Freyr Ensures Swissmedic Compliance for a
UK-based Medical Device Manufacturer
Project Background
- Customer – A UK-based leading manufacturer of surgical devices.
- Device Category – Diabetic care Products.
- Service Offering- Swiss Authorized Representation (CH-REP) and Device Notification Services.
- Health Authority – Swissmedic.
Business Imperatives
- Well-established player in Switzerland.
- The client has Class IIa, Class IIb, and Class I devices being imported to Switzerland.
- Few devices are CE-certified under the EU MDD and others fall under the EU MDR.
- The client had a privilege of single market access till the Brexit, Swixit, and the expiration of Mutual Recognition Agreement (MRA).
- Post to Brexit and non-renewal of MRA (Swixit), the UK device manufacturer is considered a foreign manufacturer in the EU and Switzerland market.
- Need to appoint a Swiss AR within the applicable grace period.
- Almost 26 devices had to comply with the Swissmedic requirements.
- Quick Turn-Around-Time (TAT) for onboarding as well as notification of devices.
Challenges
- Different variants require separate listing.
- The grace period for Class IIa and Class IIb devices was two (02) weeks away.
Client Benefit Highlights
- Freyr is a registered CH-REP with Swissmedic and has a CHRN number.
- Freyr has all the necessary QMS in place required to act as a Swiss AR.
- Freyr was onboarded as a Swiss AR within three (03) working days.
- Freyr was appointed as a CH-REP for a manufacturer that was covering 26 devices. The devices were able to continue marketing within three (03) days.
- Hassle-free import of the devices without any business disruption.
- Support for labeling compliance.
Solution
- Preliminary due-diligence and categorization of devices into two (02) phases.
- Freyr was appointed as a Swiss AR within three (03) working days and immediate device registration was initiated.
- Thorough review of device technical file and other details for Medical Device Ordinance (MedDO) compliance.
- Successfully notified Swissmedic.
Phase I:
- Class IIa & Class IIb devices require compliance by March 31, 2022.
- Devices falling under 4 Global Medical Device Nomenclature (GMDN) codes and marketed under different brands.
- Each GMDN code had multiple branded devices falling under it.
Phase II:
- Eighteen (18) product variants of Class I devices under 2 GMDN codes had to comply with labeling requirements by July 31, 2022.
- Successful notification of all devices within the stipulated timeline.
