Where is the EU medical devices regulations revision? It’s complicated…

380px-EU_Consilium_Logo.svgMany people ask me these days “Hey Erik, what is the status of the revision? When will this thing finally complete?”.

Well, that’s an interesting question I often ask myself too. Of course I have my crystal ball and some bits of information from here and there but that still allows me to speculate only.

So I decided to request access to the latest documentation on the Council negotiations on the revision on the basis of EU freedom of information legislation. The Council had just published references to a bunch of documents that seemed to reflect the latest state of play.


I had already heard from sources close to the negotiations that they are pretty much stuck at the moment and the process is very slow going with many entrenched positions. Don’t forget, in 2014 the Council working group combed through each of the chapters of the medical devices regulation alone twice in about 20 meetings in total. That’s a lot of time and effort to not even get close to where you would like to be and achieve compromises that do not seem to happen.

All that seems to be completely confirmed by the rejection of my request for disclosure below. As you can see, even a rejection can provide a lot of information:

Schermafbeelding 2015-04-30 om 21.16.48

Schermafbeelding 2015-04-30 om 21.17.01

In other words, the process is so delicate at the moment that the member states do not want their positions in public. That leaves me with the impression that the process is currently like hedgehogs making love: very slow and very careful with a ‘great political will to make it work’ in the end.

The latest documents of the April meetings are not publicly accessible either. I could request those too but I already know the answer to that request I think.

I like the consolation though that the acts will be published when they are final – thank goodness for democracy and for deadpan bureaucratic statements.

So what are the member states stuck on?

Well, we had something of an idea by end of last year. In the presentations of the MHRA and BSI at the DIA Euromeeting in Paris beginning of April there was a good rundown of key outstanding issues:

  • ingested products – should they automatically be in the highest risk class (as currently proposed)?
  • ‘non-medical devices’ – what will be in Annex XV from the start; there may be a new category of so-called ‘common specifications’ (so non-technical common technical specifications) for these devices.
  • companion diagnostics – still disagreement about scope of the definition – align with FDA or not, cover selection and monitoring?
  • non-viable human tissues and cells – this will likely ‘be aligned with the ATMP regulation’, which itself is up for revision now.
  • viable biologic substances – exclusion where these support the intended purpose of the product
  • reprocessing of single use devices – member states like the Commission proposal (national prohibitions possible), but don’t agree about whether to make in-house reprocessing possible (I’m not going to those hospitals) and there is the European Parliament proposal to deal with (single use is like printing your own money, so everything is presumed reprocessible) to deal with. Remember, the trilogue still has to start and the Parliament will want to get something out of it too.
  • genetic testing – Council position to take to trilogues but there seems to be a majority that feels that the EU has no business in national practice of medicine. On the other hand, Peter Liese, the IVD Regulation rapporteur feels very strongly about this amendment regardless of how unconstitutional it is, which he sees as his baby.
  • implant card – provision of card vs provision of information
  • Eudamed & UDI – member states still disagree about what link Eudamed should have to UDI and how much detail should be left to implementing acts (over which they have little influence)
  • summary of safety and performance
  • notified bodies – supervision of notified bodies is still subject of disagreement, and should notified bodies do clinical audits?
  • pre-market approval – still one of the big ticket items, especially important to France: will we have scrutiny, scrutiny plus or a real EU devices agency like EMA?
  • clinical investigations – how do we align the clinical trials regime with the Clinical Trials Regulation with its different concepts? What clinical evidence is acceptable and how do we deal with equivalence?
  • post market surveillance – how prescriptive should the regime be and do we want regular (trend) reporting for high risk devices?
  • market surveillance & vigilance – how do we get to a coherent regime and how do we deal with risk vs incident?
  • reference laboratories – this is still being heavily debated: should there be a split between reference and testing labs? Do we even need reference labs (mainly an IVD item) for medical devices?
  • hazardous chemicals – big item for industry, member states divided over options of ban, phase out or labeling
  • classification rules – what devices get up classified (looks like implants, surgical instruments)?
  • governance and oversight – where do we get the money and the people to staff whatever it will turn out to be in the end?

This is a pretty long list of rather fundamental things to disagree about if you ask me. That is why I’m not super optimistic about a quick solution after the heroic crash and burn attempts of the Greek and Italian presidencies and the methodic current Latvian salami approach to the dossier, but hey, you never know. And it’s good to see that there is also at least some debate about the IVD Regulation. The MHRA speaker at the DIA Euromeeting compared the interplay between these issues to a game of Whack a Mole – when you think you’ve dealt with one, another pops up (again).

At least it seems there is no disagreement about the craziness of enormous scope extension of the definition of medical device proposed by the Parliament – I hope.


Time is of the essence by now – and this is the best time table we have for the moment (MHRA prediction from the DIA Euromeeting conference):

Schermafbeelding 2015-04-30 om 21.49.29

But will it blend?

But will it blend into compromises, these entrenched positions in the Council? And even then, what will the trilogue with the Commission and Parliament look like? You’ll remember that the Parliament deliberately took a completely different and far out approach on important points like hazardous substances, pre-market approval, notified bodies and genetic testing, just to mention a few. Difficult to see what the compromises on those points will look like, also because the rapporteur for the medical devices regulation dossier has changed in the mean time. I think I’ll have to boot up the crystal ball again for some more theorizing about where the institutional actors’ great political will to make it work will bring us – and when.

European Court of Justice introduces ‘product batch’ liability

logo-curiaThis blog has discussed product liability cases in relation to the EU Product Liability Directive before (for example here and here). Now there is another product liability case recently decided by the European Court of Justice, which can have big consequences for manufacturers of medical devices in the EU. This case is about pacemakers and ICDs specifically. A summary from the ECJ’s press release:

“A company which sold pacemakers and implantable cardioverter defibrillators in Germany found, after carrying out quality control checks, that those products might be defective and constitute a danger to patient health. In view of that situation, the producer recommended physicians to replace the pacemakers implanted in patients with other pacemakers provided free of charge. At the same time, the manufacturer recommended treating physicians to deactivate a switch in the defibrillators.

The insurers of the persons whose pacemaker or defibrillator has been replaced claim reimbursement of the costs relating to the replacement from the manufacturer. In proceedings between the insurers and the undertaking which markets those medical devices, the Bundesgerichtshof (Federal Court, Germany) has asked the Court of Justice whether devices that have been replaced in the case in point may be classified as defective, even though no defect has been specifically detected in those devices but the quality control checks carried out by the manufacturer on devices of the same model have disclosed a potential defect. The German court is also seeking to ascertain whether the cost of replacing those products constitutes damage for which the produce is liable under the directive.”

Let me start by saying that this case is special in the sense that the manufacturer himself recommended replacing the pacemakers of a specific type as a corrective action. The recommended corrective action for the ICDs was to deactivate a magnetic switch that might be stuck, as a result of which any cardiac dysrhythmia that could be fatal would not be recognised by the defibrillators and no life-saving shock would be given to the patient.

Not all product liability cases involve a specific corrective measure. The claim made by the healthcare insurer of the affected patients was based on product liability, which is harmonized in the EU under the Product Liability Directive. The manufacturer defended himself by arguing that although he had recommended replacing the pacemakers from a specific batch, this did not mean that they had admitted that all pacemakers in the batch were defective in the meaning of the Product Liability Directive, nor could it be assumed that every pacemaker in the recalled batch was defective just because they were in a batch that was recalled. The national court decided to refer this to the European Court of Justice for a final word on the aspects of EU law.

Product batch liability

The referring court found that the outcome of the disputes in the main proceedings depends on whether the pacemakers and the cardioverter defibrillators implanted in the insured persons concerned are defective products within the meaning of Article 6(1) of Directive 85/374. The referring court further found that it has not yet been determined whether, as those devices form part of a group of products that pose a risk of failure, they are themselves defective.

The ECJ solves this problem by introducing what seems to be a product batch liability by making the point that pacemakers and ICDs are special in that

“38 The safety which the public at large is entitled to expect, in accordance with that provision, must therefore be assessed by taking into account, inter alia, the intended purpose, the objective characteristics and properties of the product in question and the specific requirements of the group of users for whom the product is intended.

39 With regard to medical devices such as the pacemakers and implantable cardioverter defibrillators at issue in the main proceedings, it is clear that, in the light of their function and the particularly vulnerable situation of patients using such devices, the safety requirements for those devices which such patients are entitled to expect are particularly high.

40 Moreover, as observed, in essence, by the Advocate General at point 30 of his Opinion, the potential lack of safety which would give rise to liability on the part of the producer under Directive 85/374 stems, for products such as those at issue in the main proceedings, from the abnormal potential for damage which those products might cause to the person concerned.”

Because of this nature of the products and given the definition of ‘defective’ in article 6 (1) of the Directive (“A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account […]”), the ECJ decided to interpret the scope of the concept of defect in the Product Liability Directive broadly:

“41 Accordingly, where it is found that such products belonging to the same group or forming part of the same production series have a potential defect, it is possible to classify as defective all the products in that group or series, without there being any need to show that the product in question is defective.”

The result from this broad interpretation of the concept of ‘defective’ is that the scope of the concept has been expanded to include devices in the same batch that may or may not have the defect but are subject of a corrective action to mitigate the risk that they have the defect.

This extension of the concept of defective also changes the burden of proof of the person claiming damages under article 4, one of the cornerstones of the directive since the directive is based on a trade-off between one the one hand no fault liability for the manufacturer provided that the injured person proves damage, defect and a causal link between the damage and the defect. While the producer accepts no fault liability, the “injured person shall be required to prove the damage, the defect and the causal relationship between defect and damage” pursuant to article 4.

As a consequence of this judgment, this burden of proof rule does not automatically apply in case of product liability alleged for a device in a batch of potentially defect devices subject to a corrective measure of the manufacturer. Alternatively one could assume that the burden of proof is automatically met if the manufacturer initiates a corrective action for the devices concerned, but this is not discussed in the judgment.

What damages?

The product liability directive covers two types of damages: damage caused by death or by personal injuries or damage to, or destruction of, any item of property other than the defective product itself. The second question in the judgment  was if the costs associated with the recommended explantation constituted damage caused by personal injuries. Yes, says the ECJ, because if the manufacturer itself recommends replacement to mitigate a risk, then the explantation and replacement procedure constitute such damage:

“51 In the present case, as is apparent from the order for reference in Case C‑503/13, G. recommended to surgeons that they should consider replacing the pacemakers in question.

52 In that case, the Court finds that the costs relating to the replacement of such pacemakers, including the costs of the surgical operations, constitute damage within the meaning of section (a) of the first paragraph of Article 9 of Directive 85/374, for which the producer is liable in accordance with Article 1 of that directive.

53 That finding may be different in the case of implantable cardioverter defibrillators, as G. recommended, as is apparent from the order for reference in Case C‑504/13, that the magnetic switch of those medical devices should simply be deactivated.”

Does that mean that costs for replacement of implants that you can switch off to mitigate the risk of the potential defect does not constitute damage under the Product Liability Directive (like was the case for the ICDs concerned)? Strangely enough not automatically, because

“54 In that regard, it is for the national court to determine whether, having regard to the particularly vulnerable situation of patients using an implantable cardioverter defibrillator, the deactivation of the magnetic switch is sufficient for the purpose of overcoming the defect in that product, bearing in mind the abnormal risk of damage to which it subjects the patients concerned, or whether it is necessary to replace that product in order to overcome the defect.”

In other words, we do not know very much now because this is a very factual question that each national court may decide for itself in the context of the device concerned – unlimited permutations possible.

What about devices that do not need to explanted in order to mitigate the risk resulting from the potential defect?

This case concerned the costs of the medical procedure to replace the high risk implantable medical device subject to the recall. The ECJ seems to take the view that the patient should never have to pay for the costs to remove a device that is potentially defective by the manufacturer’s own judgment and exposes the patient to very high risk if it is not removed. So, what other devices could be covered here?

First, foremost and obviously, the liability would not seem to extend to implantable devices that can diagnosed from the outside, e.g. a pacemaker that was in the batch of potentially affected products, but which can be diagnosed and established not to have the defect.

Secondly, the device has to have a particular risk profile as a consequence of which patients are in a ‘particularly vulnerable situation’ and it must have an ‘abnormal potential for damage’. What this concept means is not explained in the judgment, so this will be subject of further clarification in the courts. I will explain below why this criterion is absolutely unhelpful for medical devices (or other regulated life sciences products for that matter).

What is ‘abnormal potential for damage’?

What devices are covered by this product batch liability? The reason for product batch liability comes after all, according to the ECJ, “from the abnormal potential for damage which those products might cause to the person concerned” (point 40 of the judgment – italics added). First, it  would seem to mean that there is no reason for such liability for devices that have a lower risk profile than those devices, let’s call that a ‘normal or lower’ potential for damage. Secondly, the use of the term “abnormal” potential for damages is very tricky in my opinion because it does not take account of the fact that with all potentially dangerous products the risk is always relative to the benefits. Indeed, this is the very basis for granting market access to such devices. Viewing risk in absolute terms does not lead to a meaningful outcome because in that case pacemakers and ICDs would never be admitted to the market as a result of their ‘abnormal’ potential for damage. The ECJ seems to forget that this ‘abnormal’ risk is cancelled out by their equally abnormal benefit (you don’t die on the spot when otherwise you would).

So as a consequence of the judgment of the ECJ we now have a known unknown category of devices with an abnormal potential for damage – but what type of devices fall in that category? Indulge me in a though experiment with some basic thinking about risk management and try to point out in the below very well known GHTF risk chart  for interpreting risk and communicating about risk where you would place an ‘abnormal potential for damage’. Top right corner only (most extreme risk)? Red only (high risk)? Maybe yellow in S-5 (remote probability but catastrophic harm)?

GHTF/SG3/N15R8 Example of a Risk Chart for Communicating Internal Risk Management Activities

GHTF/SG3/N15R8 Example of a Risk Chart for Communicating Internal Risk Management Activities

Or should we think in the regulatory risk classes I, IIa, IIb or III under the Medical Devices Directive? Or only devices in scope of the Active Implantable Medical Devices Directive? This problem is impossible to solve this way, because the ECJ used an absolute and undefined term to indicate a particular risk. As a result, we have an additional point of argument between patients and manufacturers: is the risk profile of a device ‘abnormal’ enough to warrant product batch liability?

In my opinion the ECJ has done nobody a favor with the term ‘abnormal potential for damage’ because it would seem to place certain (we don’t know which ones) high risk medical devices in a fictitious group of devices that should actually not be on the market or are ‘too dangerous’ or something and therefore a special type of product liability applies. This thinking is wrong and unhelpful, because it fails to take account of the fact that all medical devices admitted to the market have a risk profile that is the contrary of abnormal in their side effects and in their failure modes. Otherwise they could never ever pass the risk management requirements under the (active implantable) medical devices directive and should not be admitted to the market.

I understand that the ECJ tried to make sure that patients would not be forced to pay themselves for removal of an active implant that the manufacturer himself says should be replaced as corrective measure. However, in order to arrive at that conclusion it did not need to go into a discussion of risk in absolute terms that flies into the face of the regulatory acquis in the field of risk management. Rather, it could have found that since a defect could only be established and managed by explanting the device in the first place, the associated costs would be the risk of the manufacturer since he ordered the recall. More practical and less confusing if you ask me, because now we are stuck with having to decide if the device concerned has a risk profile that allows it to inflict abnormal damage.


The ECJ has done its best – it seems – to arrive at a solution that leads to the result that a patient should never be stuck with the medical costs associated with the replacement of a device that is subject to a manufacturer corrective action. However, its use of language about risk in absolute terms has made things a lot less clear than they were by limiting this to a category of products with ‘abnormal potential for damage’ distinguished from other products covered by the Product Liability Directive.

Netherlands compliance update

MedTechOn 13 January I presented the yearly complaince update for the Netherlands to the Medtech Europe Compliance Network in Brussels. Since the presentation is no secret know-how, I thought I’d share it on the blog, with an overview of the developments discussed in it.

Can’t ask what can’t be offered

2014 was the year in which most of the healthcare professionals (HCPs) in the Netherlands had to come to grips with the fact that their professional assocations had adhered to the GMH Code, thus solving the much lamented problem that HCPs were asking for benefits that the industry was not allowed to offer. Since 1 January 2014 HCPs cannot ask anymore what industry cannot offer. This closes an important gap that tends to undermine industry’s support of selfregulation.

The new version of the GMH code is here, and a track changes version of the code showing the changes for 2015 compared to 2014 is here.

2014 and 2015 are the years in which the Sunshine transparency requirements in the medical devices sector evolve and are implemented. If you read Dutch, you can read about it in detail in the Minister of Health’s update and the GMH’s plan for implementation, and if you don’t in slightly less detail in my below presentation:

Duty to report

A pilot project started as of 1 January that requires reporting of financial contributions by industry to costs of participation of HCPs in meetings. Any arrangements made have to be laid down in writing and must be reported to the HCP’s employer or board of healthcare institution.

Requirement of prior approval

As of 1 January all interactions that require payment of more than 500 Euro to an HCP for services rendered have to be set out and approved in writing by the HCP’s employer or board of the HCP’s healthcare institution.

External transparency

As of 1 january 2015 the GMH code started a pilot project of Sunshine transparency limited to certain implantables and certain HCPs, which requires that:

  1. manufacturers of ICDs, stents, pacemakers and hip-/knee replacements;
  2. have to track and report consultancy and sponsoring (of other activities than meetings, like education) interactions;
  3. with a total value per HCP of more than 500 Euro per year;
  4. with HCPs admitted in the Netherlands for the specialities of orthopedics and cardiology; and
  5. publish the interactions in the healthcare transparency register (Transparantieregister Zorg) as of 1 January 2016, before 31 January 2016.

Also, there is a prohibition to incorporate clauses in agreements that prevent publication of the relevant details in the transparency register. The GMH code offers model clauses to be incorporated in agreements that address the publication of personal data of the HCPs concerned.

Maximum HCP consultancy fees and costs

Then there is another requirement that you do not see back in the Minister of Health’s report about developments in transparency nor in the GMH plan of implementation: maximum fees and costs for consultancy by HCPs. This caused industry significant concern because this requirement for 2015 was added at the very last moment before adoption of the changes to enter into force on 1 January 2015 without much notice or possiblity to respond. The concerns mainly relate to the fact that the mandatory maximum rates are supposed be normal market value, which, is the common objection, they mostly are not. However, these were the rates that the code body for the pharmaceutical industry had already agreed with the Healthcare Inspectorate for the pharmaceutical field, so these were assumed transposable according to the explanatory notes to the new rates.

The maximum hourly rates are as follows:

  • professor – 200 Euro
  • medical specialist – 140 Euro
  • general practitioner – 100 Euro
  • pharmacist – 100 Euro
  • dentist – 85 Euro
  • nurse – 70 Euro

In case your marketing department thinks it’s clever and says that if the P goes down the Q can go up to achieve the same result, that may not work because the explanatory notes to the GMH code say that also the Q of hours paid should be reasonable given the “nature, qualifications and expertise of the HCP”. However, this qualification sounds more to me like a factor that would impact on the hourly rate than on the quantity of hours (at least in my own business of lawyering: the more experienced and specialised, the higher the hourly rate).

The maximum travel costs that can be reimbursed are

  • Car – 0,37 Euro per kilometer
  • Plane – no 1st class, only business class on intercontinental flights
  • Train – 1st class
  • Taxi – all, but ‘in addition to public transport’ (so no taxiing the whole distance between A and B if public transport is available?)

These costs come from the rules for Dutch civil servants. As tax payer to the Dutch state it is highly reassuring that apparently all Dutch civil servants can always fly business class on intercontinental flights. It’s allowed to compensate additionally for loss of income due to travel (unclear whether the maximum hourly rates apply, because the loss of income is often higher) but it’s not allowed to facilitate double dipping (pay for travel time and for preparation time if the travel time can be used for preparation).


Things are happening in compliance requirements in the Netherlands. Medical devices companies with implants concerned that have sponsoring and/or consultancy arrangements with Dutch HCPs in the fields of orthopedics and cardiology have to keep track of payments in 2015, and report during the first month of 2016. The Netherlands has thus joined a growing group of countries requiring sunshine transparency of HCP payments, albeit with a limited pilot.

Want more information? Just let me know.

More on 3D printing of medical devices – seminar in Amsterdam with DSM and Materialise

Because we see a huge increase in interest in regulation of 3D printing and biofabrication (which I have blogged and taught about), my firm decided to organise a seminar about it.

As you are used from us, it’s free, we don’t want anything in return, we love it if you show up and if you don’t that’s fine too – ask us for the slides if you would like to receive them (you can have mine in any event; you can have the others too if the other speakers agree to provide them). However, if you want the full story, it’s always best to attend because there will be drinks afterwards too at which you can network with other companies in the field.

We are very grateful for the cooperation of two companies at the forefront of developments in this field, Materialise and DSM Biomaterials, who will discuss case studies about their own products and services and provide insights into technical challenges.

To subscribe to the seminar, just send an email to the email address in the invitation below. You can bring as many colleagues, friends or contacts as you like; please just let us know in advance so we can have a name badge for everyone to improve your networking experience and ensure that there are enough chairs, drinks and snacks!

I hope to see you there.150204_3Dprinting_and_Biofabrication_edited-1

More on EU medical devices cybersecurity regulation

In a previous post I promised more on cybersecurity, so here it is.

Spoiler alert: the conclusion of this post is that cyber security requirements for medical devices in Europe are currently an overlapping patchwork of different statutes with little attention for system and network security. So the conclusion is: there is nothing specific, except the security requirements in the EN 62304 harmonized standard for Medical device software — Software life-cycle processes. Compared to what the FDA is currently working on the EU is seriously lagging behind, which is strange considering the ambitions that the EU has in eHealth, which will necessitate a lot of medical devices being networked into the Internet of Everything.

Personal data rules

That doesn’t mean that there are no general rules that manufacturers of medical devices must observe in the EU that touch upon cybersecurity. Currently there is quite an acquis being built up in terms of privacy by design obligations for networked devices that process personal data. This is the main approach to cybersecurity for medical devices in the EU at the moment.

Why the personal data nexus? Obviously, medical devices that form part of the internet of things (IoT) will process sensitive personal data in the form of personal health data. In addition to privacy by design requirements that I blogged about earlier, the Article 29 WP has now also issued guidelines for IoT devices that do focus on system security.

But, we are still not there because we are still waiting for the GDPR to drop, which will provide a framework for processing of personal health data that will apply throughout the EU. The Article 29 WP guidelines, as helpful as they are, remain non-binding guidelines.

NIS directive

The NIS directive is a new piece of legislation that will have particular relevance for companies that provide medical devices as a service or provide information society services that consist of monitoring, readout of devices at a distance, etc.

The Parliament has proposed to exclude software developers and hardware manufacturers from the scope of the directive. However, as I have observed many times now, medical devices manufacturers less and less mere widget pushers these days. As a consequence any medical device manufacturer that operates a service in relation to medical devices would be caught under the NIS directive. And the directive is not final yet, so things may still change.

Presentation to summarise

The whole above story is a summary of my below presentation at the MD Project Active Devices event on 9 December that raised some eyebrows in the audience and provoked comments that it’s impossible to meet all these requirements without considerable additional resources.

The extra long disco version of the material in the presentation can be found in my article in eHealth Law and Policy, which you can view for free if you take a free trial subscription.

The time to act is yesterday

Excuse me? Humbug you say? Medical devices is an industry in which hackers do not operate? All the succesful hacks that have happened so far took place only under controlled circumstances in unlikely usability scenarios?

I’ll speak with you again when your company does an e.g. Sony by being hacked painfully publicly several times in a single year and losing massive amounts of sensitive data (because that’s what hackers are after these days) or has the dubious honour of being the first company faced with ransomware holding active implantable devices of patients hostage.

Thinking that this will not happen to you is one of the oldest security fallacies in the book. Having been caught out ignoring this will not look good on a company, especially if you trust the company’s devices literally with your life.

And don’t forget, all the above does not only apply to the new devices yet to be placed on the market, but also to the vast amount that is already out there, with hardcoded admin passwords and less than stellar security measures built in. This means that – literally – the time to act is yesterday.

So Happy New Year – something should and hopefully will happen when we roll the dice in EU cybersecurity policy next year. Otherwise it may well become painfully obvious why we need specific and clear rules for this.

An X-traordinary New Year to you


The devices have landed – and some promotion

European CommissionSo, 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.

Impact assessment

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

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:

I hope to see you at one or more of these very worthwhile events!


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