Presented by
Management Forum
Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746) Training Course
Understand the essentials of performance evaluation under the In Vitro Diagnostic Regulation (2017/746) in this comprehensive seminar. Essential for regulatory compliance and business success.
4 November 2024
+ 4 March 2025, 9 July 2025, 4 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.
This training will provide attendees with a holistic high-level view of performance evaluation, how it sits within the wider Regulation, the vital issues your organisation needs to understand to produce the relevant evidence within the terms of the new Regulation, the importance of establishing the cross-functional team needed within your organization to meet this new and demanding regulation and the role and interaction with the new Notified Bodies. It will then go on to consider the complex implications of the Regulation for overlap with the Clinical Trial Regulation (CTR) 536/2014 and Medical Device Regulation (MDR) 2017/745.
IVDeology and Management Forum have developed this training programme to provide detailed knowledge and understanding of the heavily updated area of performance evaluation within this vital new regulation and its opportunities and threats for your business.
Special offer:
Compliment your learning with our 'Deep Dive into the IVDR Annex XIII' course. This interactive training explores the nine essential documents mandated in Annex XIII, providing critical insights into performance evaluation, studies, and post-market performance requirements.
Sign up for both and get the second course at 50% off. Please contact us at info@ipi.academy to take advantage of this offer.
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 performance evaluation within IVDR
- Enhance your understanding of what performance evaluation means in the context of the new European Regulation
- Understand the complex IVDR processes and their inter-relationships
- Learn how to implement the IVDR in conjunction with Notified Bodies
- Scope key timelines and embrace practical considerations to support delivery
- Takeaway deliverables and actions for your company
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
- Clinical performance study personnel
This course will cover:
Introduction to in vitro Diagnostic Regulation
- Structure of the regulation
- Key sections relevant for performance evaluation
- Overlap with the CTR (536/2014) and MDR (2017/745)
- Notified bodies
- What has changed?
System failures and key drivers for change
- Main drivers for change
- Regulatory failures
- Scale of change
Intended purpose and risk-based classification
- Intended purpose/use
- Risk-based device classification
- Software
Performance evaluation and evidence collection
- Performance evaluation
- Clinical evidence
- Post-market surveillance
Key timelines and practical considerations for your company
- Timelines for clinical performance study approvals
- Notified bodies
- The EU dashboard
Actions for your company in delivering performance evaluation compliance under the IVDR
- Takeaway deliverables and actions for your company
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
4 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 15214
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 30 Sep
- 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
4 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 15215
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 28 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
9 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 15216
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 04 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
4 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 15217
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 30 Sep
- 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.
