2 Jun 2021

Medical Devices Regulation

The Medical Devices Regulation (Regulation (EU) 2017/745) has become applicable on the 26th May 2021, following a four-year transition period.

Now, manufacturers must comply with this Regulation when placing a new medical device on the market.

Find out more at: https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

OWLPHARMA can help your company 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.