The new and stringent requirements related to clinical evidence has already created chaos among the industry. It necessitates the manufacturer to go through the existing evidence and ensure that it is in compliance with the new definitions and performance evaluation requirements set by IVDR.
Importantly, for classification rules and companion diagnostics guidance documents like MED DEVs from the Commission would really benefit the industry. Having all these challenges, effective from 27 May 2022, manufacturers without compliance to IVDR, may not be able to market their product in the European Union. At HCLTech, a wide pool of regulatory consultants are involved in providing their expert services to the industry to cater to the change within the required timeframe.