Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK). On June 26th 2022, the outcome of this consultation was published.
This document describes the transitional arrangements for in vitro diagnostic medical devices (IVDs) to be placed on the UK market after July 1st 2023. Further, input is provided on the updated definition and scope, the amended classification system to be rule based similar in concept to the IVDR classification structure, in-house tests, economic operators, device labelling, designation of notified bodies and clinical evidence.
What does this mean to you?
Although we do not yet have the formal Regulations, this consultation outcome gives clarity on how to begin with making sure your products and organisations will be compliant to the new Regulatory structure in the UK.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
