In a significant regulatory milestone, Ypsomed has received the UKCA certification for the ServoPen and ServoPen Fix. The reusable pen injectors – developed for the administration of Apomorphine and RGB-10 (biosimilar teriparatide) – are now approved for continued distribution in the United Kingdom, ensuring patient access beyond the EU regulatory framework.
ServoPen and ServoPen Fix Certified for Post-Brexit Market
Following the UK’s departure from the European Union, the UK Conformity Assessed (UKCA) marking became a mandatory requirement for medical devices distributed in Great Britain. Thanks to a streamlined approach leveraging existing EU MDR documentation, Ypsomed completed the UKCA certification for ServoPen and ServoPen Fix swiftly and without complications. The initial certificate was issued in January 2025, setting the stage for uninterrupted product availability.
This certification demonstrates our ability to navigate complex regulatory transitions with agility, ensuring continuity of care for patients and confidence for our partners,
says Frank Schiffmann, Head of Product Area Pens at Ypsomed.
Foundation for Future Approvals
The successful UK approval of ServoPen and ServoPen Fix creates a regulatory pathway for additional products. With foundational documentation already in place, extensions to the UKCA certification can be achieved with minimal additional effort. In other words: This submission sets the milestone for further ServoPen and ServoPen Fix applications within the UK.
Collaboration Across Teams
This milestone reflects effective cross-functional collaboration between Regulatory Affairs, Product Management, and Quality Assurance teams. It highlights Ypsomed’s commitment to maintaining access to essential drug delivery platforms, regardless of evolving regional requirements.
