11 Nov
Compliance Update Alert: MDR introduces 22 new rules to classify medical devices

A comprehensive guide to medical device classification EU was published on October 20, 2021 by The Medical Device Coordination Group (MDCG). MDCG guidelines are detailed in a 57-page document, detailing how medical devices are classified, and providing rules to help […]

Read More
16 Jul
Everything you need to know about In Vitro Diagnostic Regulation – (IVDR)

The “In Vitro Diagnostic Regulation” (IVDR) is a new regulation by the EU applicable for In Vitro Diagnostic (IVD) Medical Devices. The IVDR came into effect on May 25, 2017, with a five-year transition period for manufacturers and suppliers. The […]

Read More
2 Mar
EU Compliance Outlook 2021

Here is the snapshot of most important developments that we can expect in 2021, by European Union. EU Batteries Regulation A proposal for EU batteries laws were published on Dec 2020. This proposal will fully replace replacing the existing directive […]

Read More