Amending Regulation (EC) No 1907/2006: A New Era for DEHP in Medical Devices
The European Union has recently made significant amendments to Regulation (EC) No 1907/2006, specifically concerning the use of bis(2-ethylhexyl) phthalate (DEHP) in medical devices. This change marks a pivotal moment in regulating chemical substances within the medical field. The Original Regulation: Regulation (EC) No 1907/2006, otherwise called REACH (Registration, Evaluation, Authorization and Restriction of Chemicals), […]
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 in this process. The document also discusses how the classification affects pre- and post-market regulatory […]
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 new regulation replaces the In Vitro Diagnostics Directive (IVDD) 98/79/EC. The new regulation is significant […]
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 and mends all aspects of battery design, performance and end of life. It introduces over […]