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.

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.

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.

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.

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.

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.

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 1^st 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 26^th 2021), please get in touch with us at your earliest convenience.