Coding is an important consideration for CE certification of In Vitro Diagnostics (IVDs). Commission Implementing Regulation 2017/2185 established the codes for the designation of notified bodies in vitro diagnostic medical devices under Regulation (EU) 2017/746.
Join our webinar to learn about this coding system and how notified bodies use the codes to describe the individual qualification of the notified body personnel and the competences required for assessing a device. Our experts will explain why accurate coding is essential to support your CE certification application with us.
This webinar will explore the role and importance of coding under the IVDR, helping manufacturers understand how to streamline the conformity assessment process and maintain compliance with the regulation’s higher standards.
Agenda
- Introduction to IVDR coding and conformity assessment
- Commission implementing Regulation 2017/2185 and guidance
- IVR, IVS, IVT, IVP and IVD codes
- Significance and application of coding
- Application to a Notified Body and explanation of the sampling process
- Q&A
Target Audience
This webinar is designed for in vitro diagnostic medical device manufacturers worldwide, including corporations, SMEs and start-ups. It is particularly relevant for Persons Responsible for Regulatory Compliance (PRRCs), EU Authorized Representatives, regulatory affairs professionals, quality managers, technical directors, R&D managers and validation specialists – along with their respective teams.
Language: English
Cost: No Charge