Further steps in Medical Devices Regulations in EU - Comments?

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gereard_kgb

#1
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Marc

Hunkered Down for the Duration with a Mask on...
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#2
In case the links go dead in the future:

Health MEPs call for stricter controls on medical devices
Committees Committee on the Environment, Public Health and Food Safety [25-09-2013 - 19:02]

Stricter monitoring, stronger certification bodies, better traceability: following several recent scandals like the PIP breast implant and the hip "metal on metal", health MEPs amended draft legislation in order to better protect patients on Wednesday. They also introduced stricter rules on informed consent and ethics in a separate law on in vitro diagnostic medical devices, used for example for HIV and DNA testing.

The legislative proposals aim to iron out inconsistencies in the interpretation of current rules, boost public health protection, remove obstacles faced by industry in the EU internal market, improve transparency of information to patients and strengthen traceability rules.

"We have achieved our main objective: patients will be better protected from defective products. We were able to enforce our goals and to be more ambitious than the Commission proposal. We really needed to put patient safety first and to bring transparency to an industry that is quite unregulated", said rapporteur Dagmar Roth-Behrendt (S&D, DE). ?We now hope that the improvements we have achieved will not be diluted later in the legislative process?, she added.

Tougher controls

The committee?s amendments would boost public access to clinical data, create a new approach to labelling medical devices, and create a new advisory body of experts. Beefed-up conformity assessment bodies (called ?notified bodies?) will provide closer scrutiny of manufacturers? own product safety tests. The bodies must have a permanent team of in house experts who meet new requirements for minimum qualification requirements.

MEPs propose that special notified bodies are designated by the European Medicines Agency in order to assess a select number of devices that pose the highest risk. For certain high risk devices, a special case-by-case check will be conducted by a proposed new expert body - the Assessment Committee for Medical Devices.

In vitro diagnostic medical devices

In separate legislation aiming at reinforcing patient safety for in vitro diagnostic medical devices (such as for diabetes, HIV and DNA), the committee called for involvement of an ethics committee and introduced provisions on informed consent and genetic counselling.

"Europe has a duty to make sure that advice for genetic tests is provided. Unfortunately, not all EU countries rules currently protect patients. It is very important that DNA tests are carried out in a protected area, by trained staff, and that appropriate consultation takes place", said Peter Liese (EPP, DE), the MEP responsible for steering the legislation through parliament.

MEPs also set new conditions for the involvement of minors and incapacitated people in clinical studies and proposed new criteria regarding access to data collected in such studies.

Next steps

Both draft laws are due to be put to a vote by the full House during the 21 to 24 October session in Strasbourg.

Directorate for the Media
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Reference No:20130923IPR20607
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EN

and...

Eucomed said:
Rushed deal leaves patients and jobs in second place

EUROPEAN PARLIAMENT COMMITTEE FOR HEALTH AGREES ON A RUSHED DEAL ON MEDICAL DEVICES LEGISLATION

Political groups contradict their election campaign promises to support European innovation and boost jobs as they create a heavy bureaucratic system that lacks the proof in delivering additional safety, brings unnecessarily delays in lifesaving medical devices reaching patients and strangles Europe?s innovative medical technology SME ecosystem.

Brussels, 25 September 2013 - Eucomed, the European medical technology industry association, expresses disappointment and strong concern at the outcome of a vote in the European Parliament?s Committee for Environment, Public Health and Food Safety (ENVI). The Committee has voted in favour of an extreme heavy bureaucratic procedure which combines a complex, unpredictable scrutiny process with a de facto case-by-case centralised pre-marketing authorization system. The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe?s 25,000 small and medium-sized device makers. The ENVI committee compromises patients and jobs in a what looks like a rushed through deal that seeks to satisfy the time pressure that Parliament feels ahead of the European elections, but not the needs of Europe?s patients and doctors. For several political groups, the outcome also represents a drastic shift away from their pro-innovation, pro-competitiveness platforms on which they are campaigning for re-election in 2014. It is now up to the political groups in light of the plenary vote in October to turn the ?rushed deal? into a ?right deal? for patients and jobs.

The agreement adopted today has the characteristics of a deal cobbled together as it combines many elements of the Commission?s and Rapporteur?s proposal. The ENVI Committee has voted for a scrutiny procedure that is much more complex than the one proposed by the European Commission in article 44, and introduces an extreme bureaucratic case-by-case centralised pre-market authorisation system, as proposed by the Rapporteur, that is managed by 21 groups of clinical experts as well as the European Commission and the European Medicines Agency. Far from the initial committee of 28 experts foreseen by the European Commission with a very focused mandate, the new committee is almost Kafkaesque in its construction with over 600 medical experts chosen from across Europe deciding across 21 sub-committees. No assessment has been made of any kind as to what real safety gains there would be, what delays it would cause for lifesaving devices reaching patients and what the exact cost of the added bureaucracy to European governments and industry will be. Industry has calculated that the proposed system will result in a bureaucratic behemoth costing anywhere between 10 and 25 billion Euros and that in no way achieves the shared objective of improving patient safety. Instead, the proposal represents an exercise in deal making that capitalized on MEPs? collective desire to conclude a time-consuming, very technical dossier before campaign season.

In addition, special notified bodies will be designated and managed by the European Medicines Agency (EMA), while not answering the question what qualifies an agency with limited medical device expertise to do this job. Taxpayers will de facto pay twice for the same procedure: once to equip special notified bodies with qualified experts (which is in itself the right approach) and again for the new conglomerate of up to 600 clinical experts who do a second assessment of the product, which is an unnecessary duplication and an inconsistency in the proposed system. If the proposal is carried in the next plenary vote in the European Parliament it will throw a blanket over European MedTech SMEs, innovation and inbound investment.

Eucomed CEO Serge Bernasconi: ?This compromise proposal on the table is said to be dramatically different than the heavy centralised pre-market authorisation system as proposed in the draft ENVI report. Let it be clear that this is a PMA in disguise carried out on a case-by-case basis and will deal a blow to patient access and medical device innovation in Europe. Also, no-one has shown how any part of the proposed new PMA system would have changed the outcome of PIP or any other safety issue. Bureaucracy will not prevent an alleged fraud like PIP. Concrete actions do. The measures that the Commission adopted yesterday do clearly help prevent incidents such as the PIP happening again as they include unannounced visits of manufacturers and are fully supported by industry. Our industry is also committed to invest 7.5 billion Euro in effective and necessary safety measures. But making us spend more than our total R&D budget for a system without any proven benefits for patients is beyond my comprehension. The political groups in the parliament still have time to assess the impact of the system on patients, innovation and resource implications and fix this rushed deal into a right deal when the vote enters the plenary session in October.?

The ENVI committee also showed another seemingly blind spot to reality and the needs of patients. Despite a growing European consensus against the re-processing of single-use medical devices including a full ban in France, the ENVI committee has voted in support of a measure that would make all devices re-processable by default. Eucomed believes the measure threatens patient safety by failing to require re-processors to meet the same safety and regulatory standards of original manufacturers.

Industry strongly believes that a move towards a system as proposed by the ENVI Committee is not the right way forward for the well-being of patients and the future of medical device innovation in Europe. Multiple scientific reports and studies clearly indicate that a centralised pre-market authorization (PMA) system for medical devices, similar to the one used by the FDA in the US, will deliver no additional safety benefits for patients and will cause unnecessary delays of 3 to 5 years in lifesaving medical devices reaching patients. A case in point is the example of an innovative medical technology like renal denervation for the treatment of severe, uncontrolled hypertension in patients whose condition cannot be treated solely by pharmaceuticals. This technology is already saving the lives of patients in Europe while an estimated 7 million Americans with the condition are still waiting for this procedure to be approved. Also US doctors have been extremely vocal about their frustration with such a system as it denies them and their patients access to the best available medical technology that saves lives. Leading European investors have also cautioned that an ?FDA-like system would kill patients and kill innovative companies.?

A survey of medical technology companies to assess the financial impact from 2015 to 2020 indicated that it will cost a SME an additional ? 17.5 million annually to bring a new Class III device to patients under the centralised premarket authorisation system as proposed by the Rapporteur. The European Commission?s original scrutiny procedure (article 44), the survey found, would cost an SME an additional ? 2.5 million annually.

Medical device manufacturers recognise that the current system needs an overhaul and acknowledge that change is necessary to improve Europe?s medical device regulatory framework. Industry has provided clear suggestions for necessary and effective improvements to strengthen the system. Especially with regards to the approval process and Notified Bodies, professional organisations that are authorised by national governments to assess the safety of medical devices before allowing them to be made available to patients, industry has suggested to:

Determine the appropriate competence that Notified Bodies must have in place to properly assess clinical evidence;
Determine strict and harmonised measures that Competent Authorities must apply for the designation, monitoring and control of Notified Bodies.

Contrary to the Commission?s scrutiny procedure (article 44) and the Rapporteur?s centralised approval process, implementing both propositions would lead to an EU-wide consistent, high quality approval system that does not unnecessary delay lifesaving treatments reaching patients and does not lead to an enormous bureaucratic burden.
 

pkost

Trusted Information Resource
#3
For those of you that like to read from source and not get the biased opinion of a press release:

the original commission proposal can be found here:
http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf

The amendments proposed by the lead parliamentary committee (ENVI) can be found here:
http://www.europarl.europa.eu/meetdocs/2009_2014/documents/envi/dv/936/936997/936997en.pdf

I've expressed by thoughts in a previous thread, about the original proposal. The amendments are causing further concern.

Their proposals fundamentally change the EU system, creating a hashed compromise that takes the worst of both worlds.

I have absolultely no idea how the changes are going to be resourced.

From a personal perspective, roll on the changes....Every medical device regulatory expert is going to be able to write their own pay cheque
 

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MIREGMGR

#4
I think US FDA's system works adequately well. Certainly it conservatively requires evidence that patients will not be acutely harmed, and obviously this often results in delays-to-market and resulting delayed profits for manufacturers. I think that's a reasonable balance.

I've never been convinced by arguments that device makers will give full consideration to patient safety in the absence of intensive pre-market review, or that time consuming pre-market reviews of new technologies and device types cause more patient harm than they prevent patient harm. Those arguments to me have always amounted to a smokescreen to obscure the true argument, that rapid and maximized manufacturer profits are more important than consideration of patient safety.

It seems to me that the EU authorities have been convinced that EU should harmonize somewhat toward the successful (in my view) US FDA approach, in this one (albeit important) instance. I think that's a well-founded approach.
 
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M

MIREGMGR

#5
For those interested in regulatory context, note that the USA organization most closely similar to EUCOMED is ADVAMED.

ADVAMED has argued and lobbied for a more EU-like (i.e. substantially unregulated, if one is willing to work the angles) clearance process for new technologies and higher-risk devices for a number of years. Their arguments have been essentially indistinguishable from those offered by EUCOMED, i.e. that horrible nasty regulators are destroying jobs and local economies, are anti-entrepreneur, and are brutally killing patients by preventing access to wonderful new technologies and device designs offered by altruistic medical device makers, purely so that their own cushy bureaucratic jobs and taxpayer-funded fat paychecks will continue.

I assume now that their lobbying thrust will change.
 
#6
I don't believe that the proposals are there to try and make the EU approach more like the US FDA approach. Rather, they are the result of poor understanding of the regulatory environment by the various committees involved.

There have been 2 acknowledged high profile problems. i) PIP breast implants ii) metal-on-metal joint implants. Because of these there has been the call "we need more regulation, we need more regulation" without any real understanding of how that might work or if it would actually improve patient safety in any way.

I would highlight that the gross fraud that occurred in the case of PIP would not be prevented by these proposed changes.

And metal-on-metal implants are just as much a problem in the US as they are in the EU.

I find it very disappointing that such significant changes can be proposed with so little understanding of the implications. Most disappointing is that, in part, this is a result of misjudged campaigning by groups such as the BMJ (British Medical Journal).

As always Erik Vollebregt (an occasional Cove-ite) gives an excellent commentary on this on his blog here:

http://medicaldeviceslegal.com/

Personally, I had hoped that these changes would be "kicked into the long grass" for a few more years. Just long enough that I could retire to somewhere nice and quiet!
 
M

MIREGMGR

#7
But do you not think that the fundamental belief of the supporters of these changes is that a more-regulated system will be better because self-regulation / NB-oversight-with-loose-controls-on-NB-qualification does not uniformly work, and that those supporters often hold forth the US FDA approach as an example of "better because more regulated" ?

Certainly that seems to be the subtext to me.

I don't think I've seen anyone from the supporter side suggesting that an FDA-like approach in the EU would have prevented either PiP or metal-on-metal. I do think that the underlying thrust is energized by a more-regulation-is-better viewpoint, and a general perspective that the loosely-controlled-NBs-competing-for-customers approach is inherently faulty.
 

pkost

Trusted Information Resource
#8
With regards to EU conformity assessment approach, I think we can all agree that it has it's weaknesses, equally the US approach has it's weaknesses, I do not think that they can be held up as comparable or either said to be better than the other. This is because although they both have the same ultimate goal of ensuring that only safe and effective products reach the market they were created in different cultural, political and social environments.

Both systems can learn from the other, but this does not mean that it is appropriate to replicate one or the other.


Specifically with regards to the EU system, I believe that the flaw is that not all NB's are created equal; if I (as a maunfacturer) find an overly strict NB, I can move to another who is more amenable to my lax attitude to risk. This should be corrected by appropriate levels of oversight of the notified bodies to ensure that:

1. Notified Bodies are consistent in their approach
2. Their approach is of a sufficiently high standard to ensure the aims of the conformity assesement are met.

Similarly the competent authorities are unequal in their approach and this needs to be monitored to ensure consistency.


The amendments tabled by the ENVI committee perpetuate this discrpancy, even going so far as to say that there should be "special" notified bodies that are capable of assessing higher risk products.
 
M

MIREGMGR

#9
I'm under the impression that the change-proposal grew out of a practical-political determination that there was no politically viable way to achieve:

1. Notified Bodies are consistent in their approach
2. Their approach is of a sufficiently high standard to ensure the aims of the conformity assesement are met.

Similarly the competent authorities are unequal in their approach and this needs to be monitored to ensure consistency.
...other than by creating a new class of NBs with new rules.

Political realities are political realities. It's usually not helpful to argue that a political-realities-conforming solution is undesirable because it doesn't change the political realities, unless that argument can include a viable mustering of the social forces needed to change those political realities. In this instance, I've seen various comments to the effect that the political realities are obnoxious, but no practical suggestions as to how they could be changed in the real world.
 
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#10
Oversite of the Notified Bodies is, generally, recognised as being a weakness. But such oversite is a 'National' responsibility (not EU central) and some of the EU nation states do not adequately resource such oversite.

It is the 'scare' stories of PIP and M-o-M that have been pushed around by those advocating more regulation. And the argument that 'drugs have to go through blinded clinical studies so why don't devices'.

So these proposals come along, 'super notified bodies' 'expert medical device committees' all to examine 'high risk' or 'novel' technologies (all so far un-defined). Where these 'experts' are supposed to come from hasn't been explained either.
 
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