MDR Transition Extension Period: Understanding the New Regulation 2023/607 for Device and IVD Manufacturers
On January 6, the EU Commission finally took steps towards addressing…
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Navigating IVDR Compliance: Applicability of Scientific Validity for IVDs
While established over ten years ago as a concept by the precursor to the International Medical Device Regulators Forum (IMDRF),…
Best Practices for Conducting Literature Searches in IVDR Performance Evaluation
Just as in clinical evaluation, literature searches are critical in the performance evaluation process under the IVDR. Scientific (peer-reviewed)…
Understanding the Specific Evaluation Documentation Required for IVD Performance Under Article 56 of the IVDR
Specific IVD performance evaluation documentation required under Article 56 of the IVDR includes: Performance Evaluation Plan (PEP)…
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…
Shipping Devices and IVDs Directly to Consumers? | EU MDR Economic Operators
The EU MDR/IVDR establishes specific regulatory obligations for economic operators, including importers. The concept of “placing…
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…
Swiss IvDO: Fast-Approaching Deadlines for IVD Manufacturers
As we’ve previously reported for non-IVD devices, under the new Swiss Medical Devices Ordinance…
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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.
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