Medical devices in Europe must comply with the EU’s legal requirements. These requirements are described in the Medical Device Regulation (MDR). The purpose of the MDR is to ensure the safety and quality of medical devices.
Regarding the medical devices (such as orthotic insoles) supplied by Podotherapie Arjan Smeele, the following applies:
- They are medical devices of class I.
- The medical devices are individually customized and can therefore only be used by the person for whom they are intended.
- Delivery of the medical devices is in accordance with the applicable MDR guidelines (EU Regulation 2017/745, Annex II and XIII).
- The medical devices comply with the essential safety and performance requirements in accordance with the applicable guidelines.
- During the process of manufacturing and delivering, the medical devices are checked at various stages and components.
This text has been revised on 04-04-2023