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...

No doubt you landed here because you did some research and figured out that you now need an EU-based importer. Perhaps you have been...

MedEnvoy established MedEnvoy UK Ltd to be able to offer UK Importer Services! From our office in London we can support non-UK legal...