European Medical Device Directive Phthalates

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Guidelines on phthalates in medical devices - Public Health

https://health.ec.europa.eu/other-pages/health-sc-basic-page/guidelines-phthalates-medical-devices_en

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the final version of the Guidelines on the benefit-risk assessment of the presence, in the medical devices specified in the …

Phthalates - ECHA - Europa

https://echa.europa.eu/hot-topics/phthalates

As phthalates are not chemically bound in the materials they are added to, they can easily leach out or evaporate. Several ortho-phthalates, for example DEHP, …

Guidelines on phthalates in medical devices finalized!

https://mdlaw.eu/mdr/guidelines-on-phthalates-in-medical-devices-finalized/

on September 10, 2019 Independent scientific committee SCHEER published the final Guidelines on the benefit-risk assessment of the presence in certain medical …

Phthalate Regulations in the European Union: An …

https://www.compliancegate.com/phthalate-regulations-european-union/

Phthalates are chemicals used to improve the flexibility and durability of certain plastics. Phthalates may also be linked to certain cancers, metabolic disorders, …

Medical Device Regulation comes into application

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application

Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. The …

European Medical Device Directive - Essential …

https://www.tga.gov.au/sites/default/files/devices-forms-ecmra-ep-checklist.pdf

In parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

EU Expands Restriction of Phthalates …

https://www.sgs.com/en/news/2019/01/safeguards-00219-eu-expands-restriction-of-phthalates-under-reach

In March 2018, the World Trade Organization (WTO) announced a proposal from the European Union (EU) to amend the restriction of three phthalates (DEHP, DBP and BBP) under entry …

DEHP phthalates in medical devices - GOV.UK

https://www.gov.uk/government/publications/dehp-phthalates-in-medical-devices/dehp-phthalates-in-medical-devices

Phthalates are chemicals added to polyvinyl chloride ( PVC) plastic to make it softer and more flexible. Di (2-ethylhexyl) phthalate ( DEHP) is the type used the most …

Medical Devices Containing Phthalates - terumo-europe.com

https://www.terumo-europe.com/SiteCollectionDocuments/About%20Terumo/medical-devices-containing-phthalates.pdf

(*) Directive 67/548/EEC is being repealed by Regulation 1272/2008 The only phthalate classified as carcinogenic, mutagenic or toxic to reproduction (CMR), of category 1 or 2, …

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