UK RESPONSIBLE PERSON
We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.
Since Brexit, medical device companies must adjust to guidelines outlined by the Medicines & Healthcare products Regulatory Agency (MHRA). The guidance specifies that the representative in the UK will be termed the UK Responsible Person (UKRP). An UKPR must be appointed and must register the manufacturer, any relevant importers, and the devices with the MHRA.
The MHRA has postponed for 12 months the final date for acceptance of CE Marked devices on the UK market (June 30, 2023). That means CE Marked devices can be marketed in the UK past July 1, 2023. A transitional agreement will start in July 2024.
Please note that due to the recent EC decision (from February 2023) to extend deadlines of MDD certificates, the UK transitional agreement may be delayed as well, Stay tuned!
In June 2022, MHRA published the Government response to the consultation on the future regulation of medical devices in the United Kingdom MHRA MD Consultations.
BioReg services may include:
- Medical device in-country representation (UK Responsible Person)
- Brexit consulting strategy to align with UK Conformity Assessment mark
For more information, don’t hesitate to get in touch with us.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.