Compliance with the MDR Regulation at Wolturnus
At Wolturnus, we prioritize quality and safety in our medical devices. We ensure that all our products comply with the applicable requirements of Regulation (EU) 2017/745 on medical devices (MDR). This means that all Wolturnus products fully meet the conditions for placing Class I medical devices on the market, including the specific requirements of Articles 5, 20, and 52.
We have a valid EU Declaration of Conformity for all our products, as well as proper labeling and comprehensive instructions for use in accordance with Annex I of the MDR.
Wolturnus is registered in the European Database on Medical Devices (Eudamed) as a manufacturer of Class I medical devices.
Our quality management system is based on and developed according to ISO 13485, and we have implemented the necessary processes to comply with the latest medical device regulations.
This includes:
- Risk management and quality assurance throughout the entire production process
- Ongoing quality control with documented inspection forms
- Preparation of detailed instructions for use to ensure correct and safe application of our products
- A post-market surveillance system to ensure continuous evaluation of product quality and ongoing improvements based on collected data
In addition, several of our products have undergone crash testing to document their safety and reliability.
With Wolturnus, you can be confident that our products are developed, manufactured, and tested in accordance with the highest standards of quality and safety.
Below you can find the relevant EU Declarations of Conformity
You can download a ZIP-file containing all EU Declarations of Conformity for Wolturnus products here:
All EU Declarations of Conformity – Complete Download (ZIP)
Cushions
Covers
- Cushion Cover – EU Declaration of Conformity
- Cushion Cover Incontinence – EU Declaration of Conformity
Everyday Wheelchairs
- A-Run – EU Declaration of Conformity
- Dalton – EU Declaration of Conformity
- Gitano – EU Declaration of Conformity
- Hawk – EU Declaration of Conformity
- Merlin – EU Declaration of Conformity
- Tukan – EU Declaration of Conformity
- W5 – EU Declaration of Conformity
- W5 Crash Test – EU Declaration of Conformity
Sports Wheelchairs
- Basket – EU Declaration of Conformity
- Dancing – EU Declaration of Conformity
- Fencing – EU Declaration of Conformity
- Rugby – EU Declaration of Conformity
- Tennis – EU Declaration of Conformity
Handbikes
- Amasis – EU Declaration of Conformity
- Antaras – EU Declaration of Conformity
- Buzzard – EU Declaration of Conformity
- Fatbike – EU Declaration of Conformity
- Racebike – EU Declaration of Conformity
- Roadrunner – EU Declaration of Conformity
- Ski Sledge – EU Declaration of Conformity
- Zitkite Sledge – EU Declaration of Conformity
Electric Wheelchairs