News Category: Regulatory news
Regulation (EU) 2023/607 came into force on 20 March 2023. This Regulation extends the transitional provisions of the Medical Devices Regulation (MDR) for medical devices.
Why were the transitional provisions extended?
This extension gives more time to notified bodies and manufacturers to certify devices under the MDR. It aims to avoid disruption to the supply and availability of devices and health care in the EU.
Industry stakeholders should read and review this Regulation to understand how the extension may impact their organisation. You can find more information about the extension on our MDR transitional provisions webpage.
Does the extension apply to all Directive-compliant devices?
The extension will apply to a medical device if:
- it meets the specific criteria outlined in Regulation (EU) 2023/607.
- its certificate expires after 20 March 2023.
Where a device meets the specific criteria but its certificate expired before 20 March 2023, Irish-based manufacturers should email us at devices@hpra.ie.
Where can I find more information about the extension to MDR transitional provisions?
The EU Commission is currently developing a Q&A document which will give more practical information on the application of the extension. We will make this document available on our website once published. We will also send an alert to stakeholders who have signed up for HPRA web updates.