Swissmedic: How Medical Device Regulation Has Changed
Swissmedic has implemented new requirements for manufacturers to continue selling medical devices in Switzerland which we will explore below. But…
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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...
Selling Medical Devices in Switzerland? Common Troublesome Scenarios for Manufacturers
Up until the new EU Medical Device Regulation (MDR) went into effect in May 2021, the European Union and Switzerland operated under...
LEGACY MDD | EU MDR Implementation Needed Now
The European Medical Device Regulation (MDR 2017/745) took effect on May 26, 2021. Manufacturers holding valid Medical Devices Directive (MDD) CE Marking...
CH-REP and Importer Now Needed When Exporting Medical Devices to Switzerland
Selling in Europe used to be so simple. As recently as May 2021, CE Marking granted you unfettered access to all European Union countries...
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