CE Marking (Conformité Européene) / CB Scheme | Forum profile

Quote: It may well be that normal EC regulatory practice is to regard power cords as not devices and not accessories, but in my interpretation, that is not what the MDD says should be done. Agreed. But please keep in mind that the classification scheme is related to the intended use of the medical device. It is a little difficult to classify "general type" accessories as such.

Ok, but I have another doubt. A navigation system uses a infrared ccd stereopotogrammetric camera. A double crown of infrared led is used to enlighten a cluster of passive marker fixed to the bone of the patient during the sugical time. The cluster of marker reflect the infrared light and the ccd camera acquires the position of the clauster of marker. Must this infrared light to be considered as an energy from the medical device to the...

Can any medical device folks help with this one? My Thanks in advance!

Quote: Originally Posted by Asherlee To all, In companies where I worked previously, our NB gave us a MDD/CE certificate which consisted of a generic “product category” followed by an addendum which listed the specific company products approved for CE marking. The NB of the company where I work now, has issued CE certificates with only the generic “product category”, but no list of specific company products. We want to market a new Class...

When listing electrical standards on DoC and Part A of Technical File, little confused on best or correct way to list. Currently we have and are tested to comply with: IEC/EN 60601-1 IEC/EN 60601-1-2 UL 60601-1 CAN/CSA C22.2 601.1-M90 CAN/CSA C22.2601.1B-98 Should they all stay or just the IEC/EN standards? Thanks for any input?

Hi Subbu, Thank you very much for the information. however, based on afew customers request, we would like to include both CE Marking and IVD symbol in Certificate of Analysis and Certificate of Compliance. How abt the Warranty cards issued by the manufacturer and User Bulletin (this is just a bulletin based on Waste Electrical/Electronic equipment, EC Directive)?? Do we need to have CE and IVD on them?? Any more answers plz!! Regards Sreenu

Thank you all for your replies and the answers. This was very helpfull! Kind regards, DeVos

Quote: Originally Posted by Medsearch What is the difference between certificate of analysis (CoA) and certificate of compliance (CoC)?? Certificate of Analysis (COA) is a record of quality control testing performed for the product/ material which indicates whether the product or material conforms or not. The Certificate of Compliance (COC) is a record that everything which was performed as a part of manufacturing that material or product has...

Dears, I am currently working on a project. It is basically a air compressor driven by a normal diesel engine. It is a mobile unit. I am using an electronic controller which starts and stops the engine. Apart from start and stop the controller will monitor the pressure and temperature status of the compressor and the diesel engine and trips the engine in case of abnormality. In my opinion this electronic controller is the only component that...

Hello, not an expert but here my guesses (under the point, that I'm not sure how your CE marking will be in total) The total package must have at the end a CE marking, it goes absolutly with the EG requirements. So for this you need a risk analyises for all components, so you can devide your equipment in the parts which are under EMC or not, but in my opion as long as the working of the machine can be influencec by EMC (for example the...