Section C (part 2) — CEP, information materials, common specifications, equivalence, state of the art

Source: MDCG-2020-01.pdf pages 13-15 (document: MDCG 2020-13)

The application of CS, harmonised standards or other solutions is:

• Compliant with the applicable requirements of the MDR:

  Include any relevant comments

• Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below:

Add a clear description of any remaining minor non-compliance together with required follow-up actions to close them and timelines for their completion to be followed by the manufacturer.

The demonstration of equivalence

Is the clinical evaluation based upon clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated?

State Yes / No

Device(s) to which equivalence has been claimed: _____

Is the clinical evaluation based upon reports published in peer reviewed scientific literature on a device for which equivalence to the device in question can be demonstrated?

State Yes / No

If yes, specify the source(s) of the data, if it is the device in question, or an equivalent device, or both.

Device(s) to which equivalence has been claimed: _____

Device which is most relevant: _____

Assessment of equivalence

1. Equivalence rationales:

Indicate which devices are/are not equivalent, and confirm that data relating to devices which are not equivalent have been excluded from the analysis of clinical data for the purposes of demonstrating safety and performance.

If equivalence has been claimed to more than one device, each demonstration of equivalence can only be based on a single device. Each equivalent device must meet all three equivalence criteria (clinical, technical, biological).

2. Are the devices equivalent in accordance with Section 3 of Annex XIV including technical, biological and clinical characteristics?

State Yes / No

Identify any differences in these parameters, and verify why these are not expected to adversely affect the safety and performance of the medical device under evaluation.

Non-compliances identified and resolved for this section may be briefly described in this box

The demonstration of equivalence is:

• Compliant with the applicable requirements of the MDR:

  Include any relevant comments

• Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below:

Add a clear description of any remaining minor non-compliance together with required follow-up actions to close them and timelines for their completion to be followed by the manufacturer.

Access to data

Comment on the manufacturer's access to data, relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.

For implantable and Class III devices, if equivalence is claimed with a device marketed by another manufacturer, confirm that there is a current valid contract between the two manufacturers allowing ongoing access to the technical documentation in accordance with Article 61 (5) of the MDR.

Has the original clinical evaluation been performed in compliance with the requirements of Regulation 2017/745, and has the manufacturer of the second device provided clear evidence thereof?

State Yes / No

Confirm that access to data is sufficient to provide the manufacturer with enough information about the equivalent devices to support equivalence claims, including any testing which may have been undertaken to confirm equivalence of specifications/performance/etc.

Any other limitations with respect to equivalent devices:

Comment on any other limitations with respect to the equivalent devices or manufacturer's equivalence claims, and the extent to which these limitations impact the manufacturer's clinical evaluation and conclusions.

Non-compliances identified and resolved for this section may be briefly described in this box

Manufacturer demonstration of equivalence and access to data is:

• Compliant with the applicable requirements of the MDR:

  Include any relevant comments

• Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below:

Add a clear description of any remaining minor non-compliance together with required follow-up actions to close them and timelines for their completion to be followed by the manufacturer.

State of the art

Benchmark devices, state of the art and other available treatment options:

Describe the alternative available treatment options identified by the manufacturer which could offer comparable safety and performance for the same treatment indications / patient populations, etc.

Briefly describe how benchmarks for safety and performance have been identified by the manufacturer in terms of the state of the art. Benchmarks will normally be based on aggregate data from several devices considered to have acceptable performance (e.g. systematic reviews or registry analysis); if individual devices are selected as benchmarks for safety and performance, a suitable rationale should be provided.

Confirm that the manufacturer's description of the state of the art is based upon an appropriate literature search (see section D)?

For devices previously marketed, is the description of the state of the art still accurate? Can the device still be considered to be state of the art?

Safety, performance and benefit-risk claims - requirements in terms of the state of the art:

What performance and safety endpoints has the manufacturer identified?

In light of the outcomes achievable with benchmark products and other treatment options, are these endpoints appropriate and clinically relevant? Have surrogate endpoints been adequately justified?

Has the manufacturer adequately described an indicative list and specification of parameters used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device?

Non-compliances identified and resolved for this section may be briefly described in this box

Manufacturer demonstration of state of the art is:

• Compliant with the applicable requirements of the MDR:

  Include any relevant comments

• Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: