14 Oct 2021

Guidance on Medical Device classification under Medical Devices Regulation

Guidance on Medical Device classification, under Medical Devices Regulation (Regulation (EU) 2017/745), has been published by the Medical Devices Coordination Group (MDCG).

The purpose of the document is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements and clarify how to use the classification rules, with practical examples.

OWLPHARMA can help your company in medical device classification and to be in compliance with the new regulation, whether it be with the implementation of ISO 13485:2016 Medical Devices Standard or by performing audits in the scope of this standard.

Reach us at owlpharma@owlpharma.pt to know more about these services.