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

Core changes

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

Wheelchair Mounts / Monty 3D

2020 2021
11.1016 Monty 3Dreplaced11.3100 Monty 3D
11.2016 Monty 3D S
11.2516 Monty 3D QuickShift
replaced11.3211 Monty 3D QuickShift
11.3016 Monty 3D K Rdiscontinued 
11.3116 Monty 3D K Ldiscontinued 
 new11.3311 Monty 3D QuickShift Sturdy
11.2616 Monty 3D EyeControlreplaced11.3312 Monty 3D Plus
11.2916 Monty 3D EyeControl HDreplaced11.4312 Monty 3D Plus HD
11.4000 Monty 2R S
11.4500 Monty 2R QS
replaced11.2211 Monty 3D TT
11.4600 Monty 2R DCreplaced11.2312 Monty 3D TT Plus
11.4700 Monty 3D Curved M
11.4701 Monty 3D Curved M QS
replaced11.5311 Monty 3D Curved M
11.4710 Monty 3D Curved L
11.4711 Monty 3D Curved L QS
replaced11.6312 Monty 3D Curved L
11.4720 Monty 3D Curved XL
11.4721 Monty 3D Curved XL QS
replaced11.7312 Monty 3D Curved XL

Wheelchair Mounts / Hybrid 3D

20202021
13.3053 H3D W/C 3QSreplaced13.4215 Hybrid 3D Long UDS
13.3153 H3D W/C 3QS-Ureplaced13.4211 Hybrid 3D Long SLS
13.2153 H3D W/C 3QS-U Specialreplaced13.3211 Hybrid 3D Short SLS
new13.4211 Hybrid 3D Long SLS

Wheelchair Mounts / Light 3D

20202021
14.3001 L3D WC 1AK
14.3051 L3D WC 1QS
discontinued
14.3002 L3D WC 2AK
14.3052 L3D WC 2QS
replaced14.2015 Light 3D TT SLS
14.3003 L3D WC 3AK
14.3053 L3D WC 3QS
replaced14.3215 Light 3D QuickShift SLS
14.3101 L3D WC 1AK-U
14.3151 L3D WC 1QS-U
discontinued
14.3102 L3D WC 2AK-U
14.3152 L3D WC 2QS-U
replaced14.2211 Light 3D TT UDS
14.3103 L3D WC 3AK-U
14.3153 L3D WC 3QS-U
replaced14.3211 Light 3D QuickShift UDS
14.1000 L3D WC 2AK 1 Switch
14.1050 L3D WC 2QS 1 Switch
replaced14.2415 Light 3D Headrest 1 Switch
new14.2515 Light 3D Headrest 1 Switch Flex
14.2000 L3D WC 2AK 2 Switch
14.2050 L3D WC 2QS 2 Switch
replaced14.3415 Light 3D Headrest 2 Switch
new14.3515 Light 3D Headrest 2 Switch Flex

Table Mounts / Table Clamps / Light 3D

20202021
14.4001 L3D TC 1AK
14.4051 L3D TC 1QS
replaced12.1780 TC L3D 1QS SLS
14.4002 L3D TC 2AK
14.4052 L3D TC 2QS
replaced12.1781 TC L3D 2QS SLS
14.4003 L3D TC 3AK
14.4053 L3D TC 3QS
replaced12.1782 TC L3D 3QS SLS
14.4101 L3D TC 1AK U
14.4151 L3D TC 1QS U
replaced12.1783 TC L3D 1QS UDS
14.4102 L3D TC 2AK U
14.4152 L3D TC 2QS U
replaced12.1784 TC L3D 2QS UDS
14.4103 L3D TC 3AK U
14.4153 L3D TC 3QS U
replaced12.1785 TC L3D 3QS UDS