Reach Medical Device Exemption

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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.), under Article 2 (5) …

Exemptions? - ECHA - Europa

https://echa.europa.eu/support/getting-started/am-i-exempt

REACH applies for any substance, mixture or article you recover from waste that meets the end of waste criteria. It is however sometimes possible to get an exemption for a …

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

REACH FAQs for Medical Device Professionals

https://www.mddionline.com/regulatory-quality/reach-faqs-medical-device-professionals

REACH FAQs for Medical Device Professionals. The EU regulation may have been around for more than a decade, but there is …

Legal aspects of REACH and the medical devices sector

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

One of the immediately applicable requirements affecting suppliers of medical devices is the duty to communicate information about the presence of SVHCs in articles (Article 33, …

REACH in the Medical Device Sector | APA Engineering

https://apaengineering.com/compliance-blog/reach-in-the-medical-device-sector

Compliance Blog. REACH in the Medical Device Sector. As REACH (Registration, Evaluation, and Authorization of Chemicals – EU Regulation No …

REACH - Exemptions

https://www.iron-consortium.org/assets/files/reach/UK_REACH_exemptions.pdf

Total Exemptions Substances which fall into any of the categories below are totally exempted from the requirements of REACH [reference: REACH Article 2(1), (2) and (3)]; …

All news - ECHA - Europa

https://www.echa.europa.eu/-/endocrine-disrupting-properties-to-be-added-for-four-phthalates-in-the-authorisation-list

ECHA has submitted a recommendation to the European Commission to amend Authorisation List (Annex XIV of REACH) entries by adding the endocrine …

Medical devices under REACH and RoHS

https://www.packagingdigest.com/sustainability/medical-devices-under-reach-and-rohs

The EU Directive on the Restriction of Hazardous Substances (RoHS) covers electrical and electronic equipment. Until recently, medical devices were outside the scope of the …

RoHS 3 medical devices - StarFish Medical

https://starfishmedical.com/blog/rohs-3-impact-on-medical-devices/

Interestingly, medical devices have special rules for these four substances: The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring …

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