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View Full Version : MDD and CE Mark Registration - What will the technical expert look for? JohnKlus 11th January 2006, 04:46 PM We are a small Medical device manufacturer in the process of getting approved to ship to Europe under the CE mark. We made it through the ISO 13485 audit and microbiologist but I am confused on what the technical expert will be looking for. Can anyone who has gone through it give me some help? Thanks. John Al Rosen 11th January 2006, 05:25 PM We are a small Medical device manufacturer in the process of getting approved to ship to Europe under the CE mark. We made it through the ISO 13485 audit and microbiologist but I am confused on what the technical expert will be looking for. Can anyone who has gone through it give me some help? Thanks. JohnThey will be looking at how you have fulfilled the essential requirements. Look at the checklist in the thread, Technical Files - Please explain differences and what information would be included. (http://elsmar.com/Forums/showthread.php?t=8658) Roland Cooke 14th January 2006, 07:10 AM Deep emphasis on: Claims - do you have evidence that your product performs as described for each of these individual claims? First, be absolutely clear what your claims actually are.... The evidence must be summarised and evaluated - thus a simple stack of clinical papers is no good. The evidence must be comprehensive - include negative information if it exists - and explain why such is not a show-stopper. Technical - Essential Requirements, as described above. See the relevant NB-MED for additional guidance. Safety - Risk Analysis (as per ISO14971). Note that the risk analysis must feed into the clinical analysis - you need to demonstrate that the benefits outweigh the identified risks. vramc 16th January 2006, 01:03 PM Clause 4.2.4 of the standards ISO 13485:2003 specify the following: Records are to be retained for at least the period of time equivalent to the expected life of the device. Can anyone explain what is meant by the "expected life"? Is it the validity period of the IVD -such as kits or the lifetime of the product as manufactured Al Rosen 16th January 2006, 02:07 PM Clause 4.2.4 of the standards ISO 13485:2003 specify the following: Records are to be retained for at least the period of time equivalent to the expected life of the device. Can anyone explain what is meant by the "expected life"? Is it the validity period of the IVD -such as kits or the lifetime of the product as manufacturedI believe its useful life or the time expected to function within it's specification. JohnKlus 16th January 2006, 03:14 PM Dear Al and Roland: Thanks for the help. I will continue to work on my paperwork. One last question, in regards to the authorized representative: Do I have to have a formal agreement available for the auditor? Thanks again. John Al Rosen 16th January 2006, 03:26 PM Dear Al and Roland: Thanks for the help. I will continue to work on my paperwork. One last question, in regards to the authorized representative: Do I have to have a formal agreement available for the auditor? Thanks again. JohnYes, unless you have some other form of evidence. Did you have something else you could provide as evidence? |
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