EU In Vitro Diagnostic Regulation (IVDR)

1-day course

The In Vitro Diagnostic Medical device directive has partially been replaced by the In Vitro Diagnostic Regulation. The transition period for regulation 2017/746 for IVD devices on the European market is postponed for some processes and some of the products but for other products it is required from 26th of May 2022. The new regulation will have a great impact on all device manufacturers, with stricter requirements on devices as well as on manufacturers’ QMS’s, throughout the product lifecycle.

QAdvis offers a 1-day course on the new regulation, to give you a basic understanding of the new requirements and help you get started on the transition project.

Topics

  • Key differences between IVDD and IVDR
  • Classification rules and conformity route
  • Time schedule – what is required when
  • Technical documentation requirements overview
  • General safety and performance requirements (GSPR)
  • Post-market surveillance
  • UDI and product labelling
  • Performance evaluation
  • Common specifications
  • Impact on quality management systems
  • Implementation timeline
  • Implementation plan
  • How to conduct a gap assessment

Target group
This course is intended for quality and regulatory professionals working with In Vitro Diagnostics, medical device company management and employees who need to learn more about the impact of the IVDR.

Educational goals
After the course, participants will have a basic understanding of the requirements of the new In Vitro Diagnostics Regulation (IVDR) and of its impact on all device manufacturers, with stricter requirements on devices as well as on manufacturers’ quality management systems, throughout the lifecycle of a product.

Recommended prior knowledge
The course has been developed for participants who have a basic knowledge of IVDD and ISO 13485.

Course presentations
Course material will be in English, verbal presentation and discussions in Swedish.

Printed course presentation, a printed spiral bound book of the IVDR Regulation (EU) 2017/746 is included only in our On-site courses. Online courses provide course presentation sent by email.

A short test and a certificate are included in all our courses.

Course Leader/s
Anna-Karin Areskog, Senior Quality and Regulatory Consultant

Dates and location

Lund
To be decided / On request

Stockholm
To be decided / On request

Online course
To be decided / On request

Prices
Onsite: SEK 6 900: –
Online: SEK 5 900:-

All prices excl. local VAT.

For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.

Customized training courses and seminars

We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.

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