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.
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.
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.
