Ensuring Compliance for Foreign Manufacturers of CE Marked ‘Legacy Devices’: Common Pitfalls and Solutions
As a regulatory representative for foreign manufacturers including those who are CE marked ‘legacy device’ in the EU, Switzerland and…
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The Relevance of Device Stability Studies to IVDR Performance Evaluation
Under the IVDR, the performance evaluation report (PER) is supported by three “sub-reports” comprising the scientific validity report (SVR),…
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…
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)…
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