As you know, functionality and quality have been two core values of Rehadapt products. As the MDR will soon be enforced most products in our portfolio – while not deemed medical devices themselves – are accessories for medical devices and shall comply with the same regulations and abide by the same standards are medical devices. Assuring regulatory compliance was the reason behind restructuring our wheelchair mounts, our emphasis on training and step-by-steps videos, and our recent EN ISO 13485:2016 certification.
Medical devices vs mere components
All Rehadapt products deemed medical devices comply with the regulatory demands of Class I and nothing changes in the way they are purchased and handled. However a lot of effort has been put into our internal files (technical documentation, risk analysis, clinical records, post-market surveillance, etc.). These medical devices are complete mounting solutions with a well-defined intended purpose. This is where they differ from single components.
Our products are well-known for their modularity, and you can use these components not only for replacing parts in existing mounts but also for building mounts from scratch.
Modifying a medical device is strongly discouraged by the MDR. Yet while replacing a component (e.g. swapping a tube for a shorter one) is in fact a modification, it does not affect the intended purpose and can be done when there is no other option. Furthermore, our tests and risk assessments have shown that slightly modified tube lengths, as long as in the standard scope of our offered components, do not jeopardize safety and efficiency of the entire product.
However, when building a mount from a set of loose components, you are “creating a medical product” and become the manufacturer (with all the responsibilities that it entails).
Now let’s talk about specific details and regulatory requirements our products now meet.
Medical product families
Rehadapt products deemed medical devices can be grouped into 6 so-called product families. Each of which with its own Basic UDI-DI.
All individual products included in these product groups have their own UDI-DI, as listed on the table attached.
CE-marking and declarations of conformity
Rehadapt medical devices manufactured from May 26, 2021 will bear the CE-Marking. This means the declarations of conformity for these product families are available upon request.
Rehadapt medical devices can be easily identified as such by the MD symbol on the label. These new labels are compliant with the labelling requirements from the FDA and MDR.
Among other things they include the CE Marking of Conformity and the UDI in both human- and machine-readable manner.
See the representative example of Rehadapt labels for the Floorstand Mini on the right.
Instructions for use
The instructions for use for Rehadapt’s medical devices consist of 2 parts:
- Assembly and handling instructions, which is merely graphical and is therefore independent from any language. Important information in this booklet or leaflet includes the scope of delivery and technical reference (when appropriate).
- General safety instructions and warnings, which are translated into the official languages of all Member States where our devices are currently sold. This includes important information such as the intended purpose, glossary of symbols, maintenance and servicing guidelines, general cleaning and disinfection guidelines, warranty policy, etc.
Please make sure to read these documents carefully and forward them to end users and professionals who handle the products.
You will find the instructions for use of the floorstand mini (14.1100) attached. This is a representative example for the scheme we use with all instructions. All our assembly and handling instructions will be gradually changed to match this template.
We are introducing a new remote training concept. It consists of a personalized course with our sales team and a kit with all the parts needed for a hands-on experience. Practicing your mounting skills has never been as easy and can be done from home.
Contact our sales team if would like to know more.
It is important that the persons laying out a mounting solution for a customer are well trained. Installing the mount initially also requires some basic knowledge. We have frequently been asked whether the installation procedure necessarily has to be done by a trained advisor or a service technician.
The planning advisors know the environment parameters and should be able to judge the competencies of the caregivers or healthcare professionals involved. They may come to the conclusion that with proper instructions an installment can be done remotely, without the advisor or technician being on site.
Rehadapt does not generally oppose this, we just want to point out that it is your responsibility to make sure the involved persons are properly instructed.
You will notice on the general safety instructions that we recommend regular servicing every two years. Maintenance sheets will be made available for download on our website. Stay tuned to our newsletter for more information about this.
Finally and to keep in line with this string of documentation, we have drafted a distributorship agreement that you can also find attached. We invite you to read it carefully and we will approach you personally in the next coming weeks in order to bilaterally sign it. This is necessary to document that we mutually fulfil all regulatory demands, it serves both your organization as well as ourselves.
Please address any questions around the agreement to our sales team.