MDCG 2020-5 Clinical Evaluation – Equivalence

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MDCG 2020-5, issued by the European Commission (EC), is a guide that explains how to show that a medical device is equivalent to another with a CE mark.

This guide is very important because proving equivalence in the EU is complex. Moreover, the EU MDR and MEDDEV 2.7/1 Rev. 4, a guide on clinical evaluation, use different terms for equivalence.

Let’s explore the contents of MDCG 2020-5 and understand why it’s crucial to comprehend this document when asserting equivalence in the EU.

What does MDCG 2020-5 focus on?

MDCG 2020-5 primarily focuses on explaining and resolving differences in the definitions of equivalence between MEDDEV 2.7/1 Rev. 4 and EU MDR. MEDDEV 2.7/1 Rev. 4, a guidance document from 2016, predates EU MDR, leading to disparities between the guidance and the regulations, causing confusion in demonstrating equivalence.

The document addresses these differences, outlines the prerequisites for determining equivalence in the EU, and provides guidance on identifying and using clinical data.

What are the three characteristics for demonstrating equivalence?

The three characteristics for demonstrating equivalence in the EU, as required by both MDR (Medical Device Regulation) and MEDDEV 2.7/1 Rev. 4, are:

  1. Technical Characteristics: This involves assessing the technical specifications and features of the medical device to determine if they are comparable to those of the reference device.
  2. Software equivalence: In the technical characteristics section, MDCG 2020-5 emphasizes that software equivalence is about the functional principle of an algorithm, clinical performance, and intended purpose. Importantly, it states that demanding equivalence for the actual software code is not reasonable.”
  3. Similar vs. Same Conditions: When it comes to technical characteristics, MDR mentions “similar conditions,” while MEDDEV 2.7/1 Rev. 4 states “same conditions of use.” MDCG 2020-5 clarifies that conditions should be similar enough to avoid clinically significant differences in safety and performance between the devices.”
  4. Biological Characteristics: Manufacturers must evaluate the biological aspects of the device, considering factors such as materials used, design features, and any potential impact on the biological environment.
  5. Biological characteristic exceptions: Exceptions to using “similar” materials for reviewing biological characteristics, as allowed by MEDDEV 2.7/1 Rev. 4, are explicitly deemed unacceptable under the MDR, according to MDCG 2020-5.
  6. Clinical Characteristics: This involves comparing the clinical performance and intended use of the device with the reference device. Manufacturers need to demonstrate that the clinical outcomes and usage align with the established standards.
  7. Same clinical condition or purpose: In the context of equivalence, MDR doesn’t explicitly state that devices must be used for the same medical indication, gender, and duration of use. However, MDCG 2020-5 emphasizes that MDR’s requirement focuses on using both devices for the same clinical condition or purpose, indirectly covering these aspects.

It’s important to note that while both MDR and MEDDEV 2.7/1 Rev. 4 emphasize these three characteristics, there are nuanced differences in the criteria for each characteristic, as outlined in the guidance document MDCG 2020-5.

Demonstrating equivalence according to MDCG 2020-5

After discussing the three characteristics, MDCG 2020-5 outlines the prerequisites necessary to demonstrate equivalence. Here are key points from Section 4 that you should pay attention to:

  • Manufacturers cannot combine parts from different devices to claim equivalence for their device. Combining elements from various devices to create an equivalent device is not allowed.
  • While you can use more than one equivalent device, each of these devices must be equivalent to the one under evaluation in all specified technical, biological, and clinical characteristics.
  • Throughout the equivalence demonstration process, you must identify and disclose any differences between your device and the one(s) you are claiming equivalency with.
  • For manufacturers of implantable and class III devices, an additional requirement exists. If claiming equivalency with a device from another company, there must be a contract in place allowing full access to that manufacturer’s technical documentation, as mandated by MDR.

Obtaining such a contract might be challenging for many manufacturers. If access to technical documentation is not possible, alternative approaches like clinical investigations may be necessary to establish the safety and clinical performance of your device instead of pursuing the equivalence route.

Use of clinical data according to MDCG 2020-5

Sections 5 and 6 of MDCG 2020-5 provide guidance on the use of data for demonstrating equivalence:

Section 5 of MDCG 2020-5 discusses data from similar devices, defined in MDR as a group of devices with similar intended purposes or common technology that allows classification in a generic manner without reflecting specific characteristics.

The guidance mentions situations where demonstrating equivalence with a similar device might be challenging, but the data from that device could still provide valuable insights.

  1. Ensure a comprehensive risk management system by identifying relevant hazards and clinical risks.
  2. Understand the current state of medical knowledge, the natural progression of diseases, and alternative treatment options.
  3. Define the scope of clinical evaluation by identifying design features in similar devices that may have special performance or safety concerns.
  4. Contribute insights for designing clinical investigations, post-market clinical follow-ups, and the post-market surveillance system.
  5. Identify relevant clinical outcome parameters for intended benefits, using published clinical data from similar devices.
  6. Establish minimum requirements for a quantified clinical benefit deemed clinically relevant or identify acceptable occurrence rates of risks and adverse events.

Section 6 emphasizes that all devices must undergo a clinical evaluation following MDR guidelines. In this assessment, it is crucial to identify all clinical data, including both positive and negative aspects. Importantly, this requirement pertains to both your device and the device you are trying to establish equivalence with.

When handling clinical data, it is essential to subject it to the data appraisal and data analysis steps within the clinical evaluation process. Detailed guidance on these steps can be located in Sections 8-10 of MEDDEV 2.7/1 Rev. 4.

Proving equivalence in the EU is a complex process demanding thorough documentation. If you have difficulties dealing with the clinical documentation, please contact us.