EC: Template for Notified Bodies
On 24 May 2023, the European Commission provided a downloadable template that notified bodies can use under Regulation (EU) 2023/607.
Notified bodies may use it to confirm the status of the medical devices that are transitioning to the new regulatory framework of the MDR.
During the extended transition period to the Medical Device Regulation (MDR), medical devices with certificates issued according to the old regulations can remain on the market until 2026 or 2028, depending on their risk classification. To do so, manufacturers may need to demonstrate that their devices are subject to an open MDR application or are monitored by a notified body.
The 5-page template includes two tables for:
- devices for which an MDR application has been submitted, a written agreement has been established, and appropriate monitoring has been put in place.
- products for which an MDR application has been received and an agreement has been made, but for which no monitoring is in place.
The amending Regulation (EU) 2023/607 entered into force on 20 March 2023.
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