At Galena Pharma our expertise is founded in the regulatory compliance of medical devices. Galena has been certified as a manufacturer under the European Medical Device Regulation 2017/745 (MDR) already since July 2022. Our expertise is substance-based medical devices and our selection consists of more than 50 diverse medical devices (class IIa and IIb), and the number is increasing rapidly.
Currently we are closely following the development of a new standard ISO 18969 Clinical evaluation of medical devices. The new ISO 18969 standard will serve as a guide for all aspects of the clinical evaluation for medical devices. The standard is much influenced by the EU-MDR but will be process oriented and comprehensive guidance that is applicable under any regulation.
ISO 18969 abstract: This document specifies terminology, principles and a process for the clinical evaluation of medical devices. The process described in this document aims to assist manufacturers of medical devices to estimate the clinical risks associated with a medical device and evaluate the acceptability of those risks in the light of the clinical benefits achieved when the device is used as intended.
The final revision of the standard is estimated to be ready in 2026. But it is anticipated that a version for which only administrative changes will be made, will be released at the end of 2025. We’re also following closely the progression of the new guidance on clinical evaluation by the MDCG, which should also be published soon.
We are excited to welcome the new clinical evaluation standard, which will enable us to serve our customers with even higher quality! As a customer of Galena Pharma, you can be sure that our devices and processes always comply with the latest standards and guidelines set for the medical devices.
Further Information:
Heidi Taipale, Director, Regulatory Affairs and Product Safety, PRRC
Johanna Tamminen, Regulatory Affairs Manager
firstname.lastname@galena.fi
Galena Pharma is a GMP- and EU MDR -certified pharmaceutical company specializing in manufacturing and developing substance-based medical devices. Galena Pharma provides its own ready-to-market MDR-approved medical devices for in-licensing as private label products. Our focus indication areas are gastrointestinal, female intimate care, cough & cold, pain and skin care.