Inclusion of CH-REP in Communication on Vigilance Topics
Swissmedic has now specified that if the reporting is done by a manufacturer domiciled outside of Switzerland and Liechtenstein, the…
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 217–225 of 229
EC Regulation 2023/2197: UDI Assignment for Contact Lenses
The EC has decided to amend the MDR with regards to the assignment of Unique Device Identifiers (UDI) for Contact…
New MedDO Amendments Implemented by Federal Council
MHRA Update Regarding Adverse Incidents Reporting
As of August 31, 2023, there are changes to how adverse incidents involving medical devices should be reported to…
New Swissmedic Swissdamed Medical Device Registration
Due to the status of the agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the…
Medical Device Incident Reporting: Why Manufacturers Need to Be more Aware
The Dutch Health and Youth Care Inspectorate (the Inspectorate) suggests manufacturers be more aware of medical device incident reporting. In…
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…
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…
Showing 217–225 of 229