Aug 20, 2015

On 19 June 2015 the Council of Ministers of the European Union decided on its “general approach” for the new Regulations for medical devices and IVDs.

This general approach should not be confused with its position after the “First Reading” as that is a formal position that has not been taken yet. After the proposals for medical devices and IVDs by the European Commission and the amended proposal by the European Parliament, this is the third version of this proposal.

(All pertinent documents can be accessed through the European Commission website.)

Beyond the First Reading
Getting to the final version of the Regulation requires a complex process with several formal steps and some intense rounds of negotiations. To keep this article accessible, that formal process will not be addressed in depth. For now it is sufficient to understand that the document is still in the “First Reading” stage. Once there is a compromise text, it will go into the “Second Reading” stage, where amendments by the European Parliament are still possible. If the Second Reading does not lead to an accepted document, there will be a Third Reading that may require mediation between parties. The First Reading does not have a specific time frame, but the Second and Third Readings have tight schedules. This is why the Commission Proposal of September 2012 is still in that First Reading stage.

It is very important to understand that at this stage all three versions of these documents are considered to have the same status and value. They are all three proposals, and they will form the basis of negotiations between the European Commission, Parliament and Council. These negotiations are expected to result in a compromise version that will be entered into the next stage.

More negotiations ahead
To facilitate these negotiations the documents will be joined in a table with four columns, the first three for the proposals, and the fourth for the compromise text. Over the coming months there will be several rounds of negotiations between the European Commission, The Council and the European Parliament. These so-called “Trilogues” are expected to carry on into the first half of 2016. If this goes well, the parties will finally agree to a final version for the Second Reading. The Dutch Minister of Health has expressed the ambition to have this document (almost) ready by June 2016.

It is not anticipated a new full impact assessment will be made, although it is possible that for some new items this will be done on a small scale.

Although there is nothing decided, it is possible to predict with reasonable accuracy how the majority of the new requirements will look. Both the European Parliament and the Council have accepted most of the new proposal by the European Commission. But there may be some differences in the details. However, there are also a few more fundamental differences for which the final outcome is hard to predict.

Here is an example of how a section of the compromise text may look. Be aware, this example is a best guess and companies should not presume this to be the final Regulation.

It is almost certain the risk-based system with four risk classes for IVDs will be part of the final version. Parliament proposes to have Class C IVDs also covering embryos whereas the other two proposals don’t mention embryos. This will probably be accepted, as in the original Commission proposal foetuses were already covered.

But what will determine if an IVD is Class C? Will that be “disease staging” (Commission), “disease staging or prognosis” (Parliament) or “disease staging, if there is a risk that an erroneous result would lead to … a life-threatening situation…” (Council)? Although these three versions may not look much different, the devil is of course in the details.

For individual manufacturers this may mean the difference between developing a device or not because of costs for the procedure. This also illustrates the challenge for these negotiators. From a safety perspective, tightening procedures and placing most devices in higher risk classes may look interesting, but it may be counter productive if this means safe and competitive devices are kept off the European market.

The negotiators will undoubtedly look for the best balance regarding risk versus innovation and availability of devices. So it can be expected that the final version will included “disease staging or prognosis, if there is risk that an erroneous result would lead to a life-threatening situation,” because this truly reflects a risk-based approach. But of course, we will have to wait until the final result is published until we can be certain.

Ronald Boumans is Senior Global Regulatory Consultant at Emergo's office in The Netherlands.


  • Ronald Boumans