NKB Regovanta streamlines the entire UK MHRA medical device registration journey. We expertly verify your technical documentation and manage the submission process through the MHRA’s Device Online Registration System (DORS). Acting as your mandated UK Responsible Person (UKRP), we interface directly with the MHRA, handling registrations and vigilance obligations to guarantee continuous post-market compliance.
Ensuring Seamless Compliance for UK Medical Device Regulations
Foreign device manufacturers must adhere strictly to the UK Medical Devices Regulations 2002 (and subsequent amendments). It is a legal prerequisite that all medical devices and in vitro diagnostics (IVDs) be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) prior to commercialization in the UK market.
For manufacturers based outside the UK, appointing a local UK Responsible Person (UKRP) is mandatory. The MHRA enforces rigorous standards regarding technical documentation, product labeling, and post-market vigilance to safeguard patient health and ensure robust product traceability.
Navigating Post-Brexit Complexity
Understanding the latest regulatory shifts—including the nuances of UKCA marking, expanded clinical data expectations, and heightened post-market surveillance—can be daunting. Organizations frequently encounter roadblocks related to misaligned device classifications, incomplete Technical Files, and the intricacies of the Device Online Registration System (DORS). Constant updates to MHRA guidance further challenge strategic planning and resource management.
How NKB Regovanta Accelerates Market Access:
End-to-end management of DORS submissions
Dedicated UK Responsible Person (UKRP) representation
