The EU Medical Device Regulation (EU MDR) has entered the full-year implementation phase, and IVDR (In Vitro Diagnostic Medical Device Regulation) will be formally implemented from May 2022. Although the transition time has been extended, the equipment to be evaluated will be reviewed after the implementation of IVDR, and a series of problems still exist. Prior to the new device classification standard issued by IVDR, only about 20% of in vitro diagnostic devices (IVDs) required mandatory conformity assessment by designated agencies, and now this ratio has increased to about 80%.

Although the number of designated certification bodies will increase in the second half of 2022, medical device and in vitro medical diagnostic device manufacturers will still face huge challenges, on the one hand from clinical (effect evaluation) requirements, on the other hand from market requirements.

As manufacturers adapt to EU regulations, they will begin to prepare for the UK Mandatory Conformity Standard in 2023, as all equipment and devices entering the UK market will need to meet this strong standard from June 2023 onwards.

The rapid transformation of marketing, sales, training and service into online mode not only provides more choices and convenience for clinicians and medical institutions, but also improves the efficiency of manufacturers. There is no doubt that specific free support services for hospitals and doctors will continue to exist (e. g. complex surgical support and equipment training). Many studies have shown that clinicians and sales representatives prefer virtual interactions, which can maintain customer data consistency, thereby enhancing customer relationships and improving customer satisfaction.

However, virtual interaction will put pressure on medical device manufacturers who are not "pioneers" of digital innovation, and promote them to establish a customer-centric digital marketing system to meet a series of customer sales, training, service, inventory management and other needs.