MDR and IVDR regulatory information published by the HPRA

News Category: Regulatory news

Date: 23/11/2022

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:

• Clinical investigations,

• Medical device classification, and

• MDR transitional provisions.

2. The In Vitro Diagnostic Medical Devices Regulation (IVDR) including topics such as:

• Performance studies for IVDs,

• IVD classification, and

• European Union reference laboratories.

3. Common aspects of the Regulations including topics such as:

• Notified body designation and oversight,

• HPRA inspections, and

• Documents and guidance

This not an exhaustive list of topics covered. Please visit the Medical Devices Regulatory Information page for more information.

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