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.
Medical devices and healthcare auto
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.
Tags Events
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.
Tags News
Healthcare & Medical Devices Beauty & Personal Care Consumer Goods Industrial Mechanical Technology Innovation
Tags Blog
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.
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.
Ongoing process for the revision of the Machinery Directive
European Commission's revision of EU Machinery Directive expected in the second quarter of 2021. It's set to clarify definitions of new digital technologies.