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The MDR, or Medical Device Regulation 2017/745 is the latest set of regulations that govern medical devices in Europe.
Compliance with this Regulation is mandatory for medical device companies around the world that want to sell their products on the European market.
The Medical Devices Regulation (EU) 2017/745 entered into force in May 2017 and has officially replaced the Medical Device Directive (MDD 83/42 EEC).
The extent to which these changes will affect your company depends on the type of device manufactured and the role you hold in industry.
In most cases, whether you are a manufacturer, distributor or importer, significant changes must be made to the Quality Management System, and the technical documentation.
Details of services offered coming soon.
Contact us today if you require a consultant to help with updating your Quality Management System and / or Technical Documentation to align with the Medical Device Regulation 2017/745.