Canada adopts risk-based approach to medical device legislation to increase safety and effectiveness. This is in keeping with new EU medical device regulation.
Medical devices and healthcare
Blog
Regulatory news and updates from Obelis. Your source for up-to-date information on developments in EU regulations, directives and compliance standards.
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.
Sidebar – Obelis visits Tokyo!
Special Tokyo sidebar content!
Services
Obelis safeguards your future in the European community through expert compliance, CE marking, regulatory consulting, and authorized representative services.
News
Keep updated on EU compliance and regulatory news from the medical and healthcare, cosmetics, consumer goods, technology and chemical industries and more.
Obelis UK Ltd established!
Obelis announce new Obelis UK Ltd to provide services for cosmetics manufacturers requiring a UK Responsible Person in the case of a 'no deal' Brexit.
Events
Find out how to meet the Obelis team at the next healthcare, medical device, or beauty and personal care trade fair or expo event near you.
How to Obtain a CE Mark (for a Medical Device)
Obelis' CE marking experts walk you through the simple 7-step process for obtaining a CE marking for medical devices and accessing the European market.
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.