It is the course’s goal to inform about the Medical Device Regulation (EU) 2017/745 coming into force on 26th May 2021 and the UDI-marking requirements in Europe and US. Generally, the challenges and solutions how to comply with the requirements of Medical Devices and Unique Device Identification (UDI) in the different markets are core content of this course. Best practice examples will demonstrate how the new European and International regulations on medical devices can be put into practice. This course will also explain the impact of MDR on the labelling and artwork of medical device packaging.
• What are the EU and US MDR/IVDR regulations?
• What changes will happen and when?
• What are the Impacts on packaging and labelling?
• Product re-registration
• Labelling content
• Adoption of UDI marking
• What is then impact of MDR on the labelling and artwork of medical device packaging?
Who should attend?
Manufacturers of medicinal products and manufacturers of medical devices within the field of requirements for Artwork Management, Packaging specification and typesetting.