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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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