In Vitro Diagnostic Regulation 2017/746
*Limited Places* UK Live Online Training (GMT)
- Started 21 JunStarted 21 Jun
- 895 British pounds£895
- Online Virtual Classroom
The IVDR will replace the current EU Directive on in Vitro Diagnostic Medical Devices (98/79/EC) and will be effective in all EU member and EFTA states. Our industry leading experts have created this 2-day course to give you an appreciation for the changes and new requirements of the IVDR and provide practical skills and guidance on how to transition to the new regulation. Course Agenda Module One - Reasons for the IVDR - Structure and key changes of the IVDR - Key terminology and definitions - Introduction to CE Marking Module Two - Placing a device on the market - Manufacturer’s articles & obligations - Economic Operator & PRRC Responsibilities - Declaration of conformity Module Three - Overview and structure of the classifications Annex VI - Class Types & Classification Rules - The General Safety and Performance Requirements Module Four - Routes to conformity - Notified Bodies - UDI - Overview of Eudamed Module Five - Clinical evidence - Performance evaluation and performance studies - Overview of scientific validity - Overview of analytical performance - Overview of clinical performance Module Six - Post-market performance follow-up - Post market surveillance - plan, report & period safety update report - Summary of safety and performance - Vigilance - Technical documentation - Transition timelines - Guidance Who should attend? This training course is recommended for anyone making and selling In vitro diagnostic devices into the European Union: - Regulatory Affairs Professionals - Research and Design Engineers - Quality Managers - Quality Engineers - Authorised Representatives - Consultants At a glance: - 2-days of interactive training - Instructor-led virtual classroom - Certificate of completion - Q&A session - Copies of the slides and handouts - 15% off the IVDR Guidebook - On-site training available on request Discounts are available for 3+ attendees. Please email us at firstname.lastname@example.org for your unique discount code to use at the checkout.
Places are non-refundable. Substitutions may be made at any time at no additional charge.
Meddev Solutions, 30 Monaghan Street, Newry Co. Down, BT35 6AA, N.Ireland GBR