Manufacturers! Interested in the European Commission proposal for legacy devices? Our consultant will be offering an interpretation of the European Commission proposal for legacy devices regarding the following date: March 20, 2023
Medical devices and healthcare
What is CE Marking?
A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
Selling medical devices online in the EU
Complying with the rules on distance selling of medical devices and in vitro diagnostics device is a fundamental step when a manufacturer chooses to sell the devices online.
Seminar: Placing Medical Devices and In-Vitro Diagnostic Devices on the Union Market (EU) – News and Challenges
Medical Device and In-vitro Diagnostic Industry Discussion: Key Takeaways on IVDR and MDR Implementation Challenges
New legacy period for medical devices is official: automatic extensions and derogation for expired certificates
To prevent market disruptions and give manufacturers enough time to certify their medical devices under…
Covid tests under IVDR – How to sell them on the EU market?
The new EU Regulation on in vitro diagnostic devices (IVDR), applicable since May 26, 2022, affected the classification and compliance process of COVID-19 tests.
What manufacturers need to know about the new extensions for legacy devices
There was a general agreement between the Council of the EU representing the EU Member States and the European Commission to extend the transitional period (legacy period) to the Medical Devices Regulation (MDR). Read all the details in our article!
What is new in the European Standardisation system?
To modernise the European Standardisation System, the European Commission proposed to amend the Standardisation Regulation as part of its European Standardisation Strategy of February 2, 2022. Read all the details in our article!
European Authorised Representative (EAR) for manufacturers based in Turkey
There are few direct implications to the Customes Agreements for manufacturer of medical devices from Turkey. Read all the details in our article!
Post-Market Surveillance (PMS) and Vigilance: definitions and differences
Vigilance and Post-Market Surveillance definition, differences and their scope. Visit our webpage for all the details!