New
Trending
SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
IVD Classification and Performance Evaluation under the IVDR Course & Certification
Intermediate
Watch Preview
4.6
★★★★★
96% Recommended
3 hours
211 active users
3 points
Watch Preview
Your Study Basket
IVD Classification and Performance Evaluation under the IVDR
| Total | |
🎁 FREE Bonus Included
eBookWorth £29— Yours FREE when you purchase today.
VAT is levied as per your country’s applicable rules and rates at checkout
Save more with a monthly or annual plan that includes this course
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
The IVD Classification and Performance Evaluation under the IVDR course provides a practical understanding of IVD classification, performance evaluation, and regulatory requirements under Regulation (EU) 2017/746.
It covers Article 47 and Annex VIII on classification, Article 56 and Annex XIII on performance evaluation, scientific validity, analytical performance, clinical performance, performance studies, and post-market performance follow-up (PMPF). Learners also explore technical documentation, risk management, conformity assessment, and notified body expectations through practical scenarios.
Upon completion, learners receive a certificate demonstrating their understanding of IVD classification and performance evaluation requirements.
Who Should Enrol?
- Regulatory Affairs and Performance Evaluation Professionals
- IVD Manufacturers and Regulatory Consultants
- Laboratory Scientists and Clinical Research Professionals
- Quality Assurance and Quality Management Professionals
- Performance Evaluation, Risk Management and Technical Documentation Teams
- Professionals involved in EU IVDR compliance, conformity assessment, audits and inspections
What you will learn
Understand IVD classification rules, intended purpose, and regulatory requirements under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR).
Learn the three pillars of performance evaluation: scientific validity, analytical performance, and clinical performance, including evidence assessment and benefit-risk analysis.
Understand performance evaluation planning, performance studies, post-market surveillance (PMS), post-market performance follow-up (PMPF), and technical documentation requirements.
Develop knowledge of performance evaluation reports, conformity assessment, notified body expectations, and ongoing demonstration of IVD safety and performance under the EU IVDR.
Course Syllabus
- The input, and who writes it
- Drafting the intended purpose as a discipline
- The architecture, stated once and correctly
- The component-level problem
- Where classification sits, and where a disagreement goes
- What must be written down, and what nobody prescribes
- Two rules, not one
- Panels, and where unexpected class D comes from
- The class D population, and it is smaller than expected
- A rule read in its corrected form
- The class C engine, worked by archetype
- Three monitoring formulations, and two classes
- The residual end, the switch, and the exercise
- Companion diagnostics, on the reasoning the guidance uses
- IVD software: qualification first, then Annex VIII
- Self-testing: a closed list, and the rules above Rule 4
- Near-patient testing, and the second proposition in miniature
- The low end, and the boundary of the Regulation itself
- The reclassification case, worked end to end
- The open boundaries, and the machinery that does not close them
- The routes, by annex address
- The two steps that no class letter predicts
- Sampling, its two corrections, and the method behind them
- The two technical documentation annexes
- The class D pathway, end to end
- The reference laboratory position is two-speed
- The certificate, the figures, and what the figures do not say
- The pillars, by definition and by address
- Ordered and conditional, not three parallel workstreams
- The plan, at its own address and grouped by purpose
- The clinical performance carve-out, taken honestly
- The study decision, and where this course stops
- Where the analogy breaks, and what is not published
- The report, and the word the annex actually uses
- The update duty, settled against the article
- Post-market performance follow-up, by purpose
- Where this course stops, and what the other one owns
- The transition, and the hardest trap in the subject
- Three jurisdictions, and three separate answers
- The re-check list, the exercise, and the close
- The argument, and what has changed since the introduction
- The class is not the consequence, proved and not asserted
- Guidance moved a device, and the gates are conditions
- Drafted records - constructed
- A check to run over a classification rationale on file
- Course completion
- 📘 Bonus: IVD Classification and Performance Evaluation under the IVDR eBook (Free with purchase)
Course Benefits
eBook
Access the course content in eBook format, which can be downloaded and read on your device.
CPD Points
Earn CPD points by completing this course on IVD Classification and Performance Evaluation under EU IVDR, subject to the recognition requirements of the relevant professional body or CPD scheme.
Certification
Receive a personal certificate upon successful completion of the IVD Classification and Performance Evaluation under EU IVDR course, demonstrating your knowledge of IVD classification, performance evaluation and regulatory requirements.
Affordable
Get excellent value with cost-effective pricing for the IVD Classification and Performance Evaluation under EU IVDR course, with group discounts available for organisations and teams.
Flexibility
Learn online at your own pace and convenience, from any location, with our IVD Classification and Performance Evaluation under EU IVDR course.
Keep Up to Date
Stay up to date with EU IVDR requirements for IVD classification and performance evaluation, including Article 47, Annex VIII, Article 56, Annex XIII, relevant MDCG guidance, and evolving regulatory expectations for demonstrating the safety and performance of in vitro diagnostic medical devices.
Learn from Industry Experts
Learn from industry experts using EU IVDR requirements, including Article 47, Annex VIII, Article 56, Annex XIII, and relevant MDCG guidance. Understand IVD classification, performance evaluation, regulatory documentation, and conformity assessment through practical, evidence-based learning.
Our Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
Best Seller
