How to bring IVDs to market in Europe - a guide to new EU Regulations

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, the following 1 hour course was recorded in Mumbai at a Longitude Prize workshop and has now been made available online.

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 as below.

Video 1: Regulatory background and definition of an in-vitro diagnostic (IVD)

Video 2: Product Classification and Conformity Assessment Routes

Video 3: Product Design and Development

Video 4: Performance Evaluation; Technical Documentation; Post-Market Responsibility; Placing on the market

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.