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Part Four of our series on the EU MDR and human factors engineering considerations

Two European Notified Bodies now delisted from NANDO database

The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two...

European Parliament overwhelmingly approves one-year MDR delay

Part Three in our series examining human factors engineering (HFE) requirements under the European MDR

European regulators officially propose delaying Medical Devices Regulation date of application in order to deal with COVID-19 challenges

Potential MDR delay reflects shifting EU priorities regarding COVID-19 pandemic

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new documents and announcements relating to the pandemic.

Part two of our blog series addresses the critical task of stating and designing for a medical device's exact use function.

The Medical Device Coordination Group (MDCG) released its first three guidances of 2020 and two revised documents.

European MDCG Joint Implementation plan for MDR ahead of May 26, 2020 compliance deadline

Part one of our series on human factors engineering and usability requirements under the EU MDR.

The Medicines and Medical Devices Bill continues to advance through the House of Commons.

The draft legislation offers hints at what the UK's independent regulatory framework might look like.

UK MHRA to provide case-by-case grace periods to medical device manufacturers in need of new Notified Body partners