MDR replaces the Medical Devices Directive (93/42/EEC) and brings more scrutiny of technical documentation; improves assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.
On 07/02/2020 Agfa received communication from FAGG (Federal Agency for Medicines and Health Products Belgium) that the notification dossier for hardcopy film and printer Class I products has been accepted by FAGG under new Regulation (EU) 2017/745.
This means that for these product lines Agfa is already compliant and ready for the application date of the EU MDR on 26/05/2020.
In total 70% of the Agfa Class I products have been accepted under EU MDR by FAGG.
Agfa is also on track to achieve MDR compliance for all Class IIa and IIb products, and provide business continuity towards its European customers.