Medical Devices

On the 5th April 2017, 2 new regulations on medical devices and in-vitro diagnostic medical devices were adopted by the EU. They entered into force on 25 May 2017 and will progressively replace the existing directives.

At Pharmaconsulta, we can upgrade your QMS and audit your products for compliance to the new medical device regulations (MDR) as per Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR) which replace the three existing medical device Directives (93/42/EEC, 98/79/EC and 90/385/EEC).