Keep up to date with the latest news and information from Medilink West Midlands and our members across the Medical Technology and Life Science sectors, together with topical regional, national and international news.
The European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak.
The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will replace the Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD) beginning with the MDR that takes effect May 26, 2020.
Medilink WM patron MasterControl provides an informative article, highlighting to industry that software must not be overlooked when considering MDR requirements and compliance.
30th July 2019
Opportunity for UK SMEs to provide input and feedback to help inform government on impending MDR implementation
The regulatory landscape for medical devices is presently very challenging. Industry is well aware that the three year transition period from a directive to a regulation ends on the 15th of May 2020, whereupon the new regulatory framework (MDR) will apply in full. This will be followed in May 2022 with the new IVD regulations.
24th July 2018
By Medilink member, Three Circles. It can be a scary thought, regulatory compliance. So much to get your head around, so much to make sure is done right, and what is “right” anyway.