Medical Devices Under Reach

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Substances restricted under REACH - ECHA - Europa

https://echa.europa.eu/substances-restricted-under-reach

The table below is the Annex XVII to REACH and includes all the restrictions adopted in the framework of REACH and the previous legislation, Directive 76/769/EEC. Each entry shows a substance or a group of substances or a substance in a mixture, and …

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 …

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 …

Legal aspects of REACH and the medical devices sector

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

legislation-profile - ECHA - Europa

https://echa.europa.eu/legislation-profile/-/legislationprofile/EU-MEDICAL_DEVICES

The Directive applies to medical devices and their accessories (both termed as 'devices'). For the purpose of the directive, 'medical device' means any instrument, …

RoHS, REACH and the Rest: EU …

https://www.mddionline.com/regulatory-quality/rohs-reach-and-rest-eu-substances-regulation-applicable-medical-devices-and-ivds

REACH makes a distinction between medicinal products and medical and IVD devices, the latter including the likes of blood glucose meters, catheters, and contact lenses that, with their …

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 …

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

ECHA clarifies that the “ use ” of substances exempted from REACH authorisation (e.g., use in medicinal products; food or feedingstuffs; plant protection …

Manual on borderline and classification for medical devices …

https://health.ec.europa.eu/system/files/2022-09/md_borderline_manual_09-2022_en.pdf

This document, hereafter called the Manual, records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG)1 …

Fulfilling REACH chemical regulations for …

https://blog.dhigroup.com/2018/06/27/fulfilling-reach-chemical-regulations-for-medical-devices/

REACH stands for the Registration, Evaluation, Authorisation and Restriction of Chemicals. The regulation aims to protect human health and the environment through better and …

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