The MHRA have issued an alert for Roma rollator models 2320, 2340, 2462 and 2463 with serial numbers beginning TVD1002 & TVD1003. The alert concerns fitting of brake extension handles to ensure the brakes meet the standard required for the force needed to lock them. Although not of direct interest to panels we often get involved with Rollators so it is worth knowing about this alert which can be found at :-http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con120255.pdf
For some time now how the Medical Devices regulations 2002 (SI 2002/618) affects Remap jobs has been unclear. Following on from a recent interpretation of the meaning of the key phrase “place on the market” of the same phrase in the General Product Safety Regulations 2005 (SI 2005/1803) it is now our belief that because Remap never charges clients for devices we make the Medical Devices Regulations do not apply to any work done by Remap.
A proportion of Remap tasks involve the making or modification of “Medical Devices” as defined by the Medical Devices Regulations. From time to time the MHRA, who are responsible for regulating medical devices, post information of interest to Remap. If they do we will publicise it here.