Mediqol

Now that’s an obvious statement to anyone who is familiar with the amending directives but I’ve read a couple of articles lately which reinforce the point and suggest that the alternative “literature route” is going to be even more difficult to justify than perhaps originally envisaged.

A recent article published in Clinica and written by NSAI (National Standards Authority of Ireland) outlined what they expect manufacturers to be able to demonstrate if they want to obtain a CE mark for high risk products via the literature route. NSAI have specifically said that:

1. they expect the products technical characteristics to be very similar to the product referenced;
2. that biologically they expect the products of a manufacturers products to be the same as the product referenced; and
3. that the product should be clinically equivalent in that it is to be used on the same type of end user and have the same access point or application.

Given Notified Bodies will be expected to interpret and apply the amending directives in a similar fashion I think we should assume that all Notified Bodies will be taking this approach.

So what are the implications for manufacturers of Class III devices? Well time to market is obviously going to be longer and more expensive if manufacturers are forced down the investigation route. I think we’ll also see an improvement in the quality and depth of clinical evaluations produced by manufacturers seeking approval by this route. Well they’ll have to if they are going to have a chance of being accepted!

For advice and guidance on how this might affect any of your products please email jane.arnold-round@mediqol.com or Kevin.webb@mediqol.com