Just before last weekend the final e-labelling regulation was published in the Official Journal of the EU, see right here. As you will see when you run a compare (like I did) there is absolutely no change compared to the last version that was available among stakeholders. For that reason, I will not repeat all the things I wrote about it here and here.
Suffice to say that the criticism voiced earlier is now set in stone as far as I am concerned because the industry will have to live with this piece of legislation that I would label as a truly missed opportunity for the EU.
Just to summarise for those who do not feel like reading my earlier discussion of the regulation, it only applies to
(a) active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device;
(b) implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device;
(c) fixed installed medical devices covered by Directive 93/42/EEC;
(d) medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use; and
(e) stand-alone software covered by Directive 93/42/EEC.
It requires manufacturers to conduct a risk assessment about the use of e-labeling for the device concerned that must have a positive outcome and involves assessment of the circumstances under which it is used, which must be updated based on information gained in post marketing surveillance . Finally, there are a lot of labeling specifics, both for the e-IFU itself and for the device concerned – want detail? Read the discussion about those here.
So, in the end – be careful what you wish for for manufacturers with devices in scope, disappointment and missed opportunity for all others as the scope of devices (to me and to others) seems to have been established rather arbitrarily. I could live with the criterion that the devices concerned should be used by professional users, but why the limitation to implantables and their accessories, fixed equipment, capital equipment with screens and standalone software? This proposal could have been so much better, for example by allowing central storage of all paper manuals in a central repository in medical institutions under the responsibility of the institution itself with e-IFUs available throughout the institution, which is what already happens in practice anyway. That would have been the way to go, as the manufacturer can presently not control how the hospital uses the IFUs in the first place – and now manufacturers must do a risk assessment on how the hospitals use them? Most of my clients inform me that the hospital tosses them in the waste immediately and asks for PDFs on a suitable storage medium or does not even go that far and just trusts they will be able to find it on the manufacturer’s website if needed. The proposal goes completely against all developments currently going on that only lead to healthcare professionals accessing more and more data electronically from handheld or bedside devices, so just to repeat myself: a truly missed opportunity for the EU.