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 […]