Agfa HealthCare has received European medical device regulation (MDR) certification for its class IIA enterprise imaging and xero universal image viewer.
The MDR certification (Regulation [EU] 2017/745) recently replaced the former European medical device directive (93/42/EEC). The new certification includes more stringent standards and requirements in both clinical and postmarket areas in the hopes of improving safety and fair market access for manufacturers, according to Agfa. It also ensures alignment among European Union member states, the vendor added.
