwriter gives its approval and without exceeding the maximum credit allowed.
The maximum payment term is 30 days from the date on which the invoice was issued,
Bills of exchange are only considered as payments once they have actually been cashed.
The contractually agreed payment dates may not be challenged unilaterally by the Client under any reason whatsoever, including in the event of a dispute.
8.2. In accordance with article L. 441-10 of the French Commercial Code, in the event of late or non-payment, the Client shall as of rights be liable and this, without prejudice to any claims for damages and interest:
For late payment penalties calculated based on a rate equal to the most recent refinancing rate of the European Central Bank plus ten percentage points, applied to the entire amounts due or remaining due. Late penalties are due on the day following the settlement date on the invoice without the need of a reminder,
for flat-rate compensation for recovery costs of which the amount is set by decree at 40 euros.
Any late payment of an instalment may result in, at the Supplier’s discretion, the expiry of the contractual payment term, and all of the amounts owed becoming immediately payable.
The Supplier invoking any of these provisions does not deprive it of the option of implementing the retention of title clause stipulated under Article 9.
8.4. The Client formally undertakes not to engage in any practice consisting of automatically debiting or invoicing the Supplier for sums which were not expressly recognized by it in writing.
8.5. In the event of a deterioration of the Client’s financial situation recorded by any means and/or demonstrated by a significant delay in payment or repeated delays or should the financial situation differ significantly from the data provided, the Supplier reserves the right to demand additional guarantees, to require immediate payment in return for the delivery of the pending orders, and to suspend any order or refuse any new order.
9. Retention of title
Supplier retains full ownership of the Products until the effective and full payment of the principal of the Products and incidental costs.
Once the Products have been made available or delivered at an agreed place, Distributor becomes liable for any damage that these Products may suffer or which may be caused to them.
Distributor undertakes not to pledge or transfer as warranty the ownership of the Products until the price has been paid in full.
The Products must be easily identifiable as the property of Supplier and Distributor undertakes to make known the right of ownership of Supplier in the event of a seizure or a claim from a third party. Products in stock will be presumed to be unpaid.
Failure to pay any of the instalments on the due date, Supplier may invoke its right of ownership if after 8 (eight) days of Distributor having received a registered letter with acknowledgement of receipt, the formal demand contained therein has remained unanswered. In this case, the Products shall be returned to Supplier, at Distributor’s costs and risks, without prejudice to the exercise of any other right of Supplier.
If the Products are returned in a non-conform state, Supplier will charge Distributor at cost of sales and destroy the Products.
Distributor shall take out, at its own expense, comprehensive insurance covering the risks which may arise from the delivery of the Products, and include Supplier as a beneficiary of said insurance.
10. Hardship and force majeure
10.1. If an event that is beyond the Parties’ control compromises the equilibrium of the agreement to such an extent that one of the Parties is unable to execute its obligations, the Parties agree to negotiate in good faith a modification to the agreement. Such events include particularly the occurrence of a fluctuation in the price of raw materials, a change in customs duties, a change in the exchange rate or in the applicable laws and regulations.
10.2. Neither party in this agreement shall be held liable for its delay or failure to execute its obligations hereunder if such delay or failure is the direct or indirect consequence of an event of force majeure which shall mean and include any occurrence or event beyond the reasonable control of either party, in consequence of which such party cannot execute its obligations as set out in this agreement. For purposes of this Clause, force majeure shall include the occurrence of a natural disaster, earthquakes, storms, fires, floods, conflicts, wars, attacks, labour conflicts, total or partial strikes at the premises of Supplier, Distributor, or Supplier’s subcontractors, providers of services, carriers, post, public services, etc, mandatory orders of the public authorities (import prohibitions, embargos), operating accidents, freight embargo machine breakdowns, explosions. Each party shall immediately inform the other party of the occurrence of an event of force majeure brought to its knowledge which, in its opinion, is of such a nature as to affect this agreement.
The parties shall consult with each other within the shortest possible time to examine, in good faith, the consequences of the event of force majeure, and mutually consider the measures to be taken.
11. Intellectual property and confidentiality
11.1. The Supplier is the owner of all intellectual and industrial property rights relating to the Supplier’s Products and brands. Intellectual property rights, as well as the know-how incorporated in the documents transmitted, the Products delivered remain the sole property of the Supplier. Any transfer of intellectual property rights or know-how shall be the subject of a specific agreement.
The Supplier reserves all intellectual property rights that may arise from the results of its research and development work, including when these are taken over, in whole or in part by the Client.
11.2. Each party guarantees that the items that is has provided or designed for the performance of the agreement do not make use of the intellectual property or know-how rights owned by a third party (plans, specifications, processes, and their implementation conditions, etc.). They guarantee each other against the direct or indirect consequences of any civil or criminal liability action resulting in particular from an act of infringement or unfair competition.
11.3. The parties mutually undertake a general obligation of confidentiality relating to any confidential information, oral or written, whatever it may be and whatever the medium exchanged in the course of the preparation and performance of the agreement, including the information included in Article 11.1, personal data, confidential information of a commercial nature and business secrets, inspections, investigations and audits, except information which is generally known to the public or which will become known to the public otherwise than through the fault or fault of the Client (“the Confidential Information”).
The parties undertake not to use all or part of the Confidential Information for any purpose or activity other than the performance of the agreement and not to copy or imitate all or part of the Confidential Information.
The parties undertake to take all the necessary measures to ensure the compliance with this obligation of confidentiality, for the entire term of the agreement and for five (5) years as of its expiry, and guarantee that all of their employees and sub-contractors or other contractor shall meet this obligation.
The parties may, however, be required to disclose Confidential Information if the law or a legal institution (judge, authority) requires them to do so. In this case, the party concerned shall inform the other party beforehand.
12.1. The Products are in compliance with applicable regulations. As the legal manufacturer, Supplier is fully responsible for the Products in quality requirements. The Supplier’s liability, all causes combined, with the exception of bodily injury and gross negligence, or any other cause for which the Supplier cannot, under the terms of the legislation in force, exclude or attempt to exclude its liability, is limited to an amount capped at the amount of the order. The Supplier shall not be required to compensate, to the extent permitted by applicable law, for immaterial or indirect damages (such as: loss of business, profit, opportunity, commercial loss, loss of profit) or the harmful consequences of faults committed by the Client or third parties in connection with the performance of the agreement. The Client guarantees the Supplier or Supplier’s insurers against recourse taken by Client’s insurers or third parties in contractual relationships therewith, above the limits and exclusions specified above.
12.2. The Supplier cannot be held liable in the event of non-compliance with the legislation of the country, outside France, where the Products are distributed by the Client. It is the Client’s responsibility to check with the local authorities the possibilities of importing or using the Products that it intends to order and to ensure that it has all the necessary authorisations relating thereto. The Client shall keep the Supplier informed of the countries in which the Products are distributed and provide proof of registration in those countries.
12.3. Supplier may decide to stop the continuity of a CE marking or a local registration and the discontinuation of the Product without the Client being able to claim any damages related to its commitment towards third parties. If the Client have made the registration for the Supplier and decide to stop the distribution, he will transfer free of charge the registration to Supplier.
12.4. In the event of non-performance of all or part of its obligations by the Client, the agreement may be automatically terminated by the Supplier after sending a letter of formal notice sent by registered letter with acknowledgement of receipt which has remained without effect for thirty (30) days.
12.5. The Supplier and the Client are required, at the request of the other party, to present their current insurance certificate covering their civil liability and indicating the duration, nature and amount of the coverage.
13. Personal data
The Client may transmit data, including personal data, to Supplier which shall be used for the executing the agreement, the processing of requests or orders. Supplier shall collect and process personal data in accordance with applicable laws and regulations and in particular the General Data Protection Regulation (EU) 2016/679 (GDPR). Personal data may be collected and processed in the context of exchanged emails, the conclusion of contractual documents, the transmission of documents, as well as any other exchange between the Client and Supplier, which the Client accepts. This may include the following data:
contact details and information of the Client or one of its employees (name, e-mail address, telephone number, address, legal information of the company, bank details, etc.),
information on the Client’s situation (in particular economic situation).
This personal data shall only be used for the sole purpose of executing the agreement and processing the Client’s orders. They will not be passed on to a third party.
Supplier undertakes to take all necessary measures, in particular technical and logistical measures, to ensure the conservation, protection and security of the personal data collected. These data shall be kept at least for the duration of the commercial relationship and up to 15 years after the end of the collaboration.
For all personal data transmitted to Supplier, the Client has a right of access, a right of rectification and modification, a right of opposition, a right of portability and limitation of processing as well as the choice of the fate of the same data after death. Distributor may exercise these rights by contacting Supplier at the following contact address: “firstname.lastname@example.org”
In accordance with its legal obligations, Distributor shall perform within a maximum period of one (1) month from receipt of the request. Failing this, Distributor has the possibility of submitting a complaint to the French competent supervisory authority, the CNIL, online or by post.
14. Applicable law and jurisdiction
The applicable law is French law.
The Parties shall attempt to settle their disagreements amicably before applying to the competent Court.
In the absence of an amicable agreement, any dispute relating to the agreement shall be brought before the High Courts in the Jurisdiction of the Court of Appeal of Toulouse, even in the event of summary proceedings and multiple defendants.
Taking into account the European general safety and performance requirements relating to medical devices, in accordance with the French legal and regulatory requirements in force applicable to its status, Distributor, in the course of its activities in the European Union and with the due diligence required, shall be aware and comply with the applicable requirements and in particular Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, and repealing Council Directives 93/42/EEC, as well as 93/42/EEC during the transition period.
For registration of the Products outside of the European Union, the Distributor, in the course of its activities and with the due diligence required, shall be aware and comply with the specific on-going requirements in the country where applicable.
Distributor shall keep Supplier informed of the countries in which the Products are distributed (or will be subsequently) and provide proof of registration in those countries.
Supplier and Distributor are required, at the request of the other party, to present their current insurance certificate covering their civil liability and indicating the duration, nature and amount of the coverage.
This quality and regulatory conditions define the obligations and responsibilities in connection with the Products manufactured by Supplier.
– CE marking of conformity or CE marking: marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.
– Incident: any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.
– Implantable device: any device, including those that are partially or wholly absorbed, which is intended to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure and any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days.
– UDI: a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.
– Recall: any measure aimed at achieving the return of a device that has already been made available to the end user.
– E-IFU: electronic Instructions for use.
1. Product requirements
1.1 Laws applicable to the Products
The Products manufactured by Supplier within the framework of this Agreement shall be supplied to Distributor with the CE mark pursuant to the European regulations in force. The Supplier shall provide to the Distributor the CE certificate and/or the declaration of conformity related to the Products.
The Products manufactured by Supplier within the framework of quality assurance system follow the general standards in force ISO 13485 Quality management system, MDSAP requirements and pursuant to European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, and 93/42/EEC, as well as 93/42/EEC during the transition period. Other regulations may be applicable depending to the countries of distribution.
1.3 Packaging, labelling and sterilisation
The Products are packaged and sterilised by the Supplier in accordance with all the applicable regulations and standards and its quality system requirements. Supplier shall comply with all the applicable regulations of the European Union and standards for the packaging and labelling of the Products, including the assignment of a UDI.
In particularly, for implantable devices except for sutures, an implant card will be provided together with the device under the Regulation (EU) 2017/745, and patient leaflet information will be on a website: www.myimplantcard.com.
On all the product packaging, Supplier shall be identified as the legal Manufacturer pursuant to Essential Requirement No. 23 of Appendix I of European Parliament and of the Council of 5 April 2017 on medical devices, and 93/42/EEC.
The IFU shall be delivered by Supplier in English, French, Spanish and German with the Products. The other EU IFU languages will be available in e-IFU version under the new Medical Device Regulation (EU) 2017/745 and with the products during the transition period. Distributor will inform Supplier where the Products will be sold and Supplier will make the translation at Distributor’s charge for the e-IFU website.
For any and all specific language requirements needed for countries, all expenses and labelling modifications will be at Distributor’s charge.
Both parties (Supplier and Distributor) shall rely on their respective quality systems to guarantee that the manufacturing and distribution operations are carried out properly, as defined in the procedures of both parties. The Distributor agrees to provide quality procedures or defined processes upon request from the Supplier.
The Parties shall keep each other mutually informed of any change in their quality system and in the certification status of the Products (upgrade, renewal or withdrawal of the EC certificates).
Distributor shall establish and maintain processes for incoming inspection of medical devices provided by the Supplier. In case of a detection of nonconforming products, Distributor shall inform the Supplier and address the identification, documentation, evaluation, segregation, and disposition of Nonconforming Product.
Distributor is an independent intermediary which has sufficient means and resources to ensure an autonomous and independent distribution of the products, in the territory.
In particular, but without limitation, Distributor,
‐ warrants that he is legally qualified within the Territory to market, distribute and sell the Products,
‐ is registered as a distributor in the national database where applicable and maintain up to date such information,
‐ shall ensure that it complies with the laws of the Territory relating to the distribution and sale of the Products,
‐ is responsible for any local requirements or specific registration within the Territory,
‐ shall comply with all applicable existing and future laws, regulations and acts in force in the Territory,
‐ shall inform Supplier for any updated regulation within the Territory.
Any change in Distributor’s registration or certification status or observations by the applicable Authority or Notified Body indicating a possible withdrawal of registration or certification must be communicated to Supplier within ten (10) Business Days. Notwithstanding the foregoing, if any certification is suspended, expired, put on probation, or placed on any other special status, Distributor shall notify Supplier within five (5) Business Days.
Distributor who is experienced in the distribution of biomaterials and has suitable facilities for selling such products, is willing to distribute some of Supplier’s products that it has selected.
Distributor shall maintain product compliance regarding distribution of medical devices provided by the Supplier.
Distributor is responsible for the choice of Product depending on the use that it has planned for it and in accordance with its technical needs. Distributor shall have systems in place to control shipment of Products so that only Products compliant (no non-conformity declared or found at Distributor place) are shipped. Distributor shall ensure that no rejected, expired, or deteriorated Products are shipped.
Distributor represents and warrants that such resale is in full compliance with applicable medical device regulations, current legislation and professional standards of its sector in the Territory.
Distributor is responsible for management of Distributor’s Sub-distributor based upon risk as determined per Distributor’s own internal processes. Distributor must ensure that all requirements set in this agreement are respected. Supplier reserves the right to audit Distributor’s Sub-distributor under similar circumstances. Distributor shall cooperate with and support such audits and shall use reasonable efforts to maintain contractual rights to such audits.
Distributor shall protect medical devices provided by the Supplier against any damage, alterations or contamination when medical devices are exposed to the conditions defined and planned by the Supplier and to additional hazards during distribution. If specific conditions have to be respected, they have to be controlled and/or registered. Any excursions in temperature or humidity outside the label storage range will be investigated by the party incurring the excursion and immediately notified to the Supplier in case of impact that can affect performance and/or safety of the Products.
Distributor shall inform Supplier of any change of location or name for the distribution and/or storage site for the Products provided by Supplier.
Distributor shall implement all the promotional methods necessary for the sale and the publicity of the Products (advertising, trade fair, exhibitions, medical congress etc.) in accordance with the local regulations. Any and all financial participation on the part of Supplier shall be subject to a prior written letter of consent from the latter.
Distributor shall provide, at its own expenses, its clients with a copy of the technical documentation in force at the date of sale to the client, and clearly explain to them the appropriate method of Product use.
On Supplier’s request, Distributor shall support Supplier and put in contact with local surgeons for clinical studies which could be required by authorities and post market follow up regulatory obligations.
Distributor undertakes to play a real intermediary role between Supplier and the end user (surgeon) for information related to the Product.
Supplier will provide Distributor, according to reasonable needs, with commercial literature or brochures in English, and all other data that could help the promotion of the Products. All documents over a certain weight or value, or documents required in large quantities or in another language, will be at the charge of Distributor and validated by Supplier, provided that they are compliant with the applicable laws, including but not limited to the laws of the Territory.
Supplier shall inform Distributor of substantial technical changes made to the Products. Sufficient information shall be given to Distributor to enable it to assess any and all innovation or improvements which will help Distributor to sell the Product.
Supplier may support Distributor for specific local registration and will provide all the requested documents that are not judged confidential. All expenses due to this registration will be at Distributor’s charge. For that purpose, Supplier will provide Distributor with a quotation for approval, including all the necessary expenses such as document legalization, additional and specific tests, translations, working time of Supplier’s regulatory team when applicable.
1.7 Shipping and storage conditions
Distributor shall ship, store and handle the Products in conditions of adequate cleanliness, hygiene, temperature and humidity control in accordance with Supplier’s quality requirements as recited in the Instructions For Use (IFU) and the label.
Distributor shall sell the Product(s) without any change in its original packaging, in accordance with the instructions set out in the IFU and label.
Supplier shall supply the Products with proper packaging bearing instructions labels, and Distributor will resell the Products in their original, unopened packages. Distributor may however, attach to the outside packaging a label bearing the name and address of Distributor without covering any prior information.
Supplier will pack the Products in such a manner as to provide adequate protection during transportation.
Products requiring a temperature-controlled environment will be sent by Distributor with a temperature indicator in each shipment for monitoring.
Distributor shall maintain product compliance regarding storage, handling of medical devices provided by the Supplier. Distributor shall have systems in place to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects do not occur during handling and storage of the medical devices provided by the Supplier when medical devices are exposed to the conditions defined and planned by the Supplier and to additional hazards during storage or handling. If specific conditions have to be respected, they have to be controlled and registered.
Distributors shall verify that the following requirements are met:
– The device has been CE marked and the EU declaration of conformity of the device has been drawn up,
– The device is accompanied by a label and an IFU in the languages of the Member States in which the device is made available in accordance with the applicable regulation,
– A UDI has been assigned to the device by the manufacturer,
– Where applicable, the information about the importer is on the device, on its packaging or in a document accompanying the device.
Both parties are under an obligation of confidentiality regarding:
– personal data,
– commercially confidential information and trade secrets, including intellectual property rights, unless disclosure is in the public interest,
– implementation of the Regulation, in particular for the purpose of inspections, investigations or audits.
General obligation to cooperate with the competent authorities that may require distributor to make available documentation, information, samples of or access to a device or to carry out announced audits and, if necessary, unannounced inspections of its premises.
2. Preserving documents
Distributor undertakes to preserve all the documents supplied by Supplier and keep them at the disposal of the competent authorities (Ministries of Health and Notified Organisations or updated registration outside the European Union) for a period of fifteen years (15 years).
Distributors shall keep a register of complaints, non-conforming devices and product recalls and communicate this follow-up or any other related information upon request by Supplier.
These documents must be retained in such a manner as to protect them against damage from the elements and theft. Records shall be readily retrievable to provide reasonable ease of access for review and shall be legible and stored to minimize deterioration and prevent loss. At the end of the retention period, the Supplier will be notified in writing, requesting that arrangements for picking up the documents from the Distributor be made or agreement to their destruction. In the event of termination of the business relationship between the Supplier and the Distributor, the Distributor must, unless otherwise agreed in writing, retain the above documents at importer until the end of the retention period. In the event of the liquidation of Distributor, the documents must be delivered to the Supplier without prompting and without additional cost.
3. Traceability of the product
Both parties shall apply traceability measures in order to guarantee the traceability of the Products throughout the production and distribution processes.
Distributor undertakes to guarantee the traceability of the Products from the premises of the Distributor Company up to delivery to the end user (surgeon).
Distributor shall be able to identify any economic operator to whom it has directly supplied a device, who has directly supplied it with a device and any health institution or healthcare professional to which it has directly supplied a device.
In particularly, Distributor shall store and keep, preferably by electronic means, the UDI of any class III implantable devices.
Supplier or a person delegated by Supplier may, if necessary, carry out an audit at the Distributor Company in order to verify distribution activities (in particular by questioning a batch recall).
Both Supplier and Distributor undertake to supply their own distributors with the documents listed below in order to guarantee the traceability of the Products, for each delivery, in addition to Product labels.
||Acknowledgement of receipt
|Name and address of the shipping package consignee
|Product Part Number
|Sterilisation expiry date
At Distributor’s request, a certificate of product compliance may be issued on each delivery. The information on the packing slip will be mentioned on the certificate of conformity.
4. Complaints and incidents
Distributor undertakes to play a real intermediary role between Supplier and the end user (surgeon) for information purposes pursuant to Regulation (EU) 2017/745 of European Parliament and of the Council of 5 April 2017 on medical devices, and 93/42/EEC. Distributor shall be aware of the in force MEDDEV 2.12-1.
Both parties undertake to keep each other mutually informed (in writing or in any other way which may be agreed between the parties) of any event listed below.
Distributor that has received complaints or reports from healthcare professionals, patients or users related to or possibly related to the product it has made available shall immediately forward this information to the Supplier but no later than two (2) working days.
In case of reportable incidents occurring to the Products covered by this Agreement, the Distributor shall immediately forward this information to the manufacturer but no later than two (2) working days while bearing in mind that the materiovigilance procedure is the responsibility of the Supplier, as the legal manufacturer.
Distributor that considers that a device is not in conformity shall inform the manufacturer and shall only make the device available once it has been brought into conformity. It shall also inform the competent authority if it considers the device presents a serious risk or is a falsified device.
Distributor shall return Nonconforming Products to Supplier for investigation and analysis. Distributor shall establish, maintain documentation for Nonconforming Product processes and follow the corresponding instructions in case of non-conforming Products. Distributor shall send documents and products within the timeframe requested by Supplier.
Distributor shall maintain a record of complaints, non-compliant Products. Upon review of the investigation report, Supplier reserves its right to require additional information as necessary and Distributor undertakes to cooperate with Supplier in addressing any further requests for information concerning a complaint.
In the event of an incident to be declared or the risk of an incident occurring with the Products and brought to the knowledge of the Supplier, the Supplier or a person delegated by Supplier due to its status of legal Supplier may, if necessary, carry out an audit at the Distributor company in order to evaluate the implication of the distribution activities in the incident or the risk of an incident. In the event that an audit is not necessary following an incident or the risk of an incident, Distributor undertakes to provide Supplier with all the written information necessary to enable a final report to be issued about the incident or the risk of an incident, which shall be submitted to the competent authorities. The Parties shall decide and agree whether or not to carry out such an audit.
Distributor shall take the appropriate corrective action when a competent authority identifies an unacceptable risk for health or safety. When a non-conformity does not present an unacceptable risk to health or safety, Distributor shall bring the non-compliance to an end within a reasonable period.
Distributor shall cooperate with competent authorities on any action taken to eliminate or mitigate the risks posed by devices which they have made available on the market. It shall provide competent authorities with free samples of or access to the device.
5. Product recall
As part of the medical device control procedures and in the event that Supplier should decide to recall a product, Distributor undertakes to provide the Supplier with detailed written information relating to the traceability of the Products. Due to its status of legal manufacturer, Supplier has the sole authority for decisions related to any Nonconforming Products in the field, including any field corrective action and thus shall be responsible for the materiovigilance procedure with the competent authorities.
For purposes of this materiovigilance and the recalls, Distributor shall promptly and fully cooperate in such FSCA, with all reasonable requests made by Supplier related to access to Product information and quality Records maintained by Distributor without additional cost to Supplier. Distributor undertakes to respond to Supplier ’s requests for information within 7 calendars days.
Distributor undertakes to communicate to the Supplier the outcome of the batch recall (number of returned devices) and to send back to the Supplier the returned devices.
Distributor shall maintain a record of batch recall. Upon review of the investigation report, Supplier reserves its right to require additional information as necessary and Distributor undertakes to cooperate with Supplier in addressing any further requests for information concerning a batch recall.
By virtue of its status of legal manufacturer, Supplier or any other person designated by Supplier may carry out audits in the distribution premises of Distributor in order to verify that the Products are stored, handled and shipped in such a way that the integrity and traceability of the Products are guaranteed up to their receipt by the end users. Distributor grants Supplier a comprehensive right to audit Distributor’s facilities and installations. For-cause audits shall be scheduled as quickly as possible, taking into consideration the urgency of the request.
The quality assurance manager of Distributor or any other person appointed by the latter may carry out a Supplier quality audit the schedule of which shall be agreed in advance between the two parties.
Notification of these audits shall be sent within a deadline agreed between the Parties.
An exit meeting will include review of any audit findings and observations. Supplier shall provide a written audit report to Distributor. Distributor shall provide a written response within thirty (30) days of receipt of the audit report. Distributor shall follow up to ensure that all corrections and corrective actions are implemented.