Regulatory

GMDN Agency welcomes UK-wide Medical Device Information System

From 1st January 2021 all medical devices placed on the market must be registered by their manufacturers with the MHRA as part of a...

Claiming Equivalence Under the EU MDR

Claiming equivalence with a device that is already CE marked can help medical device companies save time and money. But scandals with...

Placing medical devices on the UK market after the end of Brexit transition

UKCA mark and Northern Ireland mark (UKNI) Manufacturers who are not supplying the EU/EEA markets might prefer the UK regulatory system...

EU MDR costing smaller medtechs 5% of their annual sales: survey

Almost half of medtech companies expect to spend 5% or more of their annual revenue on the EU Medical Device Regulation, results of a...

Placing Personal Protective Equipment (PPE) on the Market

BSI Webinar - Information for organizations wishing to support the efforts to place more Personal Protective Equipment (PPE) on the...

COVID-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...