EU Notified Bodies are lagging in MDR designation

With the implementation date of EU MDR fast approaching (2020) for all Class 1-3 devices, notified bodies are having a difficult time meeting and receiving MDR designation status. The European Union projected that 20 notified bodies would become MDR designated by 2020, but only eight have been designated to date.

Class 1 devices often carry markedly reduced risk (i.e. tongue depressors are Class 1). Given their lower risk and suboptimal number of notified bodies being ready for MDR implementation, the EU has implemented a 4-year delay for some Class 1 devices.

This decision by the European Union while alleviating stress upon Class 1 device manufactures, allows notified bodies to focus their efforts on higher risk Class 2 (a and b) and 3 devices.

To learn more about the MDR remediation services offered by RNB Ventures Consulting, please contact the author at robert@RNBVenturesConsulting.com