MDCG 2020-16 Guidance: Classification Rules for IVDs

The Medical Device Coordination Group (MDCG) has published an update to guidance document MDCG 2020-16 Rev.3 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.

What are the Changes Between Revision 2 and 3 in the MDCG 2020-16 Guidance?

In the definitions section, the definition of a kit, in relation to IVD’s, has been added. ‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof.

Rule 3(a):

• • ‘monkeypox virus’ has been added to the list of examples of Devices in Class C detecting sexually transmitted agents.

Rule 4(a):

• • Has been revised to clarify the difference in devices between Class B and D within this rule. Additional text has been added to describe devices intended for self-testing when part of the testing is performed by a lay-person and the description of what is not considered part of a self-testing procedure.
  • Devices intended by the manufacturer to be used for testing services offered to lay persons, including those offered by means of information society services, are considered devices for self-testing when the lay persons carry out at least a part of the testing procedure, such as adding a reagent or placing the specimen on a test cassette. Such actions do not include those needed to collect the specimen or to ensure specimen integrity and stability (see Rule 5).
  • Standalone specimen receptacles and kits intended for specimen collection, when intended to be used by lay persons for specimen collection only, including those offered to lay persons by means of information society services, are not considered devices for self-testing (see Rule 5).

Rule 5(c):

• • Has been heavily revised with the rationale of specimen receptacles (as defined in IVDR Article 2(3) classified as Class A. Rule 5(c) has been extensively revised to include kits included for specimen collection. Kits are classified according to the kits intended use but generally they are classified as Class A when they contain a specimen receptable. Specimen receptacles and kits may be components of a kit intended for testing. They may be CE marked and classified in their own right according to their intended purpose.
  • Rule 1.8 and 1.9 should be used for classifying the whole kit and the intended purpose of the kit will determine the classification. There are specimen receptacles or kits may be placed on the market separately from other IVD’s which are intended to be used together. In this case, Rule 1.2 must be referred to.

Additional clarification is also added for self-testing:

• • Specimen receptacles or kits intended for specimen collection intended for lay persons and placed on the market separately from the testing device are not considered devices for self-testing.
  • A specimen receptacle or a kit intended for specimen collection may be a component of a kit intended for testing in which the lay person not only collects the specimen but also performs one or more actions that are part of the testing procedure. In this case, the whole kit intended for testing is considered a device for self-testing (see Rule 4). As components of the kit intended for testing, the specimen receptacle or specimen collection kit may be CE-marked and classified in their own right according to their intended purpose and would not themselves be considered devices for self-testing.

Under Rule 5(c), examples have been added to aid in classification of the specimen receptacles and kits.

Examples (non-exhaustive):

• • ‘A standalone urine collection cup, a stool container, a saliva collection tube or a blood spot collection card (e.g. specimen collection via finger-prick) intended for subsequent in vitro diagnostic examination are in class A. – Standalone kits intended for the collection of saliva by the lay person for the purpose of detection of SARS-CoV-2 (by another device placed on the market separately) are in class A.
  • Standalone kits intended for the collection of stool by the lay person for the purpose of fecal occult blood detection in colorectal cancer screening by a professional laboratory (with another device placed on the market separately), including a paper sheet to collect stool, a plastic stick to collect samples and a pre-filled tube for conservation and transport are in class A.’

Rule 6:

• • Minor revision of example of a device intended for the detection of Influenza A/B virus – ‘non-pandemic’ was replaced with not ‘highly virulent’.

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