The DIA Euromeeting in Geneva was an excellent opportunity to meet a number of the regulators involved in the process of the Recast of the EU medical devices directives. Since a lot is going on on a high level and it is still not clear which way the Commission will go on a number of very general systemic points, I thought it would be nice to cover a number of very interesting points I picked up about combination products that governments will be pushing for to be included in the Recast.
Regulation of combination products will become more and more important as products develop from combining technologies to converging technologies, a trend that is very apparent in companion diagnostics.
For that reason the Dutch government representative advocated the setting up of a supra-directive borderline committee, much like the FDA’s Office for Combination Products. A multi-disciplinary team of experts could administrate an integrated consultation procedure for combination products based on the principle mode of action of the principle intended purpose of the product. To make this possible, the medicinal products directive would need to be adapted to include a consultation procedure for a medicinal product incorporating a medical device (because the medical devices directive already has a procedure in Annex I, point 7.4 for medical devices incorporating a medicinal product).
The government will be pushing for the consultation procedure for medicinal products incorporating a medical device and the ‘supra-directive borderline committee’ as these are two points high on the wish list for the Netherlands to be included in the Recast. As I hear from sources involved in the Recast project, end of this week agreement will be reached on the high level policy points that the Commission will subsequently take on board for the proposal that is scheduled to be made public beginning of 2012.