On 23 September 2011 the draft of the e-labelling regulation that I wrote about earlier was discussed in the comitology committee for the Medical Devices Directive. I received the text of the amended draft regulation from the European Commission’s services this morning. There were some very minor modifications to the document, as you can see in this compare document.
Apart from some corrections of lay-out, there are two corrections of relevance:
First, there was a minor modification to the way that the instructions for use could be obtained. Rather than the general obligation on the manufacturer explain how and when the instructions for use can be obtained, this explanation must now be given in the paper IFU (see article 6 (3) (d)).
Secondly, the date as of which the regulation will apply is now known. Although it looks like the regulation will still enter into force end of this year, it will apply as of 1 March 2013. With this date manufacturers have a clear horizon for planning of implementation of e-labelling.
Not all companies are happy with this and the general feeling that I perceive from my contacts in the medical devices industry is that this proposal is a big disappointment first and foremost because of the very limited scope of application. Also, there is fear of borderline problems: for example, the concept of ‘fixed installed devices’ in article 3 (1) (c) is less than clear and makes the situation of devices that used to fixed becoming mobile (like CT scanners, X-ray devices) very unclear. I hear a lot of criticism about the manufacturer’s one-sided obligation to do risk management to ascertain if a hospital can handle e-labelling. This is of course a moving target because hospitals are normally not at all amenable to giving the manufacturers any degree of control over and full insight in risks at the hospital side in this respect. That makes risk management a moving target and basically a mission impossible, not to mention an additional regulatory requirement that is not imposed by the Medical Devices Directive.
And, as last big criticism: why so long after the US permitted e-labeling (10 years ago)? If the EU wants to keep its medical devices framework as innovative as it claims it is and is just as good as that of the US, items like this really need to keep up with developments. This is likewise true for software – also in that respect the US is way ahead of the EU in guidance for the industry.