While everybody is starting up again after the summer and had 26 September as first major horizon date in their head (the date on which the Commission has said it will publish the proposed new EU medical devices rules), the EU decided to go ahead and change the rules for (active) medical devices utilising tissues of animal origin in a separate legal instrument, a Commission Regulation.
What is it about?
Commission Regulation 722/2012 concerning active implantable medical devices and medical devices manufactured utilising tissues of animal origin has just been published in the Official Journal of the European Union on 9 August 2012. It replaces the existing requirements contained in Directive 2003/32/EC and provides for procedures required when using tissues from TSE-susceptible animals in medical devices. The Regulation will apply from 29 August 2013. The obligation for Member States to verify that Notified Bodies have the up-to-date expertise to assess the conformity of medical devices in line with Regulation 722/2012) will enter into force on 29 August 2012. The Regulation did not come as a complete surprise (because a publicly available draft version had been shared with WTO members as part of the obligations in the Technical Barriers to Trade committee), although the timing of a Commission Regulation being final and published is always difficult to predict. Furthermore, why couldn’t this subject wait for inclusion in the new Regulation that is supposed to cover both active implantable and ‘other’ medical devices by merging Directives 90/385 and 93/42?
Any important changes?
Yes, at least some, although it is mostly merging of the Directive and the MEDDEV that currently deal with this subject. New is that the instrument is a regulation, which is a logical step in the process of the EU regulating more by directly applicable regulation in the life sciences industry rather than by directive, the latter leaving the Member States too much wiggle room for own interpretation. The new regulation expands the scope by including active implantable medical devices under Directive 90/385. It covers devices utilising tissues of animal origin (non-viable tissues and tissue derivatives originating from bovine, ovine and caprine species, deer, elk, mink and cats, to be precise) and links to Regulation 1069/2009 that provides for rules for sourcing of animal by-products not used for human consumption, as well as to Decision 2007/453 with respect to assessing the risk of the source country.
The general system set up under Directive 2003/32 stays the same (Annex I prescribing specific essential requirements for the devices concerned, some of which are updated and some of which are new), except that the procedure has been streamlined in a way that we may see under the new regulation for high risk medical devices in response to the ENVI complaints that I wrote about here and here. The regulation sets up a system for regulatory fast-tracking of summary evaluation reports regarding use of starting materials that have obtained a ‘TSE certificate of suitability’ from the European Directorate for the Quality of Medicines, based on the ‘coordinating Competent Authority’ model set out in section 6.0 of the MEDDEV. The Regulation provides for a model summary evaluation report in Annex II.
I have heard through the grapevine that the new general medical devices regulation may use a similar system, allowing Member States to comment on the Notified Body’s evaluation of high risk devices prior to CE marking, except if the evaluation shows that the device has been designed and evaluated in conformity with EU standards developed by a body to be appointed for this, perhaps SCENHIR that issued scientific reports on among other things reprocessing of devices in the past and which is now working on breast implant guidelines, or the JRC, the Commission’s inhouse scientific service.
Another important but not so new novelty in the Regulation is that the manufacturer has a positive obligation to collect, evaluate and submit to the Notified Body information regarding changes with regard to the animal tissue or derivatives used for the device or with regard to the TSE risk in relation to the device (a responsible manufacturer would do this already because this was already included in section 8.0 of the the non-binding MEDDEV). If the Notified Body subsequently concludes that such information leads to an increase of the overall TSE risk, the conformity of the device concerned must be assessed again, including the step of involving member states’ competent authorities.
Finally, the Regulation is more prescriptive in the evaluation required for renewal of a certificate by a Notified Body by setting out a minimum list of aspects to be evaluated by the Notified Body.
Of course among the points not discussed in this post there are other interesting details, like the new rigorous process for tallow derivates, copied straight from Annex I of the MEDDEV, so also not that new but now mandatory.
Why couldn’t this wait for the revision?
For two simple reasons, I think. First, it will take quite a while for the revision to trickle through the legislative process and enter into force (three years likely, with another year of transitional period). Second, Commissioner Dalli has in no uncertain terms requested member states to increase market surveillance for medical devices in early 2012. Out of all possible things the Commission does not need another PIP breast implant-like scandal to put another dent in the reputation of EU medical devices regulation, so it must have decided that devices utilising tissues of animal origin had sufficient potential in that respect to warrant regulating them ahead of schedule. Part of the market surveillance increase effort was an appeal to Member States to check if their Notified Bodies were still up to the task. A clear hint to this effect is made in recital 8 and article 4 (1), obliging the Member States to verify that the notified bodies designated to assess the conformity of medical devices manufactured utilising animal tissues have the necessary expertise and up-to-date knowledge to perform this task and to inform the Commission by 28 February 2013 of their findings. It is not excluded that the new revision Regulation will absorb this Commission Regulation by superseding it when it enters into force, so manufacturers should consider starting to plan for that to happen.