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Medical devices: ECHA clarifies the scope of certain REACH …

    https://chemycal.com/news/969572bd-7185-4e71-8313-2917f8929ecd/Medical_devices_ECHA_clarifies_the_scope_of_certain_REACH_exemptions
    1 - The scope of REACH authorisation exemptions: ECHA clarifies that the “ use ” of substances exempted from REACH authorisation (e.g., use in medicinal products; food or feedingstuffs; plant protection products; biocidal products; etc.), …

REACH FAQs for Medical Device Professionals

    https://www.mddionline.com/regulatory-quality/reach-faqs-medical-device-professionals
    No, REACH applies to finished goods as well as to raw chemicals. Does REACH have any exemptions for medical devices? …

Exemptions? - ECHA - Europa

    https://echa.europa.eu/support/getting-started/am-i-exempt
    No company is exempt from the requirements for chemical safety, but you could have exemptions from REACH and CLP when other legislation applies. Total exemptions …

Legal aspects of REACH and the medical devices sector

    https://www.fieldfisher.com/en/insights/legal-aspects-of-reach-and-the-medical-devices-sector

    REACH in the Medical Device Sector | APA Engineering

      https://apaengineering.com/compliance-blog/reach-in-the-medical-device-sector
      REACH in the Medical Device Sector As REACH (Registration, Evaluation, and Authorization of Chemicals – EU Regulation No 1907/2006) is in full force, medical …

    Class I and Class II Device Exemptions | FDA

      https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions
      Preamendments devices (please refer to FDA’s guidance “ Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements ”); …

    Medical devices under REACH and RoHS

      https://www.packagingdigest.com/sustainability/medical-devices-under-reach-and-rohs
      Under REACH, “substances of very high concern” (SVHC) are identified and listed by ECHA, for eventual authorisation. Although the use of a SVHC for the manufacture of a medical …

    REACH - Exemptions

      https://www.iron-consortium.org/assets/files/reach/UK_REACH_exemptions.pdf
      Substances do not need to be registered under REACH if they are manufactured or imported at less than tonne per year, per manufacturer/importer. Some substances are …

    Understanding REACH Exemptions | Assent

      https://www.assent.com/resources/knowledge-article/understanding-reach-exemptions/
      The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation protects human health and the environment from the harmful effects of certain …

    International – REACH FAQs for Medical Device …

      https://www.ris.world/international-reach-faqs-for-medical-device-professionals/
      Medical devices need not address REACH-driven risks to human health when applying for authorization (this is presumably because risks to human health must be considered as part of the medical device …



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