MDR EU Regulation Requirements: Systems and Procedure Packs
Under Article 2 of the MDR, a “system” is a combination of products, either packaged together or not, which are…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 334–342 of 689
Updated Guidance for UK Virtual Manufacturers of Medical Devices: Compliance Requirements
Virtual manufacturers of medical devices that do not need UK Approved Body/EU Notified Body approval are still required…
CE Marked Medical Devices in Great Britain: Timeline Extended
The UK Government has introduced the Medical Devices (Amendment) (Great Britain) Regulations 2023, allowing CE marked…
Leveraging Device Clinical Data in Great Britain for IVDR Performance Evaluations
One of the challenges being experienced by IVD manufacturers, in meeting the requirements of the IVDR, is ensuring (and…
UK Extends Acceptance of CE Marked Medical Devices
The UK government has made changes to the UK MDR (2002) to extend the acceptance of CE…
IVDD vs IVDR: Greatest Impacts on IVD Manufacturers
The IVDR has brought about a paradigm shift in the regulatory framework for IVDs placed on the…
EU Device Regulatory Compliance: A Comprehensive Guide
While the focus of EU regulatory compliance for medical devices and…
EU Importation and Taxation Considerations: DDP vs DAP
Asides from the regulatory hurdles necessary to navigate when marketing your devices in the EU, taxation requirements are also…
MDR Clinical Evaluation Reports for Lower-Risk Class Devices
It is known that the main objective of the implementation of the MDR was to strengthen the regulatory framework…
Showing 334–342 of 689