The MDCG published a very important document for all IVD manufacturers, as well as for notified bodies and health institutions, which shall provide guidance on the classification rules under the IVDR – Regulation (EU) 2017/746, namely its Annex VIII – while noting that the regulatory text and the MDCG Guidance shall be read jointly.
Moreover, the MDCG underlines that this Guidance also applies to diagnostic or information society services performed on EU patients or devices put in to service through distance sales.
It is also stated that the Regulation sets out a legal empowerment for the classification of IVDs, and only in specific cases (envisaged by the Article 47.3 – 47.5. of the IVDR), the European Commission can decide on the application of Annex VIII of the IVDR for ex. to determine the classification of a specific device or address divergent interpretations through implementing acts.
The 44-page Guidance document firstly presents 16 definitions, such as first-line device, devices for monitoring, life-threatening, specimen, analyte, transmissible agent,… which are not specifically defined by the Regulation itself.
Secondly, the principles of classification are recalled: ” devices shall be classified into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks (Article 47)”. The class-dependence on the conformity assessment of an IVD (involvement of EU reference laboratories for high-risk devices) and post-market surveillance obligations are reinstated.
The richest section of the Guidance starts at page 8, entitled Explanation of the IVDR classification rules, including the rationale and practical examples of IVDs per each classification rule under the Annex VIII of the IVDR. An example below:
Source of the image: Taken from the MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.
Final pages of the Guidance cover the Examples of classifying IVDs used in combination:
- Enzyme-linked immunosorbent assay (ELISA) and analyser; where the analyser and its software are intended to run the assay and measure the output.
- Blood Gas Analyser and associated devices
It is important to note that the rationale and examples within the Guidance do not represent an exhaustive list, and are laid down for illustrative purposes.