Equivalence Possibilities for Implantable and Class III Devices Under the EU MDR Considering the MDCG 2023-7 Guidance

Qserve CRO

 

By Patrícia da Silva Perez, Senior Consultant

The claim of equivalence allows manufacturers to use clinical data from an equivalent device (ED) during the clinical evaluation process of the device in question for the purpose of confirmation of conformity with the relevant general safety and performance requirements (GSPRs). Widely used under the Medical Devices Directive (MDD), this concept was strengthened with the advent of the Medical Devices Regulation (EU MDR) 2017/745. However, the MDCG 2023-7 guidance showed that its use is not as narrow as once thought! Please join me in navigating this guidance and understanding new possibilities that may be applicable to your implantable or class III device!

1. Equivalence under the EU MDR

Annex XIV Part A from the EU MDR states that clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated, considering technical, biological, and clinical characteristics. Those shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device and any considerations should be based on proper scientific justification. In addition, it shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify such claims.

From EU MDR article 61(4), we know that equivalence can be used for implantable and class III devices if the device under evaluation (DuE) is a modification from a previously marketed device by the same manufacturer, the equivalence is demonstrated in accordance with Annex XIV Part A [EU MDR], endorsed by the Notify Body and the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant GSPRs. In this case, an appropriate PMCF plan is required.

EU MDR Article 61(5) also applies for implantable and class III devices and presents the possibility of using EDs marketed by a different manufacturer. In order to do so, the two manufacturers must have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis. The ED’s clinical evaluation must be performed in compliance with the requirements of EU MDR and the manufacturer of the second device must provide clear evidence of that to the Notified Body.

Altogether, information from Article 61 and Annex XV part A [EU MDR] suggested that the use of an ED for implantable and class III medical devices was restricted to two situations:

  1. using an ED from the same manufacturer, in which the new device is a modification of a previous version that is already on the market; or
  2. using an ED from another manufacturer, in which there is a contract in place that allows full access of the technical documentation of the ED on an ongoing basis.

In both cases, the technical, biological, and clinical requirements for equivalence established in Annex XIV Part A [EU MDR] should still be fulfilled. However, the Medical Device Coordination Group (MDCG) released in December of 2023 the MDCG 2023-7- Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence, clarifying that the use of equivalence for implantable and class III devices is not as limited as we thought.

2. New possibilities clarified in MDCG 2023-7

MDCG 2023-7 is intended to clarify the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices to be placed on the European market. Here we will focus on the contribution of the guidance regarding the use of EDs. One of the most important inputs of this document is that it clarifies that the use of EDs from different manufacturers is not restricted to the existence of a contract between the two parties. On the contrary, it is extended to the situations presented in Article 61(6)(a) and Article 61(6)(b) from the EU MDR, meaning implantable or class III devices which:

  1. have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where such a CS is available [EU MDR Article 61(6)(a)];
  2. are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS, where such a CS is available.

The guidance explains that the requirement to have sufficient levels of access to the data required to establish equivalence does not require a contract in all circumstances; this is only required in the case described in EU MDR Article 61(5). In the other cases, different means of access to data can prove to be adequate to support demonstrations of equivalence. It even includes a specific subset case of Article 61(5), in which equivalence is fully demonstrated with more than one device from more than one manufacturer, and there is a contract in place with at least one of the manufacturers.

How do you ensure sufficient levels of access to technical documentation without a contract? MDCG 2023-7 goes deeper and offers examples of methods for accessing data needed to demonstrate equivalence between devices (Table 2, Appendix II), which may vary from publicly available information (low access level) to different manufacturers using the same production subcontractor (high access level). It suggests a hierarchy for accessing this data and highlights potential limitations of these methods, along with possible ways to address them. Such examples are quite helpful but are not exhaustive and therefore cannot be seen as a prescriptive guide. Keep in mind, a higher level of access to data does not correlate to a stronger demonstration of equivalence, and the equivalence conditions established in EU MDR Annex XIV Part A are still mandatory.

3. Concluding remarks

MDCG 2023-7 clarified that the use of clinical data of an ED for implantable and class III devices is not restricted to modified devices from the same manufacturer or having a contract in place with a different manufacturer. As long as the requisites of equivalence are fulfilled and the limitations for having lower level of access to the data of the ED are well addressed, a contract may not be mandatory, as presented in Figure 1. This gives manufacturers of implantable and class III devices more possibilities to put their device in the EU market while collecting device-specific data through PMCF activities.

Figure 1: Applicability of contract between manufacturers from the DuE and the ED.

It is important to highlight that such considerations regard implantable and class III devices. However, Section 4e from MDCG 2020-5 – Clinical Evaluation – Equivalence: A guide for manufacturers and notified bodies reinforces that “(…) for devices other than implantable devices and class III devices and where the manufacturer wants to claim equivalence (…) in the circumstance that the presumed equivalent device is from another manufacturer, there is no (EU) MDR requirement of a contract between the manufacturers for regulating the access to the technical documentation (…).” Therefore, we can infer that a contract is only mandatory for implantable and class III devices which fulfill EU MDR Article 61(5). For other cases, other means could be used for demonstrating sufficient levels of access to the data needed to justify claiming equivalence.

***Qserve can help you with equivalence demonstration for the clinical evaluation. Please contact us for a quote if you need any help.***

References

Regulation (EU) 2017/745 – EU MDR

MDCG 2020-5 – Clinical Evaluation – Equivalence: A guide for manufacturers and notified bodies

MDCG 2023-7- Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence

 

 

 

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