MDCG 2023-7: Clinical Investigation Exemptions & Claiming Equivalence
MDCG 2019-07 Updated: MDR/IVDR Art. 15, Person Responsible for Regulatory Compliance (PRRC)
January 3, 2024
EU Commission: New Dashboard Monitoring Availability of Medical Devices on the EU Market
January 9, 2024MDCG 2023-7 on clinical investigation exemptions and the level of data needed to justify claiming equivalence, was newly published in December 2023. It is available: HERE
Overview
The guidance is intended to 1) clarify the clinical investigation exemptions outlined under MDR Article 61, and 2) the conditions related to demonstrating equivalence to another device. It includes flowcharts and tables to help the reader make a determination.
The scope of this document only covers devices that are Class III and/or implantable. For other classifications and device types, the reader is directed to MDCG 2020-5 and MDCG 2020-6 for further guidance.
Below is a general overview of the guidance. Please refer to the full document for a comprehensive overview.
When is an implantable/Class III device exempt from clinical investigation?
| Situations/Cases | Criteria for exemption from the Article 61(4) requirement for clinical investigations for implantable and class III devices |
|---|---|
| CASE 1: Indents 1-3 of Article 61(4) | Device Under Evaluation has been designed by modification. Equivalence is demonstrated between the Device Under Evaluation and the manufacturer’s Equivalent Device in accordance with Section 3 of Annex XIV; demonstration of equivalence has been endorsed by the notified body. For further guidance on the demonstration of equivalence, please refer to MDCG 2020-5. The clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements. PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the Device Under Evaluation. |
| CASE 2: Article 61(6)(a) | Device Under Evaluation has been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC. The clinical evaluation is based on sufficient clinical data. The clinical evaluation is in compliance with the relevant product-specific Common Specification for the clinical evaluation of that kind of device, where such a Common Specification is available. |
| CASE 3: Article 61(6)(b) | Device Under Evaluation is one of the listed types of devices: “sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors”. The clinical evaluation is based on sufficient clinical data. The clinical evaluation is in compliance with the relevant product-specific Common Specification for the clinical evaluation of that kind of device, where such a Common Specification is available. |
| CASE 4: Article 61(5) | Equivalence is demonstrated between the Device Under Evaluation and the other manufacturer’s Equivalent Device in accordance with Section 3 of Annex XIV; demonstration of equivalence has been endorsed by the notified body (via Article 61(4)). The clinical data from the clinical evaluation of the Equivalent Device is sufficient to support the intended purposes of the Device Under Evaluation (via Article 61(4)). The two manufacturers have a contract in place that explicitly allows the manufacturer of the Equivalent Device full access to the technical documentation on an ongoing basis. The clinical evaluation of the other manufacturer’s Equivalent Device has been performed in compliance with the requirements of the MDR. PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the Device Under Evaluation (via Article 61(4)). |
The guidance document notes that each individual section (MDR Art. 61(4), 61(5), and 61(6)) are independent of one another. For example, Art. 61(5) is not conditional, based on 61(4) or 61(6).
If a clinical investigation is determined to be mandatory, the MDR does not specify the number or extent of the clinical investigation(s) required. However, as a minimum, mandatory clinical investigation(s) should be understood to mean a pivotal clinical investigation(s) generating pivotal data.
Demonstrating “sufficient levels of access to the data” to justify claims of equivalence
To ‘justify claims of equivalence’ is to have sufficient access to establish the clinical, technical, and biological characteristics against which equivalence is evaluated. This does not necessarily require access to the complete technical documentation.
Where there is no contract allowing the manufacturer to have full access to the Equivalent Device’s technical documentation on an ongoing basis, other means of access may prove adequate to demonstrate equivalence.
Below is the MDCG’s table of examples:
| Examples for demonstrating “sufficient access to data” | Level of access and potential limitations | Means of addressing limitations | |
| 1a. | Contract with the manufacturer of the Equivalent Device, allowing full access to the technical documentation on an ongoing basis | Level of access: Full. | n/a |
| 1b. | Device Under Evaluation is a design modification of a device already marketed by the same manufacturer | Level of access: Full. | n/a |
| 1c. | Rights to Device Under Evaluation acquired with transfer of all relevant design and clinical data at the time of acquisition | Level of access: Full. | n/a |
| 1d. | Device with the same design specification and intended purpose is supplied to several manufacturers by the same production subcontractor, and manufacturer has access to the technical specifications necessary to demonstrate technical and biological equivalence | Level of access: High. However, information on clinical safety and performance of the Equivalent Devices may be limited to data available in the public domain; this could introduce additional biases, such as publication bias, to the literature evaluation | Clinical data on the Device Under Evaluation (including data from pre- or post-market clinical sources) Literature data appraisal in accordance with relevant standards and guidance, to identify and evaluate potential sources of bias PMCF to supplement the available data and continually update the clinical evaluation as per Annex XIV Part B |
| 2 | Comparative analysis and/or testing of devices based on samples of both devices (Device Under Evaluation and Equivalent Device), coupled with information available in the public domain (e.g. IFU, surgical technique brochures, SSCP, etc.) | Level of access: Medium. Information regarding device history and design changes may be limited, particularly in cases where the state of the art for the category of devices has had significant evolution over its history. There may be inaccurate correlation of design variants to studies published in literature, due to above limitations of information regarding device history and design changes. Information on clinical safety and performance of the other manufacturer’s Equivalent Devices may be limited to data available in the public domain; this could introduce additional biases, such as publication bias, to the literature evaluation. | Evaluation of the design history of the Equivalent Device and potential impact of knowledge gaps with respect to ability to correlate a specific design variant with studies published in the literature Clinical data on the Device Under Evaluation (including data from pre- or post- market clinical investigations) Literature data appraisal in accordance with relevant standards and guidance, to identify potential sources of bias PMCF to supplement the available data and continually update the clinical evaluation as per Annex XIV Part B |
| 3a. | Device with the same design specification and intended purpose is supplied to several manufacturers by the same production subcontractor, but access to data needed to establish equivalence only available through publicly available information | Level of access: Medium to low, depending on the availability and quality of publicly available information; this could introduce additional biases, such as publication bias, to the literature evaluation. | Clinical data on the Device Under Evaluation (including data from pre- or post-market clinical sources) Literature data appraisal in accordance with relevant standards and guidance, to identify and evaluate potential sources of bias PMCF to supplement the available data and continually update the clinical evaluation as per Annex XIV Part B |
| 3b. | Product specification determined solely through publicly available information | Level of access: Low, depending on the availability and quality of publicly available information. There may be additional limitations with respect to accuracies in publicly available information / inability to verify publicly available information | Evaluation of the design history of the Equivalent Device and potential impact of knowledge gaps with respect to ability to correlate a specific design variant with studies published in the literature Clinical data on the Device Under Evaluation (including data from pre- or post-market clinical investigations) Literature data appraisal in accordance with relevant standards and guidance, to identify potential sources of bias PMCF to supplement the available data and continually update the clinical evaluation as per Annex XIV Part B |
If a manufacturer cannot demonstrate sufficient levels of access to the data needed to demonstration equivalence, then equivalence claims cannot be made for the purpose of conformity assessment. Further, having full access to the technical documentation is not synonymous with equivalency. Even with full access, the devices could still have differences in clinical, technical, or biological equivalence criteria.
The manufacturer of the Device Under Evaluation must document their justification within the CER as to why the level of access they have obtained is sufficient, and this has to be accepted by the Notified Body.
