Industry News
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.
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EU Commission to postpone MDR implementation following COVID-19 pandemic
The European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak.
Q&A: Device Manufacturers’ FAQs on the EU’s Medical Device Regulation (MDR)
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.
EU MDR: How Will Europe’s New Device Regulation Affect Software?
Medilink WM patron MasterControl provides an informative article, highlighting to industry that software must not be overlooked when considering MDR requirements and compliance.
UK SME readiness for the EU Medical Device Regulation
30th July 2019
Opportunity for UK SMEs to provide input and feedback to help inform government on impending MDR implementation
Impact of the new Medical Devices Regulation & In Vitro Diagnostic Medical Devices Regulation
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.
9 Steps to right first time regulatory compliance
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.
