BPR Medical is proud to announce that its medical devices have successfully achieved CE Certification under the European Union Medical Device Regulation (EU MDR) 2017/745.
The EU MDR sets a significantly enhanced standard for medical device safety, clinical evaluation, risk management, and post-market surveillance. Achieving certification under this regulation reflects BPR Medical’s strong quality management systems, robust technical documentation, and ongoing commitment to regulatory excellence.
This milestone ensures continued compliance within the European market while reinforcing the company’s dedication to delivering safe, effective, and reliable medical technologies to healthcare providers and patients.
The certification process required extensive cross-functional collaboration, rigorous review procedures, and detailed clinical and regulatory assessment. The achievement stands as a testament to the expertise, diligence, and perseverance of teams across the organisation.
Ben Johnson, Technical Director said, “Achieving CE Certification under the EU MDR 2017/745 is a significant accomplishment for BPR Medical. It reflects the dedication of our teams and our unwavering commitment to quality, safety, and regulatory compliance. We are proud to continue supporting healthcare professionals with trusted medical device solutions that meet the highest European standards.”
BPR Medical extends its sincere thanks to everyone involved in reaching this important milestone. As regulatory landscapes continue to evolve, the company remains focused on maintaining the highest standards of compliance while driving innovation to support healthcare worldwide.
