February 16, 2021 - RQM+ experts summarize the MDCG guidance from November 2020, Guidance on Classification Rules for the in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, to aid IVD industry stakeholders in understanding, planning, and executing compliance to the IVDR by May 2022. The examples in the blogpost are not intended to be exhaustive of all scenarios of applicability.
By: Ashley Clark, MSc. RAC, RQM+ Senior Specialist
The Medical Device Coordination Group (MDCG) was established to support the Commission and Member States in ensuring harmonized implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) . The recent guidance document, MDCG 2020-16, published by the Group provides timely support to In vitro Diagnostic (IVD) industry stakeholders as they prepare for the transition to the new regulation on May 26, 2022.
Direction from the MDCG is especially critical for the transition to IVDR. Under the IVD Directive, the majority of IVD manufacturers could self-certify but under the new IVD Regulation, that same majority now requires a notified body for placing devices into service in the European Union (EU) .
What helpful information is in MDCG 2020-16?
The guidance provides:
- Explanation of multiple key terms, including the intended purpose
- Clarification on how to apply classification rules in IVDR, Annex VIII
How does this help?
Intended purpose clarification
The intended purpose drives risk-based classification decisions. The downstream impact of the initial classification decision will impact the conformity assessment route, which may include EU reference laboratories or consultation with applicable national or European Medicines Agency (EMA) .
IVDR communicates that the intended purpose is what is stated on labeling, instructions for use (IFU), promotional or sales material, or statements specified by the manufacturer performance evaluation .
The guidance goes beyond this concise statement to demonstrate how the intended purpose ties to the classification through examples of each rule and how they should be applied.
- A device intended to screen blood and tissue donations for syphilis would fall under class D according to rule 1.
- Alternatively, a device intended to diagnose syphilis, a sexually transmitted agent, in the individual would fall under Class C according to Rule 3a.
The key difference here being the intended purpose to screen for syphilis in tissues for donation versus the intended purpose to screen for syphilis in an individual.
Application to technologies, specimen, and software
Unless specified, the rules apply equally to all technologies, specimen, or software that are applicable . It worth noting that for software classification, software that works independently of the device is classified in its own right. Conversely, software that influences the function of the device is classified the same as the device .
- A smartwatch app, which is intended to send alarm notifications to the user and/or health practitioner when it recognizes irregular heartbeats for the purpose of detecting cardiac arrhythmia, would be classified as a medical device .
- Software intended to measure and transmit blood glucose levels, calculate the insulin dose required, and drive the insulin pump to administer the calculated dosage (closed-loop insulin delivery system)  would be classified with the insulin pump.
Classification of devices used in combination versus accessories
Some devices used in combination with another device are classified independently while others are classified with their combinatory device. The guidance points to implementing rules in Annex VIII of IVDR to support the classification of combination devices . The implementation rules call out specific exceptions to the general rule of devices whose intended purpose is to be used with another device will be classified on its own.
Exceptions include specific software, calibrators, and control materials [3,4]. These devices are classified with the device with which they are intended to be used. Conversely, other devices or reagents intended to be used with an IVD will be classified in their own right.
- A calibration solution intended to be used with an assay to detect HIV in an individual will have the same classification as the assay.
- A positive control intended to be used with an assay to detect CMV in an individual will have the same classification as the assay.
- A cytological slide that is intended to collect and preserve and/or transport a cytology specimen that can be used in a cytological slide processor would have its own classification.
To illustrate the beneficial nature of the guidance, a sampling of examples provided in the guidance are shared below.
Clarification on classification rules
Rule 1, indent 1
Devices intended to be used for the detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues, or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation, or cell administration are class D.
- A device intended to detect donor plasma for the presence of transmissible agents like Anti-HCV (Hepatitis C Virus) antibodies for exposure to Hepatitis C will be Class D.
Devices intended to be used for blood grouping or to determine fetal-maternal blood group incompatibility, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue, or organs that are intended for transfusion or transplantation or cell administration, are classified as class C except when intended to determine: ABO blood typing, Rhesus, Kell, Kidd or Duffy system markers in which case they are class D .
- A medical device software for analysis of HLA (Human Leukocyte Antigen) sequencing data for transplantation purposes is class C because it does not detect ABO blood type, Rhesus, Kell, Kidd, or Duffy system markers.
- A red blood cell kit with A1, A2, B, and O cells intended to detect naturally occurring ABO blood group antibodies in patient and donor samples is class C because it detects ABO blood types as described in Rule 2.
Devices intended for detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death, or severe disability to the individual, fetus, or embryo being tested or the individual’s offspring are class C .
- IVD intended to detect type B meningitis, Legionella ssp., or Zika virus would be class C because an erroneous negative result could result in:
- Death or harm to an individual, (i.e. meningitis or Legionnaires’ disease) or
- Death or harm to a fetus, embryo, or an individual’s offspring (Zika Virus).
Devices intended for self-testing are classified as class C, except for devices for the detection of pregnancy, fertility testing, cholesterol level, and devices for detection of glucose, RBC, WBCs, and bacteria in urine which are class B.
- A urine dip-strip intended to detect glucose in urine for home testing, class B because it is testing urine for glucose.
- A glucose meter for self-testing blood is class C because it is testing for glucose in the blood, not in urine.
Products for general laboratory use, with no critical characteristics intended by the manufacturer to make them suitable for a specific IVD relating to a specific examination, are class A.
- Solutions like cleaners, buffers, lysing solutions, and diluents specified for use with an IVD.
Catch all classification for any devices not mentioned in rules 1-5, and those devices are class B.
This risk classification is justified by the fact that an erroneous result is unlikely to have a negative impact on patient outcome, cause death, severe disability, or put an individual in immediate danger.
- A device intended for the detection of Candida albicans or “thrush” on the skin, is class B because it is unlikely to have an immediate negative impact on the individual’s outcome if the test was erroneously positive or negative.
- A device intended to detect Follicle Stimulating Hormone (FSH) in the blood is class B. This is for the same rationale as the device above, an erroneous result is unlikely to have an immediate negative impact on the individual.
Devices with are controls without a negative or qualitative assigned value are class B.
Examples for this rule are less intuitive than some of the others above. Discussion from the guidance notes that internally certified reference materials or materials used for external quality assessment schemes are not IVDs at all .
- Control materials used to verify migration of immunochromatographic assays are class B because there is no value or associated result with it. These are the lines that show that the assay itself is functional but does not tell you the result.
This guidance offers great support for the preparation of technical documentation for notified body submission and review, however, Member States may have additional requirements to enter a specific market. The MDCG 2020-16 guidance provides timely clarification for classification decisions given the fast-approaching IVDR implementation date and increased notified body scrutiny going forward. This guidance provides examples of devices for each rule and the association of classification with their intended purpose.
1. European Commission website. Register of Commission Expert Groups and Other Similar Entities. Medical Device Coordination Group (X03565).Published 10 January 2018. Accessed 13 January 2021. https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=3565
2. BSI website. In Vitro Diagnostic Regulation (IVDR). Why is this change so significant for IVD manufacturers? Accessed 27 January 2021. https://www.bsigroup.com/en-US/medical-devices/Our-services/IVDR-Revision/.
3. Medical Device Coordination Group Document. MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. Published November 2020. Accessed 27 January 2021. https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-md_en.pdf
4. 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. Accessed 27 January 2021. https://eur-lex.europa.eu/eli/reg/2017/746/oj
5. Medical Device Coordination Group Document. MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. Published October 2019. Accessed 27 January 2021. https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_mdcg_2019_11_guidance_en.pdf
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