So, it took a while but the devices have finally landed. During the EPSCO council of 1 December it was confirmed that the medical devices policy has indeed moved to DG ENTR. I have also heard Commission officials tasked with medical devices at DG SANCO say they are in transition now.
It also became clear that the ambitious Italian pre-pack first reading plan had failed because no common position was reached. The progress report for the meeting was approved and the Italian presidency expressed the hope that the Latvian presidency can build on its work.
The Dutch in 2016
Since it became already clear that the Latvian and Luxemburg presidencies do not have great ambitions in this matter, the scenario that I have sketched that the Dutch presidency in the first half of 2016 will try to make a difference becomes more and more likely.
As you can see in the progress report, there is still a lot of work to be done. Even though all chapters of the proposed regulations have been tossed repeatedly like a regulatory salade niçoise (every chapter and every annex of both proposals (20 chapters, 187 articles and 29 annexes) have been discussed two times each at the end of the Presidency), no agreement was reached and a number of political bones of contention remain, which include:
- Aesthetic devices;
- Ingested products;
- Reprocessing of single-use devices;
- the Unique Device Identification System (“UDI”);
- Mechanisms for surveillance and appointment of the Notified Bodies responsible for conformity assessment of Medical devices and In vitro diagnostic medical devices;
- the Scrutiny mechanism for certain high risk devices;
- Clinical investigations;
- Post-Market Surveillance;
- Tasks of the proposed Medical Device Coordination Group; and
- Role of expert panels and reference laboratories.
The progress report will show you exactly where the differences are for each of these categories. The politically most difficult ones are MDCG, UDI, notified bodies’ role and post market surveillance.
One of the interesting statements during the EPSCO council was the statement of the Dutch delegation that they thought that with all the amendments on the table it would be a very good idea to revise the impact assessment underlying the original proposals. I cannot applaud that enough, because as I have argued time and again, the so far fact-free amendments of the Parliament should have a basis in reality and it should be made clear what these amendments mean for industry, costs of healthcare and the patient/payor. It would be very interesting to see what the Parliament’s amendments amount to when they are assessed for impact. It will probably show, for example, that the hazardous substances amendment will add nothing in terms of safety but will only cost a lot in terms of compliance for compliance sake exercises.
Prediction for 2015
My prediction for next year (2015) is a year of quiet diplomacy in the background to pre-cook a final agreement during the Dutch presidency. It may happen that the trilogue finally kicks off during the last half of 2015, now that the Parliament voted to be ready for it on 5 November 2014. 2015 will also be the year of eHealth and mHealth, with the Commission starting to translate the feedback to the Green Paper on mHealth into policy actions, part of which may be fed back into the discussions regarding the medical devices regulations, e.g. on the definition of ‘medical device’. The Council and the Commission may also realise how ill-equipped the current proposals for the medical devices and IVD regulations are to deal with modern devices as a service, standalone software and the nexus with
- the (draft) General Data Protection Regulation that will impose design requirements for IoT enabled medical devices via its privacy by design and default regime and
- the (draft) NIS directive that will impose cyber security and breach notification requirements.
Also, the unannounced audits will become established practice and the notified bodies will continue to increase their clinical evidence requirements as a result of the joint audits under the Joint Action Plan.
Finally, new production techniques like 3D printing will need to find a place in the regulations one way or the other, or we will need to accept that from a regulatory perspective there is no difference.
So how to keep track of all that?
Here are some suggestions
for the end and beginning of the year, to stay on top of all these developments:
- 9 December MD Project seminar on active devices including software, in Vianen, the Netherlands, will cover information security and cyber security for devices, among other things;
- 11 December Eucomed event on unannounced audits and clinical requirements, very topical and of course conveniently in Brussels, with speakers that are close to the source (or are the source) – also open to non-members and very much worth your while in terms of information that you get nowhere else and networking;
- 27/28 January 2015 Informa’s European Medical Devices Regulation conference in Brussels, a good conference to get a complete overview of all that is happening in medical devices in the EU in one go; and
- 4 February 2015 Axon Lawyers seminar on 3D printing and biofabrication (preliminary program)in Amsterdam, a seminar on legal and regulatory aspects of new production techniques with guest speakers from DSM Biomaterials and Materialise, two of the moving and shaking companies in these fields.
I hope to see you at one or more of these very worthwhile events!