MDCG Guidance Document on IVD classification

If you're involved in the manufacture or sale of in vitro diagnostic medical devices (IVDs) in the European Union, you'll want to familiarize yourself with the MDCG guidance document on IVD classification. This document (second revision), developed by a group of experts representing Member State Competent Authorities, Commission services, notified bodies, and industry, provides guidance on how to classify an IVD prior to placing it on the market.

The guidance document covers the classification rules as set out under Annex VIII of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), as well as diagnostic or information society services performed on EU patients or devices put into service through distance sales. It also takes into account the Corrigendum published in the Official Journal of the European Union on 27 December 2019.

The primary purpose of the guidance document is to ensure the uniform application of the relevant regulatory provisions. It is intended to provide useful information for manufacturers, notified bodies, and health institutions on how to classify an IVD prior to placing it on the market. It also serves as a resource for regulators and other stakeholders when assessing the class attributed to an IVD. Examples in the document are provided for illustrative purposes only and do not represent an exhaustive list.

The guidance document should always be read in conjunction with the IVDR. By following the guidelines set out in the MDCG guidance document on IVD classification, you can ensure regulatory compliance and avoid potential issues down the line. This is particularly important given the legal empowerment for the classification of IVDs set out in the IVDR. 

The guidance document is an essential resource for anyone involved in the manufacture or sale of IVDs in the EU. In summary, the MDCG guidance document on IVD classification is an essential resource for anyone involved in the manufacture or sale of IVDs in the EU. 

By following the guidelines set out in the document, you can ensure regulatory compliance and avoid potential issues. Make sure to read the document in conjunction with the IVDR and refer to it whenever necessary.

Download the full article here: MDCG guidance document on IVD classification.

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