The MHRA has issued guidance on how the UK will register medical devices post-Brexit. All medical devices will need to be registered at the start of 2021, with grace periods depending on the classification.
By 2023, all devices to be sold in the UK will require a new UKCA marking to be distributed and sold in the UK markets. For companies already working through the challenge of the EU MDR, this adds to the regulatory burden with yet another filing requirement.
Regulators would ideally be closely aligned to EU MDR and CE marking requirements to minimize additional burden, though time will tell. In preparation for the autumn meeting with the life sciences, regulatory leaders should be in contact with the MHRA to help guide and shape the UKCA requirements and ensure it is both effective for quality and safety standards, yet does not create burden that stifles competition and innovation.
Post-Brexit guidance published by the MHRA states the UKCA mark will be required from July 2023.