Where are we with the MDR and IVDR after the Greek Presidency?
Some time ago I promised you a follow up on the 20 June Council meeting, but I also mentioned that it could wait for a while at the time because the outcome was not that spectacular or even unexpected.
On 20 june the Council had its last deliberation on the medical devices and IVD regulation proposals of the Greek presidency. We’re over to the Italian presidency now, with a new Parliament and a new Commission following the EU elections and the expiry of the mandate of the 2009-2014 Commission.
Where are the member states amongst themselves on these dossiers? A good source is the Dutch Health Ministry’s annotated rather frank briefing for the 20 June Council meeting. That document essentially makes the point that the Member States are still pretty far apart on the two important points discussed at the December 2013 Council meeting: market access mechanism and reprocessing. That was before the 20 June meeting, mind you. As you will see below [spoiler alert!] it seems that this divide has not grown narrower at all.
Since October 2012 the Council has the Working Party on Pharmaceuticals and Medical Devices working to produce compromises for the purpose of a common position to come to a first reading. In the mean time we have spent many happy hours in suspense poring over the stream of documents coming out of the working groups, busily proposing changes and hoping that it makes a difference. The Council has generated proposals on a per chapter basis in order to foster agreement amongst the Member States:
- Chapter I Definitions
- Chapter II and III Economic operators and Identification & Traceability
- Chapter IV Notified Bodies
- Chapter V Classification and conformity assessment
- Chapter VI Clinical evidence
- Chapter VII Vigilance and market surveillance
- Chapter VIII Governance and registers
- Chapters IX Confidentiality, funding, penalties and chapter X Final provisions
These proposals may not be the very latest available, but it is what’s available publicly on the Council’s document service. They continue to be revised and fine-tuned as the Member States do their alignment dance to arrive at a common position that will permit adopting a text in first reading. At the time of the 20 June Council meeting they had been revised almost twice. So far however a common position is not on the horizon, and even a general approach is not in sight for the moment.
During the second part of the Greek Presidency, efforts have concentrated on Chapters IV (Notified Bodies), VII (Vigilance and Market Surveillance) and VIII (Governance), which (according to the Council’s progress report) contain many of the most important innovations compared to the current EU legislative framework for medical devices.
The hangup with Chapter IV (Notified Bodies) is that some Member States are concerned that the procedures could be too burdensome from an administrative and financial perspective. Also, Member States may feel that they have already accomplished a lot under the Joint Immediate Action Plan. that consisted largely of a thorough pan-EU review of the notified bodies accredited for the medical devices and IVD directives.
Chapter VII remains a bone of contention because some Member States want this chapter reinforced so less administrative and regulatory burden can go into market access, like the Dutch and UK. Other Member States are completely against this.
Chapter VIII leads to disagreement because several Member States are not convinced that the MDCG, the intended EU level ‘steering committee’ for the medical devices and IVD regulation will be able to fulfill its tasks for lack of capacity. This is a view shared by many on the outside as well, by the way. Also, some member states are not sure that the reference laboratories (who will undoubtedly be very good at testing) will be able to provide a contribution relevant for regulatory purposes, a view that is also shared on the outside.
Did the 20 June Council meeting change anything?
Not really. At stake were three questions posed in the Progess Report prepared by the Greek Presidency:
- Does the text set out in Annex C [of the Progress Report containing a proposal for Chapter IV on Notified Bodies] constitute a good basis for the further discussion on the provisions regarding designation and monitoring of Notified bodies?
- Are specific provisions on post-market surveillance under the responsibility of economic operators a necessary element to secure an adequate level of protection of patients?
- Bearing in mind the aims of the proposed Regulations, and in view of the resources required, is it desirable to allocate further tasks to the MDCG other than those foreseen in the Commission proposal?
The result was largely a repetition of moves reminding me of the ‘wheelbarrel of frogs’ that we had seen in the previous Council meeting in which all Member States were allowed to give their opinion about the two (then) most important elements of the proposal. I won’t repeat how everyone went everywhere on the proposals and how the IVD regulation was completely ignored again, but here is the median:
- Annex C looks OK for some but still needs substantial work according to others;
- Yes to considering specific PMS provisions in one form or another say most Member States, but which form (because nobody agrees on that)?;
- Several states remain unhappy with the MDCG because they are not convinced it will be able to carry out its tasks effectively.
The meeting concluded that this Presidency has made progress but not enough for Council to adopt a position or even a general approach. Several Ministers and Commissioner Mimica expressed hopes that enough progress can be made in the coming months to achieve a Council position under the forthcoming Italian Presidency. Some proposals were made with different political implications:
- Germany proposed that a parallel group work alongside the Council Working Party during the Italian Presidency; and
- France wanted discussions to be moved from Working Party to COREPER level
This is a sign that the more vocal big Member States want to throw more political weight behind the dossiers in order to progress them, as they are starting to get annoyed with how things are bogged down at them moment. However, Germany and France are not the only big member states and small member states may gang up in surprising opportunistic coalitions.
Italy, as new holder of the Presisdency, expressed its strong will to progress with the file to the best of Council’s combined abilities under the Italian Presidency. In addition to the Greek Presidency’s three questions in the progress report, Ministers were invited to comment on the Commission’ Staff Working Document (SWD) on Implementation of the Joint Plan for Immediate Actions. Not many interesting comments there.
The official version of the moment is that the Council will try to achieve a ‘pre-pack first reading’ by involving the Parliament closely in its discussions towards a first reading, according to the Progress Report:
“Since the examination in the Working Party indicates that delegations wish to make changes to the proposals that do not concur with the European Parliament amendments on all points, interinstitutional negotiations will be needed in order to reach an agreement. Such negotiations could take place before the formal adoption of the Council position at first reading, in which case the European Parliament could approve the Council position without amendments in accordance with Article 294(7)(a) of the TFEU resulting in an “early second reading agreement”.”
And the Council plans to have achieved this in autumn, according to the 20 June meeting press release. This will mean intensive contacts with the new Parliament’s ENVI committee and the new Commissioner for Health (more on that below).
The optimistic Italian Presidency even plans to put the whole dossier to bed signed, sealed and delivered before its Presidency’s end. The Italian optimism I think is completely unrealistic. More realistically, if the pre-pack first reading plan fails (which in the end will really depend now on how much the new Parliament wants to stick to the previous Parliament’s not always well-advised proposed changes to the initial text because the Commission and Council are far closer than the Parliament and the rest), there is the default legislative route of slogging on to a second reading as fallback.
There are rumors however that even this is far too optimistic and that the Member States are so far apart that they will most likely not agree on a common position during the Italian presidency, that it may also not happen during the Latvian presidency in the first half of 2015 as initially thought and that even the Luxemburg presidency in the second half of 2015 may not close the deal. And then the Council has not even started to negotiate with the Parliament and Commission in the trialogue in order to align with a view to a final text. This. of course, is a bad thing to hold over the market with industry in dire need of some predictability of when it should plan to have transitioned to a very far reaching overhaul of EU medical devices law.
New Commission and Parliament
Will the new Commission and Parliament make a difference? As yet we do not know who will be ENVI committee rapporteurs for the two regulation proposals, nor do we know the new Commissioners and how the medical devices dossier will sit in the Commission’s organization. So it’s too early to tell whether these two factors make a difference and what that might be.
My feeling is that these dossiers will drag on for a long time still, and this is not in the interest of the EU, which badly needs an updated regulatory framework to deal with modern technology such as nanotech and 3D printing. The FDA seems very active in modernizing its approach and planning ahead with a new four year plan. All the EU has brought to bear so far after the Commission’s initial proposal for the new regulations are disharmony, delays, insecurity and fact-free proposals that do not solve the problems. Not a pretty picture of an effort that is supposed to set the goal posts for EU medical devices regulation for decades to come.
On a positive note, the current framework is and remain incredibly flexible and can still accommodate most regulatory needs even though it is in need of updating in light of the Goods Package (see here about the Blue Guide that explains it all). The Joint Immediate Action Plan forced the Member States to finally use the full extent of the current directives and take coordination seriously. If the regulations are slow to pass, count on more and prolonged activity under the Joint Action Plan or an Action Plan 2.0, because one way or the other EU medical devices law must advance, especially and foremost in the areas in scope of the Joint Action Plan and the Goods Package.