Performance Evaluation Reports (PER)
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.
Services We Offer
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.
Performance Evaluation Report
Current Challenges related to PER
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
Artixio's Expertise
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
Performance Evaluation of In-Vitro Diagnostics
- Scientific Validity
- Cinical Performance
- Analytical Performance
- Clinical Evidence
Process of Preparing 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.
Specialized Registration
Services Across Multiple Industries
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Expert Regulatory Services To Streamline Compliance
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review
Regulatory Affairs Across Multiple Countries
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
Insights from Artixio - Tips & Articles
Pharma Manufacturing Booms in
Hildalgo had good pharmaceutical infrastructure and supply chain capabilities, but with no foreign investment...
UK Releases Amendment &
In January 2025, MHRA UK released guidance on implementation of amendments to Medical Devices...
Artixio Announces Grant for
HYDERABAD, India - March 27, 2024 - Artixio, a leading compliance and commercial consulting...