News Category: Regulatory news
We have published a new website section, which provides information in one central location on the Medical Devices Regulation and the In Vitro Diagnostics Regulation. The information is relevant to industry stakeholders, including manufacturers, authorised representatives, importers and distributors working to implement the Regulations.
The new website section includes newly published guidance on a number of key topics and collates previously published topics together for ease of reference. The new structure aims to make it easier for stakeholders to navigate and locate our regulatory information.
The topics on the page cover the following areas:
1. The Medical Devices Regulation (MDR) including topics such as:
2. The In Vitro Diagnostic Medical Devices Regulation (IVDR) including topics such as:
3. Common aspects of the Regulations including topics such as:
This not an exhaustive list of topics covered. Please visit the Medical Devices Regulatory Information page for more information.
We’re committed to working closely with stakeholders to facilitate compliance with the Regulations. We encourage engagement from all stakeholders. If you have any queries or feedback on the new website updates, please email us at firstname.lastname@example.org.