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
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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...
UK MHRA: Why Medical Device & IVD Manufacturers Exporting to the UK Need an Importer
Remember the good old days when the Medical Device Directive ruled and the United Kingdom was “united” with the rest of Europe? Alas, relationships often...
You Must Have an EU MDR Importer, Even if Only Exporting MDD Certified or Self-Declared Devices
Once the new EU Medical Device Regulation (MDR) came into full force in May 2021, thousands of medical device manufacturers entered...
EU Language Translation Requirements for Medical Devices
Yes, it’s true. No, it’s not new. Yes, you need to take it more seriously than ever before. Here’s why. (Or skip the explanation and go directly to the language requirements..
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