Continuing our series of publications, in this briefing we explore which EU Notified Bodies have been designated under the new Medical Devices and In-Vitro Devices Regulations, and the slow pace of approval despite increased demand for their services.
We also examine progress on the re-designation of the National Standards Authority of Ireland (NSAI), the only Irish Notified Body in the MedTech space, and the path to approval for medical devices under the new Regulations
Click here or on the image below to download this briefing, or click the following links to view the rest of our series:
- Act Now to be Ready on Time – Guide to New Classification Rules for In Vitro Diagnostic Medical Devices
We outline the key changes to the classification of in vitro diagnostic medical devices in advance of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) becoming fully applicable on 26 May 2022.
- Medical Devices – New Classification Rules – Is your Business Ready?
A guide to the classification of devices under the new Medical Devices Regulation
