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) [7 mins]

Brief background on the regulatory environment, definition of an in-vitro diagnostic test (IVD) and an overview of the new regulatory framework in Europe including key dates.

Video 2: Product Classification and Conformity Assessment Routes [18 mins]

Product classification for diagnostic tests explained based on risk level and guide on how to carry out a conformity assessment. The conformity assessment route depends on the classification of the device.

Video 3: Product Design and Development  [36 mins]

From idea to finished article: product design and development. This video explains why test developers should complete an intended use and purpose statement at the beginning of product design and development. Test developers need to meet general safety and performance requirements when taking into account the products intended use. To place a product on the market it has to comply with the regulation when its used in accordance with your intended use.

Video 4: Performance Evaluation; Technical Documentation; Post-Market Responsibility; Placing on the market  [13 mins]

An overview on how to conduct performance evaluation; present technical documentation for the notified body; structure post-market feedback and surveillance plan for post-market responsibility; and present key players to safely place diagnostic products 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.