Medical Device Regulations and Registration in Canada (Health Canada)
In Canada, the medical devices are regulated by Health Canada under Health Products and Food Branch, Therapeutic Products Directorate,...
Every IVD is required to have a Performance Evaluation Report in accordance with the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) (PER). The three pillars of PERs are clinical performance, analytical performance, and scientific validity.
For IVD makers, gathering data to adequately address each pillar must be a top concern. Notified bodies won't work with manufacturers that can't show that they have procedures in place for IVDR compliance because of the pressure and resource constraints they are under.
Lack of expertise in authoring and updating Performance Evaluation Report
Scarcity of qualified writers and evaluators with profound knowledge on In Vitro diagnostics
Lack of effective planning to compile and submit the PER’s to Notified bodies meeting regulatory requirements
Lack of management practices aimed at timelines meeting regulatory changes
Regulatory champions with experience in authoring Performance Evaluation Reports for In-Vitro Diagnostics (IVD)
Clinical and Medical Professionals with decades of experience in evaluating clinical reports
Notified Bodies experience to precisely recommend strategy for Right First Time reports
Streamlined Project Management to meet regulatory timelines
Stage 1
Identify clinical evidence from:
•Literature search and/or
•Clinical experience and/or
•Clinical performance studies and
•Analytical performance studies
Generate new or additional analytical/ clinical data
No
Is clinical evidence sufficient to be able to declare conformity with relevant ERs?
Yes
Stage 2
Appraisal of individual data sets:
•Suitability
•Contribution of results to demonstration of performance and safety
Stage 3
Analysis of relevant data:
•Strength of overall evidence
•Conclusion about performance and safety
Performance Evaluation Report