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Importance of
MHRA Registration

Before any medical device or in vitro diagnostic device can be introduced to the UK market, it must undergo registration with the Medicines and Healthcare Products Regulatory Agency (MHRA). Compliance with the Medical Devices Regulations 2002 (UK MDR 2002) is mandatory for devices placed on the market and registered with the MHRA.
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Key Points to Note

  • Registration is accepted only for devices from manufacturers, UK Responsible Persons, or  Authorized Representatives based in Northern Ireland.
  •  Renewal of MHRA registration is required one year after initial application or confirmation,  followed by biennial renewals.
  • Failure to renew registration will lead to the removal of records from our database, affecting access to services.
  • A fresh registration application must be submitted thereafter to continue selling devices in the UK.

Essential Considerations for MHRA Registration

  • Notification to MHRA is mandatory before placing devices on the UK market.
  • Registration is required for manufacturers, sellers, renters, or lenders of:
  • Class I, IIa, IIb, or III devices (manufactured, refurbished, or re-labeled)
  • System or procedure packs containing medical devices
  • Custom-made devices
  •  In vitro diagnostics (IVDs) undergoing performance evaluation

Important for Non-UK Manufacturers:

  • Non-UK manufacturers must appoint a UK Responsible Person for registering items in the UK market from January 1, 2022.
  • Failure to register devices will render them ineligible for legal sale in the United Kingdom.

The UK MHRA Medical and IVD Device Approval Process Overview

  • Classification of Medical Device: The initial step is to classify the device according to MHRA’s rule.
  • Identification of Conformity Assessment Route: It is decided based on device classification and after that Implementation of a compliant Quality Management System takes place (which adheres to EN ISO 13485 standards)
  • Preparation of Technical Files: According to device classification, file preparation takes place. For those classifications that require certification from the UK Approved Body , they have to engage UKAB [United Kingdom Approved Body] & submit the technical file or design dossier for review. Upon approval, the UKAB issues the UKCA [United Kingdom Conformity Assesed ] marking certificate respectively.
  • Engage with UKRP (United Kingdom Responsible Person): and, if necessary, a UK importer.
  • Conformity Declaration: After the creation of the Declaration of Conformity, UKCA is prepared and affixed.
  • Device Registration: The UKRP registers the device in MHRA DORS [Device Online Registration System] & application fee is submitted. The MHRA After review, can request more information if required.
  • Approval and Confirmation:After the approval by MHRA,a registration confirmation letter is issued for the device.