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Edgar Kasteel
- Mar 24
- 1 min
How Your Medical Device Importer of Record Differs from Your Regulatory Compliance Importer
If you export devices to the European Union, United Kingdom or Switzerland, you will need to appoint an “Importer of Record.”...
161 views

Daryl Wisdahl
- Mar 14
- 4 min
UKCA and UKNI Mark for Medical Devices and IVDs: What, When, Why and How.
Ever since the United Kingdom (UK) left the European Union (EU), there have been lingering questions among medical device manufacturers...
169 views

Edgar Kasteel
- Feb 28
- 3 min
Overview of the UK MDR Medical Device Regulations and Post-Brexit MHRA Registration Process
Pre-Brexit, the United Kingdom was a member of European Union (EU). As such they were obligated to transpose the EU Medical Devices...
127 views

Edgar Kasteel
- Jan 31
- 3 min
European Medical Device Importer and Representative Labeling Requirements
If you have been selling your medical devices or IVDs in Europe for some time, you’re probably aware of the requirements for identifying...
350 views

Edgar Kasteel
- Dec 29, 2021
- 2 min
Selling Your Medical Devices in Switzerland? Common Scenarios that Get Manufacturers Into Trouble
Many non-EU manufacturers are blissfully unaware that their German, French or Italian distributors are selling in Switzerland. Here’s why it
168 views

Rene van de Zande
- Oct 26, 2021
- 4 min
Yes, Manufacturers of “Legacy MDD” Medical Devices Really Do Need an EU MDR Importer….NOW
The European Medical Device Regulation (MDR 2017/745) took effect on May 26, 2021. Manufacturers holding valid Medical Devices Directive...
518 views

Edgar Kasteel
- Aug 9, 2021
- 3 min
Exporting Medical Devices to Switzerland? You Now Need an Importer and Authorized Representative
Selling in Europe used to be so simple. As recently as May 2021, CE Marking granted you unfettered access to all European Union...
662 views

Edgar Kasteel
- Aug 4, 2021
- 3 min
Why Medical Device & IVD Manufacturers Exporting to the UK (Now) 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,...
91 views

Edgar Kasteel
- Jul 5, 2021
- 3 min
Yes, 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 the...
324 views

Rene van de Zande
- Jun 29, 2021
- 5 min
European Language Translation Requirements for Medical Device Labeling, IFUs and Software
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...
1,839 views

Rene van de Zande
- May 26, 2021
- 3 min
What Happens If We Don’t Appoint an EU MDR Importer?
Many medical device manufacturers located outside the European Union have been wondering what to make of Article 13 of the European...
371 views

Edgar Kasteel
- Apr 28, 2021
- 3 min
Our device has a valid MDD CE certificate. We don't need to comply with the EU MDR right?
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...
436 views

Edgar Kasteel
- Apr 22, 2021
- 3 min
We Sell Software as a Medical Device (SaMD). Do We Need an Importer for EU MDR/IVDR Compliance?
Medical device regulations have been on the books for decades, long before software was widely used in medical devices, and certainly...
519 views

Rene van de Zande
- Apr 12, 2021
- 2 min
How to Use the New EU Importer Symbol on Your Medical Device or IVD
Article 13 of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require you to list your importer "on the...
2,628 views

Rene van de Zande
- Apr 1, 2021
- 3 min
The Hidden Cost of Having a Distributor Act as Your EU MDR or IVDR Importer
As you know by now, Article 13 of the new European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) defines the...
132 views

Edgar Kasteel
- Mar 18, 2021
- 2 min
What is the EUDAMED SRN (Single Registration Number)?
A Single Registration Number is assigned to all medical device legal Manufacturers, Authorized Representatives, System/Procedure Pack...
5,038 views

Rene van de Zande
- Mar 15, 2021
- 3 min
How do the responsibilities of the EU Importer differ from the EU Authorized Representative?
Article 13 of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) includes a new requirement to appoint...
841 views

Edgar Kasteel
- Mar 15, 2021
- 2 min
Does our EU importer need to take physical possession of our medical devices?
Article 13 of the European Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR) requires you to appoint an EU importer....
260 views

Rene van de Zande
- Mar 1, 2021
- 3 min
Can we appoint multiple EU Importers in compliance with the EU MDR and IVDR?
Many medical device companies exporting to Europe have discovered that there is a new requirement to appoint an importer in the Medical...
536 views

Edgar Kasteel
- Feb 9, 2021
- 3 min
Where do we need to identify EU importer on medical device labeling?
By now you certainly know that Article 13 of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require you...
1,633 views