Spotlight

Is Our Device Eligible For Article 61(10)?

Clinical evaluation is defined in Article 2(44) of the EU Medical Device Regulation 2017/745 (MDR) as a ‘systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer’ and which should be performed for all devices complying with the EU MDR. The clinical evaluation is specifically the analysis of clinical data that is required to demonstrate conformity with General Safety and Performance Requirements (GSPR) 1 and 8 in Annex I.

However, there are instances in which the use of clinical data may not be appropriate to demonstrate conformity with these GSPRs, as allowed for by Article 61(10). Apart from implantable and Class III medical devices described in Article 61(4), manufacturers wishing to go for the Article 61(10) route are required to provide a detailed justification for this decision which shall be based on the following:

  • Risk management.
  • Specifics of the interaction between the device and the human body.
  • Clinical performance and claims made by the manufacturer.

This route requires manufacturers to demonstrate why it considers a demonstration of conformity with the GSPR that is based on results of non-clinical testing alone (performance evaluation, bench testing, pre-clinical evaluation) to be sufficient. To be clear, Article 61(10) is not a “get-out clause” which allows manufacturers to bypass requirements to put together a Clinical Evaluation Plan and Report, however, it allows for manufacturers of certain devices, typically low-risk, to avoid costly and time-consuming clinical investigations. Regardless of the device risk and intended purpose, all manufacturers must draw up the clinical evaluation documentation.

Manufacturers, going through Article 61(10) should use all the available data at hand, including:

  • Bench testing.
  • Simulated use.
  • Non-clinical testing (biocompatibility, usability, electrical safety).
  • Compliance with harmonised, non-harmonised, and other technical standards.
  • Post-market surveillance data.

This “allowance” seems to have evolved from Annex X (1.1d) of the EU Medical Device Directive 93/42/EEC (MDD), however, manufacturers who have previously applied 1.1d should still take note of the following, in case the device in question was incorrectly qualified.

The Million Dollar Question

Is our device eligible for Article 61(10)?

The application of Article 61(10) is not defined very well within the MDR, and perhaps it has been purposefully left vague. However, over the years of experience with Notified Body assessments, guidance, and conversations with stakeholders in the industry, we can agree that it depends on the following core principles:

  • Overall device risk and risk classification.
  • Device type.
  • Interaction between the device and human body.
  • Novelty.
  • Clinical performance and claims made by the manufacturer.
  • Suitability/appropriateness of a clinical investigation.

We’ll explain these points below.

Device Risk and Device Type

Risk management plays a major role in the applicability of Article 61(10) to a particular device. If the risk study indicates that there are relatively high residual risks, it may be more appropriate to collect further clinical data.

Article 61(10) automatically excludes implantable and Class III medical devices from this potential exclusion, but there are some exceptions, as highlighted in Article 61(4):

 In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:

  • the device has been designed by modifications of a device already marketed by the same manufacturer,
  • the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
  • the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.

In this case, the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.

In addition, clinical investigations need not be performed in the cases referred to in paragraph 6.

EU MDR, Article 61(4)

Therefore, the following devices mentioned in Article 61(6) may also be eligible for Article 61(10):

The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices and class III devices:

(a) which 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; or

(b) that 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.

EU MDR, Article 61(6)

Interaction with the Human Body

The manner in which the device is intended to interact with the human body will be a big contributor to the applicability of this route. Some considerations include:

  • Duration of contact with the body.
  • Type and novelty of contact and mode of action.
  • Area or tissue in contact.

If the device is interacting with the human body in a “new” way, that is, not as described in the current state of the art for that type of device, further clinical data may need to be obtained. As an example, although standard surgical instruments are surgically invasive, they will likely qualify for this route since their mode of interaction is well understood.

Novelty

In most cases, a novel device will likely be expected to conduct some level of clinical investigation since its mode of action and interaction with the human body would be largely unknown. However, this will depend on the nature of the interaction and what the actual intended purpose of the device is.

Clinical Performance and Claims

As a general rule of thumb, manufacturers of medical devices making claims of a clinical benefit to the patient shall substantiate these claims with adequate clinical data. For context, clinical performance is defined as:

the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer.

EU MDR, Article 2(52)

A Clinical Benefit is the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health, as defined in Article 2(53).

Furthermore, any clinical claims being made must be appropriately demonstrated by clinical data thus making Article 61(10) an unlikely route for such products.

Suitability/Appropriateness of a Clinical Investigation

In some cases, it may be inappropriate to collect data on a particular device, depending on the clinical claims being made. One such example would be a medical device that is intended to treat rare injuries such as those inflicted through warfare. It would be inappropriate for the manufacturer to inflict injury and treat patients. In such cases, it may be more appropriate to leverage the use of bench testing or other non-clinical testing.

Available Guidance

Section J of MDCG 2020-13 (Clinical evaluation assessment report template) provides the most detailed review of what Notified Bodies will be looking for when manufacturers apply Article 61(10):

  • A justification for reliance on Article 61(10).
  • Evidence that the manufacturer is relying on with respect to: Performance evaluation, Bench testing, Pre-clinical evaluation.

The guidance goes on to pose the following considerations to reviewers:

  • Has any available clinical data for the device or an equivalent device been searched for and/or identified by the manufacturer?
  • Is clinical data available for similar devices, does this provide information relevant to the safety and performance of the device under evaluation?
  • The results of the manufacturer’s risk management.
  • Consideration of the specifics of the interaction between the device and the human body.
  • The clinical performance intended.
  • The claims of the manufacturer.

In the event of products using Article 61(10), Post-Market Clinical Follow-up (PMCF) will need to be conducted in order to generate clinical data moving forward. A robust PMCF Plan must be in place in conjunction with a justification based on Article 61(10).

How we can help

We’ve assisted manufacturers struggling with their regulatory compliance specifically in relation to the applicability of Article 61(10) to their devices and submitted successful applications to Notified Bodies going down this route.

Specculo provides a wide array of regulatory services to help manufacturers comply with their requirements and obligations in both the EU and UK. Take a look at our services on our Regulatory Consulting page for more information, or get in touch with us today to learn more.