Under EU medical device directive 93/42/EEF, all medical device manufacturers not registered in the EU mush designate an EU Authorized Representative.
Medical devices and healthcare
ECHA’s public consultations on the restriction dossier for intentionally added microplastics
ECHA-prepared restriction dossier on the use of synthetic microplastics in EU products is open to public consultation until September 20th, 2019.
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Healthcare & Medical Devices Beauty & Personal Care Upcoming Events
What is Eudamed?
Learn more about the new European Databank on Medical Devices and its role in strengthening market surveillance and transparency across the EU.
NB-MED Performed a survey on IVDR Readiness of the Notified Bodies
Read more about the results of NB-MED's 2019 survey on the readiness of Notified Bodies for the new In-Vitro Device Regulation in Europe.
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Healthcare & Medical Devices Beauty & Personal Care Consumer Goods Industrial Mechanical Technology Innovation
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Healthcare & Medical Devices Beauty & Personal Care Chemicals Consumer Goods Industrial Mechanical Technology Innovation
Support Point-of-Care Scanning of UDI Data for Implantable Devices: new GS1 guidance
Standards development body GS1 issues implementation guidelines for point-of-care UDI data scanning support for implantable devices across Europe.
ISO Standards on packaging for terminally-sterilized medical devices (2019 Update)
All you need to know about the 2019 update to ISO 11607-1 and its implications for terminally sterilized medical device packaging.
K-REACH Pre-registration Started from 1st January 2019!
Amendments to the Korea Reach act will have implications for chemicals being imported and exported to Korea. It enters effect on January 1st 2019.