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ARTICLE 61(10) OF REGULATION (EU) 2017/745

Introduction

Article 61(10) specifies that a medical device must meet certain conditions to be included in clinical evaluation requirements.

If a device is modified but already marketed by the same manufacturer, it must be shown to be equivalent to the existing device. This demonstration must follow Section 3 of Annex 14 and receive approval from a notified body. Additionally, the clinical evaluation must confirm the modified device’s safety and effectiveness.

The way a device interacts with the human body is critical in determining if further clinical data is needed. Even though standard surgical instruments are invasive, their well-known interaction with the body often qualifies them under this regulation.

Innovative or novel devices, without any predicate device, typically require clinical investigation, as their intended interaction with the human body is less understood. Whether clinical data is necessary depends on the nature of the interaction and the device’s intended use, as claimed by the manufacturer.

According to Article 2(52) of the EU MDR, a device’s ability to deliver its intended medical effect through its technical or diagnostic features is key. This is what ultimately leads to the clinical benefit intended by the manufacturer.

Exceptions

When a medical device manufacturer claims that their device offers a clinical benefit, clinical data must be gathered and evaluated by the manufacturer. In such cases, Article 61 (10) no longer applies. It’s important to also assess any other claims made by the manufacturer and ensure that appropriate evidence supports them. Along with these claims, the device’s risk factors and its interaction with the human body must always be carefully considered.

Clinical Data

This refers to safety or performance information gathered from the device’s use, sourced from the following areas:

  • Clinical Investigation of the Device: Data from direct studies on the device in question.
  • Scientific Literature & Clinical Investigations: Studies or reports from scientific literature where the device’s equivalence to another can be demonstrated.
  • Peer-Reviewed Journals: Reports on other clinical experiences with a device that is proven equivalent to the one in question.
  • Post-Market Surveillance: Clinically relevant data from ongoing post-market monitoring, especially post-market clinical follow-up.

Devices qualifying under Article 61(10) generally do not make clinical claims. This provision is not a pathway for devices lacking clinical data, but rather for those with insufficient data.

ARTICLE-61

Here are examples of data types that can support Article 61(10) devices

  • Compliance with Non-Clinical Common Specifications: Devices must meet non-clinical requirements outlined in common specifications that are crucial for safety and performance. This can include mechanical testing to ensure strength and endurance, biological safety, and usability. Such specifications may address clinically relevant endpoints through non-clinical evidence.
  • Simulated Use, Animal, or Cadaveric Testing: Testing involving healthcare professionals or end-users is another form of non-clinical data that helps confirm conformity to relevant GSPRs. While not considered clinical data, this method is especially valuable for assessing the usability of accessories or instruments.
  • Pre-Clinical and Bench Testing Compliance: Pre-clinical and bench tests serve to demonstrate safety and performance by addressing clinically relevant aspects through non-clinical means. These tests often involve mechanical strength, endurance testing, biological safety assessments, and usability evaluations.
  • PMS/Vigilance Data: If the device has already been marketed, Post-Market Surveillance (PMS) and vigilance data provide insights into real-world performance and safety.

According to Article 61(10), manufacturers are still required to compile the clinical data or evaluations in a Clinical Evaluation Report (CER). This report must also include:

  • Literature searches to determine if the device remains state of the art, while exploring any new treatment options.
  • An evaluation of whether the search terms and criteria used are still valid and relevant to identify any previously unknown data.

This ensures that manufacturers keep up with current standards and address any emerging safety concerns.

How Maven Can Help

At Maven, we’ve supported countless medical device manufacturers in navigating complex regulatory challenges, particularly in meeting the requirements of Article 61 (10). Our expertise has led to the successful submission of applications to Notified Bodies. We provide comprehensive regulatory consultation services, ensuring manufacturers meet globally recognized compliance standards with ease.



Author – Mahesh Iyer

Frequently Asked Questions

  • Yes, under the MDR, these devices are not exempt from submitting a clinical evaluation report (CER), nor are they excluded from Notified Body assessments. The MDCG 2020-13 CEAR template includes a specific section for Notified Bodies to complete for Article 61 (10).

  • Yes, if harmonized standards or common specifications have been identified, they must be listed, and any discrepancies should be clearly noted.

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