The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional per...
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Swiss Database on Medical Devices – swissdamed!
Swissmedic released a comprehensive guidance document for the implementation of the Swiss Database on Medical Devices – swissdamed. Feel fully...
Important Announcement: CE-Marking Extensions and Medical Devices in the UK
The UK Government has made a significant announcement concerning CE-marking extensions, and we want to ensure absolute clarity on the matter. However,...
Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers
Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers We have some fantastic news for all medical device manufac...
Timelines for CE Marked Medical Device Placement in the Great Britain Market: UK MDR 2023 Update
UK MDR Update published! It is finally official! The Medical Devices (Amendment) (Great Britain) Regulations 2023 – statutory instrument 2023 No...
New timelines for CE marked medical devices to continue to be placed on the Great Britain market!
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...