On 26 May 2021, the new EU Medical Devices Regulation (MDR) will come into force. Read up on all the latest information here or download all the notifications as a handy PDF on your computer, tablet or smartphone.
General and detailed information is also available from Eurocom, BIV-OT or DGIHV.
Dear Sir or Madam, in a few months, on 26 May 2021, the new EU Medical Devices Regulation 2017/745 (MDR) will come into force. Time and again, we receive queries about our products and about the new MDR. Of particular interest is the topic of the period of use of fitting parts for prostheses and orthoses. We would therefore like to assure you that nothing will change for you as a customer, because the introduction of the new MDR has no effect on the period of use of our products. Furthermore, the indication of the period of use has been a fixed part of our instructions for use for more than 10 years and will continue to be found there. In order to provide you with a detailed overview and answers to the most important questions on the subject of the period of use of fitting parts, you will find the MDR section on our website with immediate effect. There you can read all the information at any time and download it as a PDF if required. Click here to go directly to the FAQ's period of use of fitting parts. If you have any questions, please do not hesitate to contact us.
Your Streifeneder ortho.production GmbH
How is the period of use for fitting parts for orthoses and prostheses determined?
All Streifeneder ortho.production GmbH products pass through strict quality inspections and tests (e.g. DIN EN ISO 10328) - both before they come onto the market and throughout their availability on the market. This applies to various criteria: Design, manufacturing process, documentation and quality control. The data obtained from this form the basis for determining the period of use.
Where is the period of use recorded?
If a period of use is specified, it is always noted in the instructions for use under the keyword period of use.
Has the period of use been newly introduced due to the MDR?
No. The period of use has already been specified in the instructions for use of Streifeneder ortho.production GmbH for more than 10 years. The periods have not changed.
Does this mean that the use of a fitting parts is prohibited after the period of use has expired?
No. A manufacturer cannot make this restriction. The fitting parts are the property of the insurance provider or the patient. They alone ultimately decide on the actual period of use.
What is Streifeneder ortho.production's recommendation regarding the period of use?
As a manufacturer, Streifeneder ortho.production GmbH recommends taking into account the actual stress by the patient after the period of use has expired, in order to then replace the device if necessary. Regardless of the new MDR, the existing Medical Devices Act already stipulates that the safety and performance of medical devices must be guaranteed.
Conclusion
For customers of Streifeneder ortho.production GmbH, the new MDR does not change the period of use of fitting parts for orthoses and prostheses. The individual intensity of use continues to be decisive for the time of replacement. Customers can continue to rely on the performance and quality of all Streifeneder ortho.production GmbH products.