The MDCG has endorsed a guidance (updated September 2022) providing clarification on the conditions and corresponding procedures notified bodies need to apply when determining if an expert panel consultation on the performance evaluation report of the manufacturer is necessary for a class D in vitro diagnostic medical device, according to Article 48(6) of Regulation (EU) 2017/746.
According to the IVDR, the conditions are:
- The absence of common specifications for the class D device in question, AND
- If it is also the first certification for that type of device.
Based on the above, the guidance analyses some key questions:
1. What is the meaning of “the first certification for that type of device” in accordance with Article 48(6) of Regulation (EU) 2017/746?
It means that notified bodies should consult the expert panels only where there is no similar device on the market with the same intended purpose and based on a similar technology and it is the first certification of that specific type of device under either Directive 98/79/EC or Regulation (EU) 2017/746, taking into consideration a specific:
a. Intended purpose, including everything listed below:
- What is detected and/or measured;
- The function of the device such as screening, monitoring, diagnostic, etc.;
- The specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate;
- Whether it is automated or not;
- Whether it is qualitative, semi-quantitative or quantitative;
- The type of specimen(s) required;
- Where applicable, the testing population;
- Intended user;
b. Analysis technology and process used, including:
- The principle of the assay method or the principle of operation of the instrument. (MDCG, 2021)
Considering the elements listed above, when a device with a specific set of those elements is certified under either Directive 98/79/EC or Regulation (EU) 2017/746, all the other devices with a similar set of elements to be certified for the first time under Regulation (EU) 2017/746, will be qualified as the same “type of device” independent of the manufacturer, and therefore an expert panel consultation won’t be necessary.
2. What procedure should a notified body follow to determine whether a given certification is the first for that type of device?
It is the responsibility of a notified body to decide whether the certification of the device in question can be considered as a first certification of its type, as well as documenting its assessment and corresponding conclusion. The notified body should consider the following elements for its decision:
- Its own knowledge and expertise;
- Information and relevant research provided by the manufacturer;
- Information on type of device for the already completed and ongoing consultations of the expert panel considered in question 3.
If the assessment concludes that no device of that specific type has been certified yet and no common specifications are available, the notified body will have to consult the expert panel.
3. How should the notified body indicate the type of device in its submission to the IVD expert panel?
When submitting the documents to the Secretariat, the notified body should provide the information requested in the template included in the guidance. Once filled in, the template will be published on the website of the expert panel for its ongoing consultations and then included in the views once issued.
4. What is the meaning of the phrase “where no CS are available” in Art 48(6)?
It means that there are no available common specifications adopted and published in the Official Journal of the European Union for that type of device. Only once the CS are published, they are considered “available” and therefore the expert panel consultation is not required.
5. If a notified body identifies that a consultation of an expert panel is currently ongoing for that type of device, what should it do regarding the certification process?
If a consultation is ongoing, it implies that the notified body is not dealing with a first certification. In any case, it should wait until the ongoing consultation is completed and the views are published, as it is highly recommended to take these into consideration when deciding on the issuance of the certificate.
You can find the text of the MDCG Guidance in our MDlaw Library – MDCG and NOTIFIED BODY.
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