Posts Tagged ‘europe’
2007/47/EC will force more companies down the clinical investigation route
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
European Commission to push ahead with recast?
In summer 2008 the European Commission revealed plans to “recast” the medical device regulatory framework in Europe (find document here). Following feedback from industry implementation was postponed but it now appears there is a move to pursue the recast.
At a recent device industry meeting in Rome Georgette Lalis, Director of the European Commission consumer products and industry division confirmed that “we will eventually deliver, under the new commission, a broader revision of the medical devices regulations in Europe”. It appears that the commission aims to have the new framework in place by 2015. A lot can obviously happen between now and then but we think one thing is for certain and that is there will be fundamental changes to the regulatory environment for medical devices in Europe over the next five years.
Should the EMEA have medical device regulatory over-sight?
I’ve been catching up on my regulatory reading lately and I’ve come across an article from a device consultant recommending that the European Medicines Agency (EMEA) gets involved in medical device regulatory over-sight (http://tinyurl.com/qghar4). We’ve had a bit of a chat about this internally and we aren’t so sure. Where would it lead? What impact would it have on device approval timelines? What expertise do EMEA have in device approval?
We think the medical device regulatory environment in Europe faces challenges and changes need to be made but we don’t think this is the solution.
