mdi Consultants
People rely on medical device ranging from simple contact lenses to sophisticated pacemakers to improve the health and quality of life and so expect them to be safe and incorporate the latest progress in science and innovation. To reflect the substantial technological and scientific progress in this sector over the last 20 years, the European Commission on April 5th adopted MDR and IVDR to improve the safety of medical devices for EU citizens, create the conditions to modernize the sector and to consolidate its role as a global leader.
The new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological advances. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation.
The new rules will go into effect three years after publication for the regulation on medical devices and five years after publication for the regulation on in-vitro diagnostic medical devices.
To comply with the traceability rules, medical device manufacturers will need to update their device labels to include UDI information a next generation labeling system that will help them empower business, eliminate label errors and streamline the supply chain.
For more information about the new regulation please visit the Nice Label Blog
For Frequently asked question about the new EU regulation please visit “EU Rules Frequently Asked Questions”
Please visit the link for a overview about Medical Device Regulations in Europe
? For any questions or comments or your regulatory requirement please email to info@mdiconsultants.com or use our contact form.