New MHRA Guidance on Clinical Investigations Notifications
On 27 August 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released an updated set of flow charts…
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 1–9 of 11
Great Britain Medical Device Registration
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), under the jurisdiction of the UK Department of Health and…
EU MDR
Swiss Importer
EU IVDR
EU Importer
General
UK Responsible Person
UK Importer
Swiss Authorized Representative
Consolidating Authorized Representative and Importer Roles Pros and Cons
In this article, we share the advantages and disadvantages associated with consolidating the roles of authorized representative and importer.
Responsibilities of a SaMD Importer
As we’ve noted in a previous article, under the EU Medical Device Regulation (MDR) 2017/745 and…
The Difference Between a UK Importer and Responsible Person
For medical device and IVD manufacturers selling in the UK, much has changed in the last few years. First, the obvious: the UK is no longer part of the European Union.
Importer of Record- What is it?
If you export devices to the European Union, United Kingdom or Switzerland, you will need to appoint an “Importer of Record.” Understandably, many...
UKCA and UKNI Marks – All You Need to Know
Ever since the United Kingdom (UK) left the European Union (EU), there have been lingering questions among medical device manufacturers about how the new UK regulatory
Post-Brexit Medical Device Regulation- All You Need to Know
Pre-Brexit, the United Kingdom was a member of European Union (EU). As such they were obligated to transpose the EU Medical...
Medical Device Labeling Requirements in Europe
If you have been selling your medical devices or IVDs in Europe for some time, you’re probably aware of the requirements for identifying your EU Authorized...
Showing 1–9 of 11