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 significantly changed. 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.
Six years have passed since the adoption of MDR and IVDR and the implementation of the regulations is advancing. The Regulations’ transitional provisions have been amended to give manufacturers and notified bodies more time to conduct the necessary conformity assessment procedures and to avert shortages of devices needed for the EU healthcare systems.
Enhancing the capacity of notified bodies and the efficiency of conformity assessment procedures remain a top priority for the MDCG. The actions listed in MDCG 2022-14 are showing good results, e.g. use of hybrid audits, deferral of re-assessment of notified bodies and clarification of the meaning of ‘personnel employed by the notified body’ in Article 36 (1) MDR / Article 32 (1) IVDR. The MDCG remains fully committed to pursue the implementation of the actions listed in MDCG 2022-14 and calls for the continued full commitment of other actors involved, including notified bodies and industry.