We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in its latest status report. Read More
The EU’s Medical Device Coordination Group released new guidance on cybersecurity requirements for devicemakers under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Read More
The European Medicines Agency released a new question and answers document on its Medical Devices Regulation and In Vitro Diagnostic Regulation in an attempt to answer mounting questions from industry. Read More
The European Commission released guidance on qualifying software under the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Read More
Devicemakers planning to market products in the European Union need to understand new EU rules that spell out when clinical research is required and impose requirements for conducting trials. Read More
Devicemakers were critical of the European Commission’s specifications for reprocessing single-use devices, with many comments raising concerns about specifications were released earlier this summer. Read More
The European Commission issued new guidance on when devicemakers operating in the EU need to issue Field Safety Corrective Actions and how they should prepare field safety notices. Read More
France’s National Medicines Agency has established a pilot project to prepare for implementation of the new EU Medical Device Regulation and In Vitro Diagnostics Regulation. Read More
With less than one year before the EU’s Medical Device Regulation takes effect, an industry group is raising increasing alarm about the lack of “essential guidance” and the shortage of notified bodies needed to certify products in compliance with the new requirements. Read More