Oct 4, 2023
EU MDR/IVDR
This article highlights the importance of GSPR compliance for obtaining medical device approval in the European Market. Table of Contents The European Union (EU) has implemented stringent regulations and requirements for the approval and launch of medical devices...
Read More
May 27, 2021
EU MDR/IVDR
The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. This is a crucial process and should be carried out by Notified Bodies. Notified Bodies: Legal Status The new framework introduced by these...
Read More
May 26, 2021
EU MDR/IVDR
Today marks a landmark event for medical device manufacturers around the globe: the date of full implementation of the EU’s MDR. Starting today all new medical device registrations that fall within the scope of the European Medical Device Regulation (MDR) must be...
Read More
Jun 19, 2020
EU MDR/IVDR
The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...
Read More
Jun 8, 2020
Europe
The European Commission (EC), the EU authority responsible for medical devices regulation, issued a Q&A conformity document describing the approaches to verifying that medical devices and personal protective equipment (PPE) are allowed to be marketed and uses...
Read More