On November 13, 2020, the Medical Device Coordination Group (MDCG) published a Guidance on Classification Rule for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 with the aim to help manufacturers, Competent Authorities, notified bodies and stakeholders to uniformly apply the classification rules stated in the new regulatory framework.
The document was written by MDCG experts representing EU Member State Competent Authorities, the European Commission, and the medical devices industry. Since only the EU Court of Justice can officially interpret EU law, the MDCG Guidance’s content is not legally binding; nevertheless, it provides crucial classification guidelines to the medical device community.
Devices’ Intended Purpose and Inherent Risks
In accordance with Regulation (EU) 2017/476, In-vitro diagnostics medical devices (IVD) will be classified in four classes (A, B, C and D) from lowest to highest risk, following the principles of:
– Intended purpose of the device and
– Device’s inherent risks for patients and public health.
The device’s intended purpose is the one specified by the manufacturer on the label, in the IFUs or in any other sales material, and it is the manufacturer itself that has to clearly limit said purpose in case the IVD device might be used for something that falls into a higher risks class. ‘’Ambiguous claims may lead to higher classification’’ (MDCG,2020).
The intended purpose determines the device’s inherent risks, and the two, combined, define the classification, which, in turn, regulates the conformity assessment route and the post-market surveillance requirements applicable to each device.
Only class A IVDs will be self-certified, all other devices will need the approval of a Notified Body; and class C and D IVDs will be subjected to annual surveillance assessments. Considering the above, a correct classification is the first step to compliance.
7 classification rules are stated in Annex VIII to the IVDR and the MDCG Guidance provides explanation and examples for each one of them. Regarding to combination of devices and accessories, classification rules should be applied separately to each one of the devices. Moreover, the Guidance presents definitions not included in the IVDR, such as ‘device for screening’, ‘life-threatening’, ‘transmissible agent’, etc.
It is time for manufacturers to reclassify their In-vitro diagnostics devices under the IVDR and this guidance will be of great help. In the future – in case of divergent interpretations or practical application issues – the EU Commission might adopt implementing acts, but, at the moment, the IVDR, read in conjunction with said guidance, is the most complete document we have.
MedTech Europe’s proposal for IVD symbols under the IVDR
According to Article 10.10 and Annex I Section 20 of the Regulation (EU) 2017/476, devices intended for self-testing, for near-patient testing and certain rapid tests will require to clearly state on their labels their intended user and setting.
Therefore, MedTech Europe (2020) – the European trade association representing medical technologies industry – has proposed some symbols that can be used for this purpose.
1. For self-testing: a lay person can use the device marked with this symbol even without professional medical experience;
2. Not for self-testing (to add on rapid tests’ labels only): the device must be used by a trained professional in an appropriate setting;
3. For near-patient testing: the device must be used by a trained professional in a near-patient setting;
4. Not for near-patient testing (to add on rapid tests’ labels only): the device must be used by a trained professional in a laboratory only.
Symbols are an effective tool because they are easy to identify, and their use avoids the necessity to meet language requirements. Anyway, since the mentioned symbols are not harmonised yet, they will need to be explained in the Instruction for Use.
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- Medical Device Coordination Group. (2020). Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. Retrieved on 30/12/2020 from https://ec.europa.eu/health/sites/
- Official Journal of the European Union. (2017). Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Retrieved on 30/12/2020 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN
- MedTech Europe. (2020). New IVD symbols for compliance with the IVDR. Retrieved on 30/12/2020 from https://www.medtecheurope.org/new-medical-technology-regulations/new-ivd-symbols-for-compliance-with-the-ivdr/