Hello Everyone,
My company manufactures drugs of abuse testing products in the immuno assay cassette format. Now they are planning to use an electronic reader to capture the results instead of the user visually reading the results. The device consists of a slot to insert the cassette and a camera inside. Also it comes with some basic software to customize the results. Now, what requirements would CE have ? Our regular drugs of abuse testing products are already CE marked. Do we need to satisfy any IEC, UL or environmental standards? Any other standards ? Please advise.

Thanks for your time,
manoj

Hello Everyone,
My company manufactures drugs of abuse testing products in the immuno assay cassette format. Now they are planning to use an electronic reader to capture the results instead of the user visually reading the results. The device consists of a slot to insert the cassette and a camera inside. Also it comes with some basic software to customize the results. Now, what requirements would CE have ? Our regular drugs of abuse testing products are already CE marked. Do we need to satisfy any IEC, UL or environmental standards? Any other standards ? Please advise.

Thanks for your time,
manojFor a start:
IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance(there is a harmonized UL version for the US)
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
60601-1-4, Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
60601-1-6, Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: UsabilityYou should look at the harmonized standards for the IVD directive (http://www.newapproach.org/Directives/DirectiveList.asp)and check the FDA recognized consensus standards database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) for your product.

Lastly, check with your notified body. They have the final word.

I took a look at these standards and I have another question.
Its my understanding that these are not requirements to get the CE mark. Most sections in the standard were not applicable to the device in question. So can I self declare and conduct risk analysis, FMEA and document the conformity to the standards you mentioned (although most sections are not applicable) ? Should I be fine then?

I took a look at these standards and I have another question.
Its my understanding that these are not requirements to get the CE mark. Most sections in the standard were not applicable to the device in question. So can I self declare and conduct risk analysis, FMEA and document the conformity to the standards you mentioned (although most sections are not applicable) ? Should I be fine then?You can't self declare with the MDD, it requires a notified body. The standards are the means by which you show that you meet the essential requirements. That is what is required and these standards are a recognized method. As I stated in my previous post, your NB has the final determination so check with them since they will be reviewing your technical file.

Sorry to resurrect an old thread, but it is nearly identical to my current question. Would the reader of the rapid tests fall under the MDD or IVDD? Because it is "used in vitro for the examination of specimens derived from the human body", should it then fall under the IVDD? And in this case can it be self declared as a class I device? I've never had to deal with an electronic reader device before.

It's all about the "intended purpose" which defined by the legal manufacturer.

Please refer the following definition to determine whether your device under the IVDD directive: (For me it's more close to IVDD, if it's not used for legal issue but some medical purpose clearly defined by manufacturer, your can refer the MEDDEV 2.14, subclause 2.3 )

'in vitro diagnostic medical device` means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

- concerning a physiological or pathological state, or

- concerning a congenital abnormality, or

- to determine the safety and compatibility with potential recipients, or

- to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. 'Specimen receptacles` are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

If you decied to make it as a IVDD device, then if your device is neither List A/List B from Annex II of IVDD nor self testing device, then we don't need a notified body, you can prepare the technical file and put the CE mark by self declataion.

The harmonized standard for IVDD electronic device, the EN 61010-2-101: 2002 will be considered normally.

Greta

Hi Greta,

Welcome to the Cove :bigwave:

Nice to note that you have jumped right in; keep going :):):)