With 12 months to go until European Medical Device Regulation 2017/745 comes into effect in May 2020, we look at how to prepare your products for compliance.
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Do I need an EAR if I have a Notified Body?
Though both are involved in the EU Compliance process and CE Marking, a European Authorized Representative and a Notified Body are not mutually exclusive bodies. Both have roles unique to themselves throughout the EU Compliance procedure. In order to clear up a few common misconceptions regarding European Authorized Representatives (EAR) and Notified Bodies (NB), this blog will outline the definitions and roles of each.
EAR for MDD I (non-measuring, non-sterile) products
Under EU medical device directive 93/42/EEF, all medical device manufacturers not registered in the EU mush designate an EU Authorized Representative.
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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.
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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.
Canadian medical device legislation develops in the same direction as EU MDR
Canada adopts risk-based approach to medical device legislation to increase safety and effectiveness. This is in keeping with new EU medical device regulation.