EU Regulations for IVD
The winning Longitude Prize test must be available on the UK market. To aid competitors in preparing for the registration of their products under the new European Regulations, a one-hour course was recorded in Mumbai at a Longitude Prize workshop.
The video modules feature regulatory expert, Dr Gill Morgan from Sestria Limited, who presents an overview on the new European Regulatory Framework for in-vitro diagnostics (IVDs) and details what is required to bring a product to market in Europe.
For ease of use, we have broken down the course into four shorter modules:
- Module 1: Regulatory background and definition of an in-vitro diagnostic (IVD) [7 mins]
- Module 2: Product Classification and Conformity Assessment Routes [18 mins]
- Module 3: Product Design and Development [36 mins]
- Module 4: Performance Evaluation; Technical Documentation; Post Market Responsibility; Placing on the market [13 mins]
Dr Gill Morgan, Sestria Limited originally presented ‘IVD regulation in the EU’ for Longitude Prize competitors in India on 7 December 2018, Mumbai at the BIRAC Longitude Prize Accelerator programme. Original slides.