New Updates to IVD Classification Guidance Document MDCG 2020-16 r3 - Clarify Guidance for Self-Testing and Specimen Receptacle Devices

Section

Update

Definitions

A definition for ‘kit’ was 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) examples

The examples were revised to now include Monkeypox virus as part of devices intended to detect the presence of, or exposure to, a sexually transmitted agent.

Rule 4(a) Self-test rationale

The rationale for Rule 4(a) for self-testing IVDs was expanded to provide more detailed guidance, including:

• Clarification for which devices can be considered class B in this rule.
• Corrections to implementing rule references to include rules 1.8 and 1.9 when devices detect more than one marker.
• Clarification that devices intended by the manufacturer to be used for testing services offered to lay persons, including those offered by means of ‘information society services’ (i.e., via the internet), are considered devices for self-testing when the lay persons carry out any part of the testing procedure.
  • Examples include when the lay person must add a reagent or place the specimen on a test cassette.
  • This is not to be confused with actions needed to simply collect the specimen or to ensure specimen integrity and stability as these actions used for specimen receptacles and specimen collection kits may qualify as class A per Rule 5.
• Clarification that 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.

Rule 4(a) Self-test examples

The self-testing device examples were revised to:

• Clarify that meters and strips containing integrated testing reagent for self-testing of capillary blood glucose are in class C (not class B as Rule 4’s rationale might otherwise infer).
• Add that devices intended to measure levels of calprotectin where the lay person collects the stool specimen, carries out the testing procedure using the test cassette and sends an image of the result to be interpreted by a healthcare professional are in class C.
• Add that self-testing kits for detection of HIV antibodies from a fingerstick blood sample are in class D (as per Rule 1 and implementing rule 1.9).

Rule 5(c) specimen receptacle rationale

Rationale for Rule 5(c) specimen receptacles was added where there was previously no rationale. This new rationale:

• Expands on the IVDR’s Article 2(3) definition of a specimen receptacle.
• Clarifies that these devices cannot have any integrated testing functions as these must only function for the primary containment and/or preservation of specimens.
• Clarifies how specimen receptacles may be placed on the market as standalone devices or as part of kits containing various other types of products (whether or not covered by the MDR or IVDR).
• Clarifies that specimens collected and placed into specimen receptacles can require limited lay person actions and still qualify as class A specimen receptacles, but these actions must still fit the specimen receptable definition for only helping to contain and preserve the specimen. These actions cannot be part of the testing procedure (see updated Rule 4(a) rationale).
• Clarifies and reminds manufacturers that kits intended for specimen collection must still be classified according to the kit’s intended purpose and are still subject to implementing rule 1.9, where the kit takes on the highest classification when several classification rules apply to the kit.
• Clarifies that when specimen receptacles and kits intended for specimen collection (SR/KISC) are components of a kit intended for testing, even though these may be CE-marked and classified in their own right according to their intended purpose, the whole kit intended for testing is classified according to implementing rules 1.8 and 1.9 and takes on the highest classification when several rules apply to the testing kit. In these cases, the intended purpose of the testing kit will determine the classification for the included SR/KISC, which means these may be classified higher than class A.
• Clarifies that when SR/KISC are placed on the market separately but intended by the manufacturer to be used in combination with another IVD, implementing rule 1.2 applies. This means that the SR/KISC remain independently classified based on their intended purpose under the IVDR and are not subject to implementing rules 1.8 or 1.9.
• Provides detailed explanations for SR/KISC intended for use by lay persons to help interpret Rule 5(c), including:
  • SR/KISC intended for lay persons that are placed on the market separately from the test device are not considered devices for self-testing.
  • A SR/KISC 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). However, as components of the kit intended for testing, the SR/KISC may be independently CE-marked and classified in their own right according to their intended purpose and would not themselves be considered devices for self-testing.
• Reminds manufacturers that according to Article 1(3)(b), sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen are themselves not IVDs.

Rule 5(c) specimen receptacle examples

The example in the previous version of the guidance (rev 2) was simply an expanded definition of specimen receptacle. Example cases for SR/KISC are now provided.

Rule 6

A minor revision was made to the last device example intended for detection of influenza A/B to change “non-pandemic” to “not highly virulent”.