Image source: Agfa HealthCare
News • Medical Device Regulation
MDR certification for Agfa Class IIa solutions
Agfa HealthCare is proud to be one of the first companies to receive the new European Medical Device Regulation (MDR) certification, which was issued by Intertek on 25 August 2021.
This certification, which covers Agfa HealthCare’s Class IIa Enterprise Imaging and Xero Viewer solutions, ensures that Agfa HealthCare can continue to deliver to customers innovative solutions that meet their real challenges and address their needs and requirements.
The MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive (93/42/EEC), and includes more stringent standards and requirements in both clinical and post-market areas. The new Regulation is intended to create a robust, transparent, sustainable and internationally recognized regulatory framework for improved clinical safety and fair market access for manufacturers. The MDR ensures alignment among European member states, and is applicable for the entire lifecycle of the products and the processes supporting the solution delivery.
Our early MDR certification is an acknowledgement of the strength of our life-cycle approach to safety, backed by clinical dataChris Ball
Agfa HealthCare’s early certification allows the company to continue to expand the Enterprise Imaging platform, its modules and components, and release innovations without any interruption. This includes making significant changes to the solutions and adding new functionalities to meet the evolving needs of our customers and the market, as well as allowing them to benefit from state-of-the-art IT technologies.
Chris Ball, Head of Quality Assurance and Regulatory Affairs, comments, “Agfa HealthCare is compliant with the latest and most rigorous quality standards and certification requirements for medical devices in the world, and MDR certification will be an important qualification criterion. Supported by our clinical evaluation, risk management and quality management systems, our early MDR certification is an acknowledgement of the strength of our life-cycle approach to safety, backed by clinical data.”
“The early certification offers clear proof that Agfa HealthCare is committed and ready to be the long-term partner of choice to our customers,” says Luc Thijs, President of Agfa HealthCare.
Source: Agfa HealthCare