Archive for July, 2009
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
Borderline Medical Devices – Guidance Document
MEDDEV 2. 1/3 concerning borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative has been updated to take account of the changes introduced by the 2007/47/EC amendments and is available to download here.
This guidance document is essential reading for manufacturers of medical devices intending to CE mark combination products that incorporate a medicinal substance or a human blood derivative.
Mandatory compliance with 2007/47/EC – Only 8 months to go!
I recently gave a presentation on the impact of 2007/47/EC to about 30 medical device manufacturers. I think it went ok, no one seemed to be asleep at the end!
There are now only eight months to go until compliance with the new MDD is mandatory and we are starting to see more and more companies asking for help with clinical evaluations; the requirement for which are significantly increased by the directive. There are 15-20 other significant amendments which you can find summarised in the presentation here.
Proposed new regulatory requirements for IVD’s in Australia
The Therapeutic Goods Administration (”the TGA”) has recently published an overview of its intended new regulatory requirements that will apply to in vitro diagnostics. Having read through the documentation it appears that the major points are:
- IVD’s will be regulated as a subset of medical devices and will be subject to a risk based classification system (4 classes)
- Class 1 products will be self-certified by the manufacturer. The TGA will accepted certification from a recognised regulatory body for Class II and III products. Class IV products (high public health risk) will require a TGA conformity assessment
- Once a product is approved and being sold in Australia manufacturers will have post market responsibilities
- There will be a transition period of four years
Mexico
We’ve just finished a project with a client registering a device in Mexico and whilst a post on the full Mexican system might end up at 10 pages I thought it might be useful to provide a very brief analysis of the Mexican regulatory system!
The Federal Commission for Protection against Sanitary Risks (COFEPRIS) is the regulatory agency that acts under the authority of the Mexican Ministry of Health.
The system for medical device regulation is similar to many around the world in that it is based on classification and risk (I-III) with more information and evidence being required for products in the class III category. Approval times vary upon the classification and can take up to 6 months.
For assistance registering your products in Mexico please contact sarah.ramsay@mediqol.com
