EU Manufacturer ensures
Post – Brexit UK MHRA Compliance

Project Background

  • Customer – France based medical device company specialized in Design and Manufacturing.
  • Device Category – Traumatology, Neurosurgery and Orthopedic surgery.
  • Service Offering- United Kingdom Responsible person (UKRP).
  • Health Authority – Medicines and Healthcare products Regulatory Agency (MHRA).

Business Imperatives

  • Well-established player in UK with in respective device market.
  • The client has Class III, Class IIb, Class IIa and Class I devices being exported to UK.
  • The devices are CE certified under EU MDD.
  • The client had a privilege of single market access till Brexit.
  • Post-Brexit, being a EU device manufacturer, is as foreign manufacturer.
  • Need to appoint a UKRP within grace period.
  • Almost 1000+ SKUs had to comply with the UK MHRA requirements.
  • The devices are of same risk class and had same GMDN codes.

Challenges

  • Different variants require separate listing.
  • High volume, 1000+ device products in scope.
  • The grace period for Class III devices and Class IIb implantable was 2 weeks away.

Client Benefit Highlights

  • Freyr registered as an UKRP with UK MHRA.
  • Freyr has all the necessary SOPs and Processes required to act as an UKRP.
  • Freyr is onboarded as an UKRP within 48 hours.
  • 245 devices are successfully registered with UK MHRA within a week’s time.
  • Hassle-free export of the devices without any business disruption.
  • Supported for importer registration, one stop shop for Medical device services.
  • Quick Turn-Around-Time (TAT) for onboarding and registration of the devices.

Solution

  • Preliminary due-diligence and categorization of devices into 3 phases.
  • Freyr appointed as UKRP in 48 hours and immediate initiation of device registrations.
  • Thorough review of device technical file and other details for UKMHRA compliance.
  • Details updated in bulk upload template and successfully listed in UK MHRA portal.

Phase I:

  • Class III & Class IIb implantable require compliance by 1st May 2021.
  • Devices falling under 4 GMDN codes and marketed under different brands.
  • Each GMDN code had multiple branded devices falling under it.
  • 5 importers were added.
  • Total of 245 variants registered within 2 weeks.

Phase II:

  • 18 product variants of Class IIa devices under 2 GMDN codes had to comply by 1st September 2021.
  • Updated bulk upload template is in effect from 20th August 2021
  • Successful registration of all devices before the date of new template was in effect.
  • 1 importer was added in Phase II.
  • Successfully registered all the devices within a week’s time.

Phase III:

  • Class I devices requiring UK MHRA compliance by 1st January 2022.
  • The third phase of the project is in progress.
  • Product details will be updated in the new template for UK MHRA submission.

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