consultation procedure

I’ve done a little bit of research over the past few days and my current thinking is this (please be aware this is all educated guesswork):
Vitrogro ECM is a synthetic scaffold which seems to contain glycoproteins and insoluble phase growth factors. It seems that it is absorbed by the body as healing occurs and is replaced by the body’s natural ECM.
Reference: TIS website investor presentation http://www.tissuetherapies.com/uploads/Investor%20presentation%20-%20January%202012.pdf

It appears that VG ECM is a device when one looks at the table of device rules and that the question here is simply one of classification. IMO the rule which is used is simply a vehicle to arrive at the classification of the device as Class IIa, Class IIb or Class III.

Reference: Device table at: http://www.ce-marking.org/Guidelines-for-Classification-of-Medical-Devices.html

This document (particularly the coloured flowchart) shows the pathways different classifications follow to approval. Interestingly it appears the manufacturer has a lot of choice in determining the pathway.

Where we may be seeing a hurdle at the moment is whether VG ECM is a “Device Incorporating an Ancillary Medicinal Substance”. Maybe BIS can’t quite work this out and have referred to MHRA to be sure. If it is so classified then BIS are required to “Notified Bodies will need to consult with one of the drug regulatory bodies within the EU or the European Medicines Agency (EMA).”

The following paragraphs seem to be helpful in determining where we are at the moment:
1.1 Purpose of the consultation
For devices incorporating, as an integral part, an ancillary medicinal substance, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the Competent Authorities designated by the Member States on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device.
The term ‘Competent Authority’ is used in this document to represent such a competent body within the meaning of Directive 2001/83/EC, and indicates the authority responsible for the evaluation of applications for medicinal products being placed on the market.
The aspect of “usefulness” relates to the rationale for using the medicinal substance in relation to the specific intended purpose of the device. It refers to the suitability of the medicinal substance to achieve its intended action, and whether the potential inherent risks (aspect of “safety”) due to the medicinal substance are justified in relation to the benefit to be obtained within the intended purpose of the device.
4
By means of the consultation process the Competent Authority may make available relevant information concerning risks related to the use of the substance (eg resulting from pharmacovigilance). The Competent Authority will inform the Notified Body of its opinion, taking into account the manufacturing process and the data related to usefulness of incorporation of the ancillary medicinal substance.
The Notified Body should take into account the opinion of the Competent Authority and use its judgement to either approve the drug/device combination, after consideration of all aspects of risk/benefit in the intended or expected use of the product, or alternatively to reject the product.

Reference:
http://www.mhra.gov.uk/home/groups/es-era/documents/websiteresources/con076011.pdf

Unfortunately if the above is the consultation which is taking place at the moment then it can take anywhere from 90 to 210 days.

If someone could check my research that would be great. I repeat that this is based on a lot of supposition and educated guesswork.

Rev