Notice to manufacturers to ensure timely compliance with mdr requirements.

MDCG published a Notice to manufacturers to ensure timely compliance with MDR requirements.

EU Medical Device Regulations

The EU Regulations entered into force in May 2017 following formal publication in the Official Journal of the European Union (OJ). To allow time for transition to the new requirements, the Regulations become fully applicable over a transition period. The MDR originally provided for a three-year transition period, however, due to the global outbreak of Covid-19, full application of the MDR had been extended and is fully applicable since 26 May 2021. 

With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has changed significantly.

The main objectives of these two regulations are to

“establish a robust, transparent, predictable and sustainable regulatory framework for medical devices and in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation”.