Medical devices legislation

In May 2021, the Medical Devices Regulation came into force, one year later than originally planned due to the COVID-19 pandemic. This new piece of legislation introduced new responsibilities for EMA, NCAs and notified bodies. For instance, EMA is responsible for the overall evaluation of marketing authorisation applications for medicinal products containing a medical device as an integral part, while notified bodies are responsible for the review of the relevant general safety and performance requirements of medical devices that form an integral combination with a medicine.

To help developers prepare for submissions to EMA, the guideline on quality documentation for medicinal products when used with a medical device was finalised and published in July 2021. The guideline applies where a medicinal product and a medical device form an integral product, where they are packaged together or where the product information of a medicinal product refers to a specific medical device it needs to be used with.

The Medical Devices Regulation was approved together with the Regulation on In-Vitro Diagnostic Devices, which will apply from 26 May 2022. 

The transition timelines were amended on the initiative of the European Commission in October 2021, also due to COVID-19. The original five-year transition period for different types of in-vitro diagnostic devices is now shorter for devices classified as higher risk (until May 2025) and longer for devices classified as lower risk (until May 2027). Before a notified body can issue a CE certificate for a companion diagnostic, it must seek a scientific opinion from EMA on the suitability of the diagnostic for the medicinal product concerned.