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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.
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.
Basics of the Medical Device Classification System
Discover what are the fundamental characteristics of the Medical Device Classification System.
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.
Commission’s communication campaign on MDR and IVDR – special notice to manufacturers
European Commission issues special notice to medical and in-vitro diagnostic device manufacturers to clarify scope and requirements of new EU regulations.
Incidents defined under the new Medical Device Regulation
Learn more about the definition and categorization of incidents as outlined by new EU medical device regulation 2017/745.
GPSD – steps to compliance
Learn more about the steps to compliance for your product under European General Product Safety Directive 2001/95/EC, from CE certification to the RAPEX system.
ECHA: EU investigates permanent cosmetics and tattoo inks
The ECHA has been conducting studies into harmonizing EU tattoo and permanent make-up safety processes and legislation across Europe.