We are pleased to announce that Biofaktor Sp. z o.o. has successfully completed the certification process and obtained the MDR certificate, in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. The certification applies to products classified as Class IIb.
The certificate was issued by TÜV Rheinland (0197), one of the most renowned and stringent notified bodies in the world. The scope of certification covers medical devices in the fields of proctology and women’s intimate health, including:
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rectal suppositories with hyaluronic acid,
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vaginal ovules with hyaluronic acid and lactic acid.
What does MDR certification mean? The new European Medical Device Regulation (MDR) imposes significantly higher requirements on manufacturers, particularly regarding Technical Documentation, clinical evaluation, and post-market surveillance.
Obtaining the MDR certificate is an independent and objective confirmation of the highest quality, safety, and efficacy of our medical devices. This marks another crucial step in the growth strategy of BIOFAKTOR. For our commercial partners and distributors, it serves as a guarantee that we deliver stable, safe, and modern solutions that meet the strict criteria of the medical market.