White smoke again! After a long summer following the partial general approach on 19 June in which there was not much to report the Council now reached a general approach on the MDD and IVDR on 5 October, endorsing its negotiating position on the medical devices and in vitro diagnostic medical devices draft Regulations. The Council’s decision allows the Luxembourg presidency to start the ‘Trilogue’ talks with the European Parliament and the Commission with a view to reach an agreement as early as possible – the first meeting took place on 13 October, but since the Council is not publishing these reports, we don’t know the result publicly yet.

I know what they did last summer

What happened over the summer? Remember, we only had a partial general approach before the summer. In the words of the Council in the A item note:

“5. At its meeting on 23 September 2015, the Permanent Representatives Committee (Part 1) examined the draft Regulation on medical devices set out in document 12040/1/15 REV 1+ ADD 1 and the draft Regulation on in vitro diagnostic medical devices set out in document 12042/15 + ADD 1 and noted that the Working Party on Pharmaceuticals and Medical Devices had reached agreement at technical level on recitals that reflect the contents of the two draft Regulations and on corrections of technical inconsistencies.
6. At that meeting, it was noted that all delegations apart from the German delegation could support the two texts referred to in Point 5. A qualified majority in favour of the draft General approaches therefore exists.”

The regulations with recitals (those were missing on 19 June) are now public:

MDR + annexes (over 400 pages together)

IVDR + annexes (over 350 pages together)

There have been some later very technical iterations that modified details between these texts and those finally agreed as general approach, see e.g. here for MDR, MDR annexes, IVDR and IVDR annexes. However, those texts are not public.

German objections

The story doesn’t tell whether the Germans overcame their objections, but this was irrelevant in the end since the qualified majority of member states rallied against them could overrule them and escalate the dossiers to the trilogue. Given that only the Germans were objecting I suspect the issue was with other member states’ tweaking in the German themes, likely reprocessing of single use devices, which many member states have issues with and the Germans are currently already allowing.

The technical corrections and recitals are published now, but the technical corrections in the annexes are not groundbreaking (that’s why they are technical corrections and not substantive ones).

Industry still cautions

Eucomed notes that there are still 5 areas that need attention during the trilogue:

1. The ‘Scrutiny’ mechanism – Redundant with other improvements, but if there, at least make it workable and predictable
2. Clinical evidence – Maintain the Commission’s and a much simplified Council case-by-case approach and get the definitions of clinical data and clinical equivalence scientifically sound
3. Re-use of single-use medical devices – Ensure a single high harmonised level of safety across the EU as per Commission proposal with hospitals and subcontractors appropriately covered
4. Hazardous substances – Support the feasible, scientific and proportionate approach of the Commission
5. Unnecessary added complexity and disproportionate measures – Strip out unfeasible, disproportionate or duplicative requirements and reverse unjustified re-classifications

These points are clarified in a convenient position paper that you can find here and which provides alternative proposals as stakeholder input for the trilogue.

EDMA provided a similar position paper, flagging 6 areas in the IVDR that need attention in the trilogue:

1. Clinical Evidence requirements must be adapted to the specificities of IVDs, and be broadly appropriate for all IVDs, not just companion diagnostics and interventional technologies, which make up only a few percent of all IVD products. Acknowledging this is especially important when defining requirements for studies, post-market assessment, and criteria for assessment of IVDs.
2. Conformity Assessment should reflect the risk-based approach with proportionate regulatory controls increasing alongside the risk class.
3. Quality Management Systems should establish only those requirements applicable and feasible for IVDs, as opposed to those applicable for other health technologies. In addition, specific IVD technology and requirements (e.g. self-tests) should adequately reflect the nature of these devices.
4. The Companion Diagnostics definition is not specific enough and should only include those IVDs selecting patients for a specific therapy. In addition, the mechanism for clinical evidence requirements for companion diagnostics, especially scientific validity and intermediate assessment, must be adapted.
5. Classification principles for IVDs must be consistently applied to ensure a system of controls that is proportional to the risk class of the IVDs, while at the same time adhering to the internationally agreed classification scheme.
6. Labelling Requirements need to be clear and uncluttered, focusing on the information that is essential for the safe use of the IVDs to deliver relevant results and adhering to globally harmonized labelling requirements.

The EDMA position paper clarifying these areas can be found here.

What’s next?

The trilogue will unfold during the Luxemburg Presidency during the last half of 2015 and if this all goes well, there will be a compromise text that the Dutch presidency will be able to shepherd in becoming law somewhere in the first half of 2016.

As industry’s reactions show, things may still shift in the positions as each of the institutional actors has their hobby horses in the respective texts, like e.g. reprocessing for Germany, centralization of governance and market surveillance for the Commission, PMA on the extremely regulated end of the spectrum for the Parliament and national exemptions for this, that and the other thing by the Council.

But that’s not all

Meanwhile, the General Data Protection Regulation and the NIS Directive are also nearing completion of their respective trilogues. As I have blogged in the past, both of these regulations (especially the GDPR) will have severe consequences for how (international) medical devices companies do business and design their devices and IT solutions. Good luck with your implementation for these two as well.