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.
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.
This refers to safety or performance information gathered from the device’s use, sourced from the following areas:
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.
This ensures that manufacturers keep up with current standards and address any emerging safety concerns.
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
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.
Yes, all pre-clinical data identified by the manufacturer must be included, along with post-market surveillance data.
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