Arkema does not supply any products to be used in medical device applications that constitute a non-temporary implant (i.e., that, in whole or in part, may be in contact with a patient’s skin, body fluids or tissues for more than 30 days).
Arkema may supply products to be used in medical device applications involving temporary implants (30 days or less) in contact with a patient’s skin, body fluids or tissues. Arkema only supplies customers with products for temporary implants in accordance with its medical contractual provisions, and where other specific corporate risk management conditions are met.
Other Medical Device Applications (Non Implant)
Arkema may supply products for use in all other medical device applications. Arkema will use its good business judgment to set specific Arkema corporate risk management conditions in such circumstances.
Design, Manufacture and Sale of Medical Device
Arkema does not design, manufacture and/or directly sell any medical devices. Arkema also does not co-design, or offer assistance to any purchaser of Arkema products, in their design, manufacture and/or sale of products for medical devices.
Medical Grade products
Arkema has designated specific medical grade compositions for its products. Customers who intend to use Arkema products in a medical device application will only be supplied with these specific medical grade compositions. No other Arkema products may be supplied for use in medical device applications.
Appropriate Use of Arkema Products
Arkema will not itself perform clinical medical studies concerning the use of its products for any particular medical device application. Arkema will not engage in any type of suitability determinations for the use of its products in any medical device applications
Responsibility of Medical Device Manufacturer
- It is the sole responsibility of the manufacturer of the medical device to determine the suitability (including biocompatibility) of all new raw material, products and components, including any medical grade Arkema products, in order to ensure that the final end-use product is safe for its end use; performs or functions as intended; and complies with all applicable legal and regulatory requirements.
- It is the sole responsibility of the manufacturer of the medical device to conduct all necessary tests and inspections and to evaluate the medical device under actual end-use requirements and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks and fulfill any postmarket surveillance obligations. Any decision regarding the appropriateness of a particular Arkema material in a particular medical device should be based on the judgment of the manufacturer, seller, the competent authority, and the treating physician.
Unless Arkema expressly agrees by written contract, Arkema product names, trademarks and the Arkema name shall not be used with any medical devices, and customers should not represent to others that Arkema permits, recommends, or endorses the use of its products in any medical devices.
ARKEMA WILL NOT WARRANT THAT ITS PRODUCTS ARE SUITABLE FOR USE IN ANY MEDICAL DEVICE OR MEDICAL APPLICATION.