NZ company - tissue repair product, page-11

This is like Ground Hog Day.

1. From the NRMA on classifications.
"It is for the manufacturer to initially determine the classification of their product(s). This will allow them to select a notified body (if required) with the ability to carry out the appropriate conformity assessment procedure. It will then be for that notified body to confirm the classification arrived at by the manufacturer before embarking upon the process of conformity assessment."
I hope that is clear enough.\

2.
Question: Why was Medical Device Rule 8 chosen for the regulatory submission instead of Device Rule 13?
Answer: Classification of VitroGro® ECM as a Class III Medical Device under Rule 8 was determined by the Notified Body and advised to Tissue Therapies Ltd

Looks to me like someone's twisted the facts here for their benefit. I think its called Buck Passing. Its clearly the responsibility of the manufacturer to choose the classification. If there is a disagreement on the classification then the NRMA says, "In the event that the manufacturer and the notified body cannot agree on the classification, either party can refer the matter for a decision to the competent authority that designated the notified body. If doubt still exists, the European Commission, acting in conjunction with a regulatory committee composed of experts from the member states may be approached for a ruling. Similarly, the European Commission, in conjunction with the regulatory committee, may adapt the rules if experience shows this to be necessary."

Plenty of scope to make sure you get it right.

Looks like TIS wanted the classification 8 and BSI was prepared to do the business. Apparently they had done similar type products before under this ruling.

The statement by TIS on 30-10-2012 said it like this.
"Biomedical company, Tissue Therapies Limited (ASX: TIS) has been notified that the Medicines and Healthcare products Regulatory Agency (MHRA) review of VitroGro® ECM has confirmed classification of VitroGro® ECM as a Medical Device Class 3, but under Device Rule 13 instead of Device Rule 8, as was agreed earlier with the Notified Body."

Notice the last line, "as was agreed earlier with the Notified Body." That does not say "told by the Notified Body." The devil is in the detail.

I hope there are enough "FACTS" there for you dinner boys. Sorry if its spoiled it a little. Let me repeat it one more time.
. From the NRMA on classifications.
"It is for the manufacturer to initially determine the classification of their product(s)."