Based in the US, our client was a orthopaedic company that develops and distributes speciality instruments and implants.
A well-established player in the UK market, the client was exporting Class I, Class IIa and Class IIb devices to the UK pre-Brexit, CE-certified under EU MDD.
Post-Brexit, as a US medical device manufacturer the client appointed a European authorised representative (EC Rep) and needed to appoint a UK Responsible Person within the grace period to continue supplying the UK market.
More than 6,500 SKU (Stock Keeping Units) needed to comply with UK MHRA requirements. Devices had 50-plus different GMDN codes.
Objective
As the appointed UK Responsible Person (UKRP) liaising with the UK Medicines and Healthcare products Regulatory Agency (MHRA), our goal was to provide a seamless service that prevented any disruption to the business, process a high volume of device products with different variants requiring separate listings.
Solution
Registration of the devices was completed in three phases, with initiation of device registration beginning within 48 hours of appointment as UKRP.
Details were updated to and successfully listed in the UK MHRA portal using a bulk upload template.
Full registration with the UK MHRA of all medical devices was completed within a one-to-two week window of each phase of registrations.
Results
Phase I
Class IIb implantable devices required compliance by May 1, 2021. Devices fell under 10 GMDN codes and were marketed under different brands.
Each GMDN code had multiple branded devices falling under it. A total of 5,715 variants registered within a two-week period.
Phase II
360 product variants of Class IIa medical devices under 13 GMDN codes were successfully registered ahead of the September 1, 2021 deadline.
The registration was completed within five working days.
Phase III
565 product variants of Class I medical devices under 35 GMDN codes were successfully registered ahead of the January 1, 2022 deadline.
The registration was completed within five working days.
If you would like to speak to our team to discuss our UK responsible service, please enquire here.