On 13 November, the Medical Device Coordination Group (MDCG) published their long anticipated IVD Classification guidance document for IVDR (MDCG 2020-16). The purpose of the document, “is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union. It is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution.” As with all guidance from the MDCG, it is meant to be read in conjunction with the In Vitro Diagnostic Regulation (IVDR). In short, this guidance document is very helpful in not only understanding the way to classify IVD devices in accordance to the IVDR, but also helping with justifying the right class for the IVD device.
In an effort to capture the essence of the guidance document, the following information will be useful to understand prior to your in depth review and application to your Notified Body.
- The MDCG has provided explicit examples of many IVD devices and their classifications under IVDR throughout the document.
- The importance of clearly defining the intended purpose of your IVD is prominently reiterated.
- Helpful clarification is provided around classifying combination of IVDs with accessories and combination of IVDs with IVD instruments.
- Guidance on classification and qualification of IVD software, in line with previously published guidance MDCG 2019-11.
- It may be possible for a device to fall under more than one indent. Where this is the case, the most appropriate indent should always be applied, based on the intended purpose of the device (Rule 3).
- When a device simultaneously detects a marker that falls under two different rules, leading to a different classification, then the highest class prevails for the whole device (Rule 4).
- Accessories are considered devices if they possess one or more specific characteristics to specifically enable an IVD to be used in accordance with its intended purpose or to assist the medical functionality of the IVD (Rule 5).
- If a laboratory instrument has an independent measuring function, which does not use any additional reagents, it is classified according to the intended purpose of the analysis (Rule 5).
- There are some “known unknowns” in the document that may lead to different interpretation by the stakeholders:
- Supplemental assays are not mentioned (although these are acknowledged in Rule 1, Rule 2 and Rule 3 in Annex VIII of the IVDR)
- The implication of the difference between the definition of transmissible agent and infective/infectious agents on the classification is not entirely clear
- Member states’ (varying) national legislation on blood safety testing could lead to a different classification among member states, or potential off-label use (Rule 1)
- The document could have borrowed more examples from the existing MEDDEV Medical Device Borderline and Classification document, since these are also applicable to the IVDR
In order to be acquainted with the state-of-the art in classification of IVDs, this document requires a thorough review by the manufacturer. Although the guidance states to be not legally binding, in practice, the document will have a big impact on the classification of IVD devices. With experience of classifying medical devices in accordance to the Medical Device Regulation (MDR), it is expected that deviating from the views captured in this MDCG document will certainly raise eyebrows with the EU Competent Authorities and Notified Bodies.
Recommendations to IVD Manufacturers
As you are preparing your technical file for submission to your Notified Body for CE Mark under IVDR, the following steps are essential:
- Review the guidance and determine if this affects the classification.
- If you cannot find your specific device with your intended purpose clearly defined in the examples, NAMSA can help to determine this.
As with any regulatory guidance, it is important to understand what is stated and that this guidance is not unique in that regard. The potential gaps that are highlighted here will hopefully become clear in the coming months in future publications by the European Commission. Additionally, MEDDEV 2.14/1 (IVD medical devices: Borderline Issues) published in 2012 may still be worth a look for situations not explicitly covered in this new guidance or the IVDR.
How NAMSA Can Help
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device and IVD development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for medical device and IVD manufacturers.
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Alex Laan has been in the IVD and Medical Device industry for a total of 20 years with 12 years spent working for a respectable EU Notified Body. Alex has held the position of Principal Certification Manager at DEKRA Certification BV, a Notified Body for IVDs and Medical Devices located in Arnhem, The Netherlands. Mr. Laan also worked for KEMA Quality, beginning in 2006, where he was qualified for Lead Assessor for Medical Devices and IVD devices, Device Specialist reviewer in IVDs and Medical Devices, including drug-device combinations. In these roles, Alex managed projects with large multinationals (e.g., Boston Scientific), as well as small start-up companies. Alex has been an active member of IVD working group within EU Notified Bodies and TEAM-NB and acting as direct contact for EU competent authorities and EMA on implementation of the EU IVDR (2017/746) and EU MDR (2017/745).