-Jan 8, 20211 min readGMDN Agency welcomes UK-wide Medical Device Information SystemFrom 1st January 2021 all medical devices placed on the market must be registered by their manufacturers with the MHRA as part of a...
-Nov 4, 20201 min readClaiming Equivalence Under the EU MDRClaiming equivalence with a device that is already CE marked can help medical device companies save time and money. But scandals with...
-Oct 26, 20201 min readPlacing medical devices on the UK market after the end of Brexit transitionUKCA mark and Northern Ireland mark (UKNI) Manufacturers who are not supplying the EU/EEA markets might prefer the UK regulatory system...
-Sep 23, 20201 min readEU MDR costing smaller medtechs 5% of their annual sales: surveyAlmost half of medtech companies expect to spend 5% or more of their annual revenue on the EU Medical Device Regulation, results of a...
-Apr 21, 20201 min readPlacing Personal Protective Equipment (PPE) on the MarketBSI Webinar - Information for organizations wishing to support the efforts to place more Personal Protective Equipment (PPE) on the...
-Apr 20, 20201 min readCOVID-19: EU standards for PPE supplies made freely available Coronavirus: European standards for medical supplies made freely available to facilitate increase of production In the context of the...