Blog

New guidance sheds more light on medical device regulatory compliance in the UK

Some manufacturers that want to show conformity to IEC 62366-1:2015 for user interfaces of devices may qualify for UOUP designation

New legislation is being rolled out in stages to match changing European regulations and prepare the ground for a Mutual Recognition Agreement.

Fourteen Notified Body designations to European MDR now entered into NANDO database

On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of...

Other countries that plan to adopt the legislation or align elements of their own regulatory systems with it must now decide how to proceed.

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.