The European Medical Device Regulation comes into effect on May 26, 2021. Here’s how we prepared for it.
Please read carefully the following 9 main points concerning our final preparations for the MDR era
Medical devices vs mere components
Medical product families
CE-marking and declarations of conformity
Instructions for use
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.
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.
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.
Certified for your benefit
We are proud to announce that we are the first company in our field to be compliant with the ISO 13485 standard!
We are facing a difficult situation due to the global pandemic. So many things that we have taken for granted are now at risk and we certainly don’t want to add the risk of not meeting regulatory demands.
At the same time we constantly want to improve the quality of our products and services to ensure we not only meet but exceed our customers’ expectations.
This means our products fulfill not only the higher standards of quality but also the regulatory requirements for medical devices.
Find out more about how regulatory compliance affects Rehadapt’s portfolio and represents your advantage by ensuring safety and a superior quality level throughout the entire life cycle of your personal mounting solution.
Rehadapt & regulatory compliance
The medical device regulation (MDR) of the European Union and the upcoming requirements of the FDA (the US regulatory body) elevates Rehadapt products to a new
level of quality and reliability. Find out more about how regulatory compliance affects Rehadapt’s portfolio and represents your advantage.
Significant changes ahead!
How regulatory compliance affects Rehadapt’s portfolio and represents your advantage
The new Medical Device Regulation (MDR) will be enforced in the European Union from the coming spring onwards. To ensure compliance with the MDR, we will apply changes to our portfolio across the board. The changes will also meet upcoming requirements of the FDA (the US regulatory body) and will feature many improvements requested by our partners. We will apply the new structures globally, so the changes will be consistent across Europe, the United States and elsewhere.
To put it briefly:
All our wheelchair mounting bundles will get updated and receive new product codes.
The ordering process for wheelchair mounts will change.
These changes will affect the price structure of our products.
The changes will take effect from January 1, 2021
Rehadapt wheelchair mount bundles will no longer include any frame clamp by default
Any product following the requirements for a Medical Device must have consistency and be labelled with a Unique Device Identifier (UDI). To achieve this without compromising the needed flexibility to meet individual client demands, we separated wheelchair mount bundles from frame clamps. Please do not forget to order your frame clamp in addition to the wheelchair mount.
All Rehadapt wheelchair frame clamps will have the same price
Frame clamps are treated as independent products following the guidelines for Medical Devices. To make life easier for our customers, we will apply equal pricing to all frame clamps. This flat rate is an exact average of all previous frame clamp pricing.
Most wheelchair mounts will include lever/bolt variations, and some excess tubes
For the sake of standardization and simplification, some bundles will include more parts than actually needed. We may include (for some bundles) a choice of tubes of varying length and both lever and bolt variations. Similarly, when delivering QuickShift levers for toolless operation, we may also deliver the corresponding Allen screws – in case setups need to be secured. We are confident the additional tubes and parts will provide more flexibility on the customer end when assembling the mount.
The effort in delivering the excess material is lower than the expenditure of handling individualized items, and we are confident our customers will enjoy the increased flexibility.
Wheelchair mounts will be delivered pre-assembled in standardized packaging
To further simplify the application of our products, we will deliver wheelchair mounts largely pre-assembled. We will switch to using standardized single packages per mount, using hassle-free and eco-friendly materials. The boxes allow for neat storage as well as easy forwarding to end users/customers, as they can be used as shipping containers. Matching outer packaging of boxes allow for safe and efficient delivery of multiples mounts.
Changes take effect January 1, 2021, and legacy commitments will be honored through May 21st 2021
We are aware that any change in our portfolio and processes means a burden to our partners. Quotations, databases, pricelists and staff routines will undoubtedly be affected. However, we are convinced you will benefit immensely from our new levels of standardization and simplification, while continuing to enjoy the flexibility you have always loved about Rehadapt products.
The attached pricelist is binding from the 1st of January for all new business. However, we do have options to fulfil legacy quotations until the end of May. In case tenders or other commitments require arrangements beyond the enforcement date of MDR (May 26th 2021), please get in touch with us at your earliest convenience.
List of all new products which will replace other products of our current portfolio in 2021
40 Oser Ave, Suite 40-01
Hauppauge, NY 11788
Tel +1 888 635 6962
Fax +1 888 635 6962
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