Canada adopts risk-based approach to medical device legislation to increase safety and effectiveness. This is in keeping with new EU medical device regulation.
Other Industries
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.
Which products fall under Personal Protective Equipment Directive PE 89/686/EEC
European Personal Protective Equipment Directive 89/686/EEC sets out a new categorization system for PPE products calling under the directive.
Heavy Metals in Cosmetics
Find out what implications EU cosmetics regulations have for the use of heavy metals (zinc, tin, lead, arsenic, cobalt, mercury, etc.) in cosmetic products.
Game Plan for Upgrading Compliance under Medical Device Regulation 2017/745
Since the introduction of EU Medical Device Regulation 2017/745, manufacturers have been rushing to prepare for it taking full effect on 25th May 2020. The best advice is to start getting ready for the transition now to ensure a smooth process with no negative effects. The first step in getting ready for MDR 2017/745 is understanding what it is and what requirements it has for manufacturers of medical devices. With that in mind, we put some information together to help clear the process up!