Artixio Consulting
Malaysia - Medical Devices Regulations
Medical Devices in Malaysia re regulated by Malaysian Medical Device Authority (MDA). The Medical Devices need to be registered in Malaysia
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Performance Evaluation Reports (PER)
Performance Evaluation Report
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.
Current Challenges related to PER
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Lack of expertise in authoring and updating Performance Evaluation Report
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Scarcity of qualified writers and evaluators with profound knowledge on In Vitro diagnostics
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Lack of effective planning to compile and submit the PER’s to Notified bodies meeting regulatory requirements
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Lack of management practices aimed at timelines meeting regulatory changes
Artixio's Expertise
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Regulatory champions with experience in authoring Performance Evaluation Reports for In-Vitro Diagnostics (IVD)
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Clinical and Medical Professionals with decades of experience in evaluating clinical reports
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Notified Bodies experience to precisely recommend strategy for Right First Time reports
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Streamlined Project Management to meet regulatory timelines
Performance Evaluation of In-Vitro Diagnostics
Analytical Performance
Scientific
Validity
Clinical Performance
Clinical Evidence
Process of Preparing Performance Evaluation Report
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
Artixio is helping IVD manufacturers globally with preparation of Performance Evaluation Report for their products.
We look forward to hearing from you.
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