< 1 min reading time Dear fellow professional, According to MEDDEV 2.1/1 and Directive 93/42/CE, the intended use of the accessory must be such as to enable a device to be used in accordance with its intended use, so in the guidance are shown examples of accessorie: But, if a machinery is meant to “make” a medical devices, and declared as such by the manufacturer, can still be considered an “accessory” and in need of the CE mark as for medical devices? Thank you source: https://www.linkedin.com/groups/2070960/2070960-6066195282742304770 Marked as spam  Posted by Asked on October 31, 2015 8:00 am 38 views |
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 Private answer Karen Boyd, ASQ CQA If by "make" you mean manufacturing equipment / processing to create or build a device, I would say that's not an accessory. Unless the machinery is required to assist in or be dependent on for the intended use of the device, it's not an accessory. The examples cited in the directives all have some function to assist in the preparation, use, and reprocessing of medical devices. Marked as spam | |
 Private answer Marco CATANOSSI Yes, it seemed to me rather philosophical... Usually cnc machine manufacturer do not focus on a particular product, but if they do and on on a MD... Does not "make" actually enable to use? A machine that model a prosthetic, for instance, and which the manufacturer intended use is exactly that of making a prosthetic, is not essential to make the MD function? Marked as spam | |
| Private answer Karen Boyd, ASQ CQA Marco - Ask yourself these questions, in relation to the prosthetic example: Does the machinery / mold that "makes" the prosthetic accompany the prosthetic to the end-user? Is the machinery / mold that "makes" the prosthetic necessary to use the prosthetic? There can be any number / combination of machinery, raw materials, and processes that "make" or create a MD, (aluminum, steel, plastics, mill, lathe, hone, bending, tubing, molding, etc). However, these machines, raw material, and processes are not the finished product (MD) nor are they part of the MD's end use / intended use. Therefore, these machines,raw materials, and processes are not MD's. A CNC machine would not be purchased by a recipient of a prosthetic, nor would the fit of a prosthetic, everyday use of a prosthetic, or maintenance of the prosthetic require the use of a CNC machine. Hope this helps! Marked as spam | |
| Private answer Karen Boyd, ASQ CQA Does anyone else in the group have input / insight into Marco's concerns? Marked as spam | |
 Private answer Matthew Piska Hi Marco, I agree with Karen on her comments. I've found that the definitions for CE purposes are some of the better ones around in terms of raw materials, components, accessories and your intended use of those definitions, however the guidance documents do leave a lot up to interpretation. As the machinery is being used in the production of the finished device, it is enabling you to convert your raw materials and components into the finished device. It is not (in most cases) enabling the finished device to function to its intended use. A machine that makes, and then takes the device it has made and interacts with the device and patient, caregiver, physician etc to install/use the device. then it would be considered an accessory, however if it is purely used in a factory setting to manufacture the device it is not an accessory. Marked as spam | |
 Private answer Armin Beck All: I agree with Matthew: A machine that manufacturer a medical device is not considered a device and or accessory. An accessory with respect to the MDD is typically a medical device that is needed to enable a medical device to work. E.G. Gel need during ultra sound. However, in certain events machinery needs to be validated. Hope that helps. Armin Marked as spam | |
| Private answer Marco CATANOSSI Thank you all for yours sensible insight. The interpretation is clear and sound. I definitely agree with you. Marked as spam | |
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 Private answer Floris Boele further to the comments above: Equipment that makes/manufacturers a Medical Device is never considered a Medical Device or an accessory to the Medical Device as it is not part of the intended use of the Medical Device. Hope this helps. Marked as spam | |
| Private answer Matthew Piska Floris, that is not necessarily true based on the definition of accessory. Based on definitions and guidance, an accessory can enable the device to perform its intended use, support the device in its intended use or augment the intended use of the device. If the equipment that makes the device, also fits the device to the patient or the caregiver then uses the equipment directly to aid in how the device works it would be considered an accessory. Whilst these would be very specialised and niche pieces of equipment, and completely different to any equipment in a factory setting that manufactures a device that is then shipped to the end user, it is too general to state that equipment that makes a medical device is never considered a device or accessory itself. Marked as spam |
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