As you will be aware from previous blog posts, the new EU Medical Devices Regulations (the MDR and IVDR) will be applicable in May 2020 (for medical devices) and May 2022 (for in vitro diagnostic medical devices). The European Commission and medical device coordination group (MDCG) are busy preparing the guidance documents and implementing legislation to ensure the Regulations can function. Notified bodies are also going through the designation procedure to ensure they can accept applications under the MDR and that products can be placed on the market under the new Regulations. However, there is still much to do, and progress has been slow. We set out below an update on the current state of play.
Apologies that it has been a while since we’ve posted! We have lots in the pipeline, starting with this webinar.
Data and Its Impact on Medical Technology Companies Doing Business in the EU
Today’s medical technology industry is being transformed by data—clinical data, vigilance data, real world data and personal data. As such, there is…