MDR certification for Agfa Class IIa solutions

Image source: Agfa HealthCare

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 data

Chris 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

08.09.2021

Read all latest stories

Related articles

Photo

Digital radiography

New from Agfa: SmartXR, Dura line and DSA

SmartXR is designed to make users' work easier and to support them in image acquisition, for example in aligning the DR detector, positioning the patient or setting optimal acquisition parameters.…

Photo

Agfa’s SmartXR

AI gives the digital radiography workflow a boost

In the move to evidence-based medicine, healthcare budgets put more pressure on efficiency, while quality of care has to meet ever increasing standards. Agfa has chosen to direct its development of…

Photo

Viewing through a ‘window’ empowers management

How to shape a blueprint for progress

Hospital data from a wide range of disciplines, departments and specialties strongly influences crucial decision-making and planning. Agfa HealthCare’s Business Intelligence solution, for example,…

Related products

Agfa HealthCare – Dose

Dose Management Systems

Agfa HealthCare – Dose

Agfa HealthCare
Agfa HealthCare – DR 100e

Mobile DR

Agfa HealthCare – DR 100e

Agfa HealthCare
Subscribe to Newsletter