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

Stakeholder organizations are invited to nominate observers for work on Annex XVI devices

Progress report on Notified Body designations to MDR, IVDR issued by European Commission

What no Mutual Recognition Agreement between Switzerland and the EU could mean for medical device manufacturers post-MDR

Eudamed nomenclature clarifications in new European Commission guidance

How senior management can support RA/QA staff meet new clinical data requirements under the European Medical Devices Regulation

European cyber requirements under MDR, IVDR hew closely to IMDRF recommendations