Regulatory Open Forum

Go to Rule 4 and all the other rules.

The diagram you attached is misleading because it implies the rule based classification system is serial, i.e., after finding the first applicable rule, stop. However, this is the wrong approach. Annex VIII(1.7) says, "The manufacturer shall take into consideration all classification and implementation rules in order to establish the proper classification for the device."

Notice that the rules convert device classification attributes to a rule. More than one rule could apply.

Notice the structure of the rules. There is a rule number, a paragraph, subparagraphs, and indents. Starting with Rule 1, go through all the rules to determine whether or not the rule applies. If not mark it as N/A. If a rule applies record the class and the rule number, paragraph, etc.

When you finish, review the classes identified and select the highest class. That is the device class.

The next step is to select a conformity assessment path. Got to Article 48. This a rule based system which uses the conformity assessment attributes to determine the available conformity assessment paths.

Start with Art. 48(3) and go through each section to Art. 48(10). If the section does not apply, make it as N/A. If the section does apply, including the attributes in the various paragraphs, note the allowable conformity assessment path and other requirements, e.g., Directive 2001/83/EC may apply.

Understand the allowable conformity assessment paths and determine the best fit for your company and device.

Go to Rule 4 and all the other rules.

The diagram you attached is misleading because it implies the rule based classification system is serial, i.e., after finding the first applicable rule, stop. However, this is the wrong approach. Annex VIII(1.7) says, "The manufacturer shall take into consideration all classification and implementation rules in order to establish the proper classification for the device."

Notice that the rules convert device classification attributes to a rule. More than one rule could apply.

Notice the structure of the rules. There is a rule number, a paragraph, subparagraphs, and indents. Starting with Rule 1, go through all the rules to determine whether or not the rule applies. If not mark it as N/A. If a rule applies record the class and the rule number, paragraph, etc.

When you finish, review the classes identified and select the highest class. That is the device class.

The next step is to select a conformity assessment path. Got to Article 48. This a rule based system which uses the conformity assessment attributes to determine the available conformity assessment paths.

Start with Art. 48(3) and go through each section to Art. 48(10). If the section does not apply, make it as N/A. If the section does apply, including the attributes in the various paragraphs, note the allowable conformity assessment path and other requirements, e.g., Directive 2001/83/EC may apply.

Understand the allowable conformity assessment paths and determine the best fit for your company and device.

I didn't try to classify your device, because I wasn't sure I had enough information. However, if you send me the list of rules, paragraphs, and indents that apply I'll be happy to review it.

One you determine the device class you then need to determine the available conformity assessment paths. This is where you might find addition requirements based on device attributes.

The Class from Annex VIII will not change, but the activities to demonstrate may change based on the "conformity assessments". If you send me your decisions from the classification article, I'd be happy to look at them as well.

Go to Rule 4 and all the other rules.

The diagram you attached is misleading because it implies the rule based classification system is serial, i.e., after finding the first applicable rule, stop. However, this is the wrong approach. Annex VIII(1.7) says, "The manufacturer shall take into consideration all classification and implementation rules in order to establish the proper classification for the device."

Notice that the rules convert device classification attributes to a rule. More than one rule could apply.

Notice the structure of the rules. There is a rule number, a paragraph, subparagraphs, and indents. Starting with Rule 1, go through all the rules to determine whether or not the rule applies. If not mark it as N/A. If a rule applies record the class and the rule number, paragraph, etc.

When you finish, review the classes identified and select the highest class. That is the device class.

The next step is to select a conformity assessment path. Got to Article 48. This a rule based system which uses the conformity assessment attributes to determine the available conformity assessment paths.

Start with Art. 48(3) and go through each section to Art. 48(10). If the section does not apply, make it as N/A. If the section does apply, including the attributes in the various paragraphs, note the allowable conformity assessment path and other requirements, e.g., Directive 2001/83/EC may apply.

Understand the allowable conformity assessment paths and determine the best fit for your company and device.