Planning for Performance Evaluation Under the IVDR
Even for those that have prepared a performance evaluation summary document for an IVD CE marked under the IVDD…
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How IVD Manufacturers Can Prepare for IVDR Labeling Requirements
Given their scope, the labeling requirements established under the IVDR can be daunting for manufacturers, even for legacy device…
EU MDR
Swiss Importer
EU IVDR
EU Importer
General
UK Responsible Person
UK Importer
Swiss Authorized Representative
Consolidating Authorized Representative and Importer Roles Pros and Cons
In this article, we share the advantages and disadvantages associated with consolidating the roles of authorized representative and importer.
New Product Liability Directive Proposal | Medical Devices/IVDs
More than 30 years since the Product Liability Directive (PLD) was established and after the Commission assessed its regulatory…
Outline of the EU IVDR 2017/746: New Rules For Classification
One of the (many) significant changes brought about by the EU In Vitro Diagnostic Medical Device Regulation…
Why You Need To Get MDR Certification In 2023
If your plan was to wait until 2023 to leisurely address compliance with the Medical Device Regulation (MDR 2017/745) and…
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..
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 Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Do EU MDR Requirements Apply to You If You Have a Valid MDD CE Certificate?
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 Regulation (MDR 2017/745)
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