Transitioning from the European Union's previous In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) is a challenging process for manufacturers. The IVDR introduces risk-class based devices and requires more rigorous documentation, clinical evidence and post-market surveillance, ultimately to ensure the safety, effectiveness and reliability of in vitro diagnostic devices.
The IVDR subjects high- and medium-risk devices to a conformity assessment procedure involving an independent third party: a Notified Body.
This webinar aims to provide manufacturers with an overview of the activities of Notified Bodies and the conformity assessment process, and market insights, to provide them with the information they need to ensure their devices can be placed on the market and comply with the IVDR’s higher standards.
Agenda
- The role of the Notified Body
- How to select your NB: intended purpose and classification
- Conformity assessment overview and sampling
- Market insights
- Application process overview and structured dialogue
- Q&A
Target Audience: This webinar is intended for in vitro diagnostic medical devices manufacturers worldwide, including corporations and SMEs, start-ups, persons responsible for regulatory compliance (PRRCs), EU authorized representatives, and regulatory affairs managers, quality managers, technical directors, R&D managers, validation managers and their teams.
Language: English
Cost: No charge
7, M. Eminescu Street,
Republic of Moldova,
Chisinau, Moldova