The UK government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023! Subject to Parliamentary approval, the UK pl...
Implementation of Future Regulations for Medical Devices in the UK
The UK government is planning a substantial reform of the current regulatory framework for medical devices in the country. In response to the 2021 con...
UK Guidance update with MORE Submissions & Production API
The UK government has recently updated its guidance for CE marked medical devices in Great Britain with new information on MORE Submissions and Produc...
Crafting an Intended Purpose for Software as a Medical Device (SaMD)
Software as a Medical Device (SaMD) As a Software Medical Device (SaMD) manufacturer, you know that regulatory compliance is key to market success. De...
The UK and Switzerland have embraced the EU MDR extension!
The EU currently leads the way in regulatory standards, with the UK and Switzerland following suit. This is being done for valid reasons, as medical d...
Q & A – new Manufacturer Incident Report (MIR) Form
In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website....
New Vigilance documents published on the European Commission website!
The following important vigilance documents have been published on the European website: Additional guidance on the MEDDEV 2.12/1 rev.8 Device speci...
