We are delighted to announce that Galena Pharma is officially certified under the new European Medical Device Regulation (MDR) by Eurofins Electric & Electronics Finland Oy (0537) on 1 July 2022.
What does EU MDR mean to us?
According to Heidi Taipale, Director of Regulatory Affairs and R&D, receiving this certificate represents a significant step in Galena Pharma’s progression in the field of pharmaceuticals and health products since it positions Galena as one of the first companies in Finland—in the medical device sector—to earn this recognition. We are proud of this achievement! We can now continue supporting our clients as an EU MDR compliant manufacturer acting on their behalf and upgrading the technical dossiers of medical devices according to MDR requirements.
Galena is working intensively on three main objectives of the new medical device regulation; improving the overall health and safety level of medical devices, continuously enhancing the free trade of medical devices in the EU, and ensuring that products we are developing and manufacturing are with the current state-of-the-art technology and scientific knowledge, affirms Heidi.
Galena Pharma specializes in the complete lifecycle service of medical devices providing end-to-end solutions. The operations currently cover the design, manufacture, final inspection, and sales of the following types of medical devices:
- Gastrointestinal gas suppressants
- Skin moisture barrier dressings
- Wound cleaning solutions
- Stool softener
- Lactic acid-based products for vaginal mucosa protection
- Oils for dry and irritated vaginal mucosa
- Ointments for damaged skin
Galena Pharma´s assortment consists of more than 30 diverse medical devices (class IIa and IIb), and the number is increasing rapidly. All medical devices to which Galena Pharma acts as a manufacturer will be MDR-certified before the expiry of the respective MDD certification.
About Medical Device Regulation (MDR)
The Regulation (EU) 2017/745 on medical devices (“Medical Device Regulation” or “MDR”) entered into force already in May 2017 and was to apply on 26 May 2020. However, with graduated transitional periods coupled with further delay due to the COVID-19 pandemic, it got postponed to 26 May 2021. The last day to sell products under MDD certification is May 2025.
The core of the MDR is to guarantee patient safety. The new regulation comes with stricter guidelines than the previous directive, thus ensuring reinforced risk management through enhanced security and reliability of medical devices. Through the updated provisions in the MDR, the focus shifts from just approving the device to evaluating the device throughout its entire life cycle.
The MDR replaces the introductory EU Medical Device Directive (93/42/EEC).
Our experts will be happy to discuss your queries and help you upgrade your medical devices.
Heidi Taipale
Head of Regulatory Affairs and R&D, PRRC
heidi.taipale (at) galena.fi