Technical Documentation Files Review: Top 5+ Mistakes by Manufacturers
As a regulatory representative for foreign manufacturers in the EU, UK, US and Switzerland, MedEnvoy reviews technical documentation files of…
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Understanding Clinical Performance Reports(CPR) under the IVDR: A Guide for IVD Manufacturers
‘Clinical performance’ is not a novel concept in the transition from the IVDD to the IVDR; however, the applicability of…
Analytical Performance Characteristics for IVDs: What Manufacturers Need to Know
While ‘analytical performance’ is not a novel concept in the transition from the IVDD to the IVDR, it has been…
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…
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…
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