If you export devices to the European Union, United Kingdom or Switzerland, you will need to appoint an “Importer of Record.”...

Ever since the United Kingdom (UK) left the European Union (EU), there have been lingering questions among medical device manufacturers...

Pre-Brexit, the United Kingdom was a member of European Union (EU). As such they were obligated to transpose the EU Medical Devices...

If you have been selling your medical devices or IVDs in Europe for some time, you’re probably aware of the requirements for identifying...

Many non-EU manufacturers are blissfully unaware that their German, French or Italian distributors are selling in Switzerland. Here’s why it

The European Medical Device Regulation (MDR 2017/745) took effect on May 26, 2021. Manufacturers holding valid Medical Devices Directive...

Selling in Europe used to be so simple. As recently as May 2021, CE Marking granted you unfettered access to all European Union...

Remember the good old days when the Medical Device Directive ruled and the United Kingdom was “united” with the rest of Europe? Alas,...

Once the new EU Medical Device Regulation (MDR) came into full force in May 2021, thousands of medical device manufacturers entered the...

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...

Many medical device manufacturers located outside the European Union have been wondering what to make of Article 13 of the European...

How do we break this to you gently? OK we can't. The blunt answer is no. Starting May 26, 2021 there are some aspects of the European...

Medical device regulations have been on the books for decades, long before software was widely used in medical devices, and certainly...

Article 13 of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require you to list your importer "on the...

As you know by now, Article 13 of the new European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) defines the...

A Single Registration Number is assigned to all medical device legal Manufacturers, Authorized Representatives, System/Procedure Pack...

Article 13 of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) includes a new requirement to appoint...

Article 13 of the European Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR) requires you to appoint an EU importer....

Many medical device companies exporting to Europe have discovered that there is a new requirement to appoint an importer in the Medical...

By now you certainly know that Article 13 of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require you...