Presented by
Management Forum
Deep Dive into the IVDR (In-Vitro Diagnostic Regulation) Annex XIII Training Course
Explore IVDR Annex XIII in-depth, covering Performance Evaluation, Performance Studies, and Post-market Performance. Learn what information is required, where to put it, and when, with a detailed review of nine essential documents.
5 November 2024
+ 5 March 2025, 10 July 2025, 5 November 2025 »
from £549
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
Course overview
Understand where, when and how performance evaluation should be undertaken during the life cycle of an IVD device under the IVDR (2017/746).
The EU In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, came into force in May 2017, with an initial transition period of five years, and an intention to strengthen the current approval system for in vitro diagnostics in Europe through an evidenced based Notified Body review system. A key area of change is the minimisation of self-certification, and the introduction of mandatory documentation for the planning and reporting of the manufacturer’s clinical evidence to demonstrate the safety and effectiveness of the IVD device under evaluation.
IVDeology and Management Forum have developed a highly interactive training programme to provide a deep-dive into the nine documents mandated in Annex XIII - Performance Evaluation, Performance Studies and Post-market Performance.
We shall answer what information is required, where to put it and when. The primary documents we will review are as follows:
- Performance Evaluation Plan
- Scientific Validity Report
- Analytical Performance Report
- Clinical Performance Study Plan
- Clinical Performance Study Report
- Clinical Performance Report
- Performance Evaluation Report
- Post-Market Performance Follow-up Plan
- Post-Market Performance Follow-up Report
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
Benefits of attending
- Gain a comprehensive overview of documents mandated within Annex XIII of the IVDR
- Enhance your understanding of key concepts used within IVDR performance evaluation
- Understand the purpose and scope of each document and their interrelationships
- Learn how to draft documents to assist Notified Body reviews
Who should attend?
Professionals involved in the research, development, or manufacturing of in vitro diagnostic medical devices, including:
- Senior management
- Regulatory affairs personnel
- Quality assurance professionals
- Product development personnel
- Project managers
- R&D personnel
- Clinical performance study personnel
- Pharmaceutical/CRO clinical trial managers
This course will cover:
IVDR Introduction
- Global overview of IVD Regulation
- Performance evaluation within IVDR
Performance evaluation plan (PEP)
- What is the purpose of the PEP
- Value to the manufacturer
- When should it be written
- What should it contain
Scientific validity report (SVR)
- What is the purpose of the SVR
- Value to the manufacturer
- When should it be written
- What should it contain
Clinical performance study plan (CPSP)
- IVDR versus ISO 20916
- The types of clinical performance study
- Clinical performance studies that require application to competent authorities
- What is required in a CPSP
Performance evaluation report (PER)
- What is the purpose of the Analytical performance report (APR), Clinical performance report (CPR) and PER
- Value to the manufacturer
- When should they be written
- What should they contain
Post-market performance follow-up (PMPF)
- What is it and how should it be used
- What would a PMPF plan contain
- Notified body expectations
Jane Leadsham
Ivdeology
Jane Leadsham is a IVD Medical Device professional with 10 years experience gained working in in vitro diagnostic Medical device development firstly for Novartis Pharmaceuticals, and currently as a consultant regulatory medical writer. Jane specializes in supporting IVD manufacturers to meet the performance evaluation requirements of (EU) IVD Regulation 2017/746.
Jane has held several senior R&D scientist roles for both an in vitro diagnostic manufacturer and a biotech company and completed a five-year post-doctoral research project at the University of Kent. This cross-sector industry/academia experience has provided Jane with a thorough but diverse knowledge of research, development and product commercialization.
As a consultant medical writer to the IVD industry, under the (EU) IVD Regulations 2017/746, Jane has worked on end-to-end projects, including with Notified Bodies, and successfully completed CE certification of a Class C IVD device. Jane has completed performance evaluation documents for:
- three CDx devices including preparation of documents required for interventional performance evaluation studies,
- legacy devices transitioning from IVDD to IVDR, Classes A to D, and
- new devices in Classes A to C,
- complete sample to result fully automated systems, and
- near-patient testing/point of care device
Jane has also provided training programs on the performance evaluation requirements of the (EU) IVD Regulation 2017/746 to five device manufacturers. One manufacturer, with a complex, near-patient testing, Class D device, used Jane to provide template documents and regular on-going training and support for staff to complete the performance evaluation documents themselves. Further, Jane has acted as a third-party reviewer for performance evaluation documents written by external contractors, including AI.
As a Principal Scientist, and member of a near-patient testing device development team, with Novartis Pharmaceuticals, Jane led a group of scientists in conjunction with a CRO to design, develop and manufacture a key component of a cardiac marker immunoassay within the target timeline. Jane was part of the team that planned and executed a prospective clinical trial to assess the performance of the near-patient device .
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
5 November 2024
Live online
09:30-16:15 UK (London) (UTC+00)
10:30-17:15 Paris (UTC+01)
04:30-11:15 New York (UTC-05)
Course code 15218
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 01 Oct
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
5 March 2025
Live online
09:30-16:15 UK (London) (UTC+00)
10:30-17:15 Paris (UTC+01)
04:30-11:15 New York (UTC-05)
Course code 15219
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 29 Jan
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
10 July 2025
Live online
09:30-16:15 UK (London) (UTC+01)
10:30-17:15 Paris (UTC+02)
04:30-11:15 New York (UTC-04)
Course code 15220
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 05 Jun
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
5 November 2025
Live online
09:30-16:15 UK (London) (UTC+00)
10:30-17:15 Paris (UTC+01)
04:30-11:15 New York (UTC-05)
Course code 15228
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 01 Oct
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
