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.

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