HR FEET is taking a new step forward in the quality and compliance of its products:
from now on, every custom-made orthopedic insole will be accompanied by a declaration of conformity.
This measure is part of the approach to holding custom-made medical device manufacturers accountable and strengthens our quality commitment to your patients and to our collaboration.
What is a declaration of conformity?
The declaration of conformity is a regulatory document certifying that each medical device manufactured meets the essential safety and performance requirements defined by European regulations (Regulation (EU) 2017/745).
It guarantees full traceability of the manufacturing process, from prescription to delivery, and certifies that the materials, processes, and quality controls meet the required standards.
In other words, it is the “regulatory identity card” of your insole: official proof that the device provided to your patient is safe, compliant, and manufactured in accordance with best practice.
Why this approach?
To strengthen transparency between the practitioner, the patient, and the manufacturer.
To secure podiatric practice by ensuring that each device complies with European standards.
To enhance your work as a prescriber by guaranteeing exemplary traceability.
To anticipate upcoming regulatory requirements and maintain the high level of quality that HR FEET is known for.
In practice
Each order of custom-made insoles will now be delivered with its specific declaration of conformity, linked to the manufacturing batch number.
This document can be downloaded from “order management” and must be kept in the patient file, in accordance with the legal traceability requirements.
This approach confirms HR FEET’s commitment to supporting its partner podiatrists with a demanding, responsible, and sustainable approach to manufacturing custom-made medical devices.
