Don't lose the 3

Towards meaningful change

UPDATE: In a plenary session on 22 October, Members of European Parliament voted against the introduction of a US-style centralised pre-marketing authorisation system for medical devices in Europe. This vote paves the way for further discussion with EU Member States which, together with the Parliament must agree on a final regulatory framework for medical devices.

Today in Europe people have access to life-saving medical devices 3 to 5 years sooner than other parts of the world. The reason for this is Europe’s unique approval system, which has proven to be as safe as other systems in the world and is saving and enhancing many lives every day.

Many groups and experts in Europe, including doctors, patients and industry, agree that the current European system needs to be improved to cope with new medical technologies and innovations. But let’s keep what works and fix what needs to be improved instead of radically changing the system.

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Back to overview
  • European Parliament improves committee report; says no to centralised US-style system

    28/10/13 -

    In a plenary vote on 22 October in Strasbourg to decide the future of medical device regulation in Europe, the European Parliament “stopped short of a U.S.-style pre-marketing approval system” Reuters reported. The vote comes more than a year after the European Commission submitted its initial proposal for the revision of the EU Medical Devices Directives (MDD) in late September 2012. Members of the European Parliament’s ENVI Committee then voted on their final report on 25 September


    “Members of European Parliament (MEPs) have voted for much-needed measures to improve Europe’s notified body system, increase the transparency and traceability of medical devices, introduce unannounced site visits and provide for better stakeholder involvement” according to a press release from Eucomed, the European medical technology industry association. “This vote paves the way for further discussion with the Council.”

    The Parliament will now enter the negotiation phase with Council (comprised of representatives from the 28 EU Member States), which carries equal weight in the MDD decision-making process. The Parliament and Council must reach a compromise to agree on the joint final text of the MDD.

    Read the full Reuters article here.

  • Former ENVI MEP John Bowis says current MDD compromise threatens patient safety

    07/10/13 -

    Despite intentions to improve Europe's medical device regulatory system to better serve patients, "the ultimate outcome [of the current compromise adopted by the ENVI Committee] may not be greater safety, but less." says John Bowis, former MEP and ENVI Committee Member. "Reducing rapid access to medical technologies, while increasing costs to research and development for new technologies, ultimately harms patients rather than protect them."

    In an editorial in Parliament Magazine, Mr Bowis asks policymakers to consider fundamental questions on the cost implications of the proposal for patients, insurers, and health systems and urges them to undertake an impact assessment before moving forward with what he calls "a drastic shift from the Commission's proposal."

    "As a former policymaker and a very current patient, I believe these are crucial questions that need to be addressed and answered before any legislation is adopted. This proposal will fundamentally shape the provision of healthcare for the next 20 years and we must ensure that we get it

    right for patients. We really need an impact assessment so that decisions about the future safety and health of EU citizens can be fully understood before moving forward."

    Mr Bowis, who as an MEP served as a chief architect of the EU's cross-border healthcare directive, expressed confidence in his former institution: "I have no doubt that a balanced compromise can be achieved that takes account of safety without sacrificing accessibility for patients. A regulatory framework for medical technology in Europe that supports what we want, and need, as citizens and users of our health systems, is possible."

    Mr Bowis serves as Honorary President of Health First Europe, non-profit, non-commercial alliance of patients, healthcare workers, academics and healthcare experts and the medical technology industry. His editorial reflects a February statement from the organisation's members in which they called on EU policymakers to take a balanced approach for patients when revising the EU medical devices directives: "We outlined the need for safety and transparency for medical technologies, while also acknowledging that both safety and transparency could be achieved without compromising access for patients."

    Read the full editorial in Parliament Magazine here.

    Read Health First Europe's statement of the MDD here.



  • Current European Parliament proposal will kill device innovation on a global scale, commentator says

    02/10/13 -

    The system just voted by the European Parliament’s Environment (ENVI) Committee represents a more serious threat to medical device innovation than the controversial medical device tax currently being debated in the United States, according to an editorial in Medlatest.

    The world's medical device makers, small and large alike, rely on Europe’s efficient decentralised approval system to launch their products in a timely manner and prove to investors that their products serves patients well and are financially viable.

    Indeed, many medical devices are launched in Europe first only to be adopted much later in other parts of the world. But if that

    first step of European approval is significantly delayed, the domino effect on global access to new life-enhancing and life-saving devices will be extraordinary. “Medical technology and innovation therein, needs EU market access to be quick and pragmatic.” Writes the commentator.

    “When it comes to new concepts like transcatheter heart valves,” Medlatest writes, “Europeans are enjoying third generation devices with all their improvements, while their counterparts in the US are only just seeing first generation devices crawling into the market.”

    The writer pleads with policymakers to find a workable compromise, saying that “As a patient, I’d vote for a few pragmatic changes to make me feel comfortable devices used on me have been scrutinised by suitably qualified people with a burden of reasonable evidence required and clinical data transparency. Yes, there’s progressive stuff going on, but the overriding sense is that Eurocrats have the opportunity to chuck the kitchen sink at something that will win votes.”

    Read the Medlatest editorial here.


  • Small device makers and patients dealt devastating blow by European Parliament

    26/09/13 -

    Wednesday's vote in the European Parliament’s ENVI committee vote went “far beyond the Commission's original proposals, calling for the establishment of a new pre-marketing authorisation system for high-risk devices under the control of the European Medicines Agency (EMA)”, Reuters wrote in a piece published yesterday.

    Reuters quotes trade body Eucomed which feels that “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. “

    Eucomed also questions the capacity of the EMA to evaluate the 400 to 600 so-called "Class III", or high-risk, devices that currently available to European patients each year in Europe.

    In a related piece, the Irish Times highlights worries that its 25,000-strong medical devices industry will take a hit if the proposed system becomes a reality.  

    According to the article “industry players fear that the new regulation, which introduces a number of pre-market authorisation rules and the establishment of a new centralised European authorisation agency, could significantly reduce the speed at which medical products get to market.” A development that would in turn, reduce the speed new products are available to Europe’s patients.

    Read the full Reuters article here and click here for more from the Irish Times.


  • Parliament’s proposal to slow patient access in EU and US, writes Bloomberg

    25/09/13 -

    Adopting a centralized pre-marketing authorization system for medical devices like the one proposed by European Parliament Rapporteur Dagmar Roth-Behrendt will slow the flow of new technology to European and American patients, according to an article published by Bloomberg today.

    Small device makers depend on Europe’s regulatory system to launch new technologies in Europe first as the US FDA system for regulating devices is known to cause significant delay and additional cost.

    “If the rest of the world

    begins to raise the bar of approval to the U.S. level, it will surely damage investment in innovation and patient progress will plateau.” says Kevin Sidow of US device maker Moximed, whose knee implant is expected to gain US approval a full seven years after being approved for use for European patients.

    Medical device trade body Eucomed estimates that switching to a centralized system would cost small to mid-sized manufacturers an additional 17.5 million euros ($23.6 million) to get a device approved over a five-year period, based on a survey of its members.

    This added financial burden will deal a devasting blow to medtech manufacturers in the EU and US, which will slow the research and development  cycle that keeps new technologies coming to patients on both sides of the Atlantic. 

    Read the Bloomberg article here.

  • US doctors “envious” of European regulatory system, writes Euractiv

    15/07/13 -

    European doctors have joined US cardiologists in expressing concern about calls for a centralised pre-market authorisation system for medical devices – a system shown in independent research to delay patients access to safe life-saving medical devices by 3-5 years.

    In an article by Euractiv, Dr Patrick O’Cara, a cardiologist with Brigham and Women’s Hospital in Boston pointed to  “frustration among … US care providers around delayed access to certain interventions that appear to be a winner.”

    Dr Angelo Auricchio, who is a member of the European Society of Cardiology and president of the European Heart Rhythm Association echoed the concern of his US counterpart, telling Euractiv that moving to a centralised pre-market authorisation procedure under a large agency like

    the European Medicines Agency is not what he would like to see. “You have everything going there from devices to pharmaceutical components. This is not the right thing to do. You may not want to use the words ‘it’s a US-like system’, but it is a US-like system,”

    Auricchio said that instead of a centralised pre-market authorisation system, Europe should improve the synchronisation of the different national regulators. “The problem is that we know very well that some competent authorities in Europe are extremely good and I would say even better than the American competent authorities. So it’s a matter of better coordination of knowledge among the competent authorities,” the doctor said.

    He added that the FDA system in the US would have been unable to prevent the scandals recently seen in Europe. “It’s actually nonsense to have a pre-market approval as the FDA has. Patients in the US often wait 4-5 years longer for great therapies that we have in Europe. We have a great advantage. These advantages have to come with the knowledge of potential risk, but what you want to do is to limit the risk and to accurately monitor the effect of the therapy,” Auricchio told Euractiv.

    Read Euractiv's article here.

  • Investment flow to small producers of essential devices at risk, Reuters writes

    27/06/13 -

    Moving to a centralised pre-market authorisation system could be devastating for European patients and the thousands of small European companies who produce medical devices, according to an article published yesterday by Reuters.

    "An FDA-like system would kill patients and kill innovative companies," says Antoine Papiernik in the article, who serves as managing director of venture capital (VC) firm Sofinnova. "It would very likely kill VCs as well, who already have a hard time explaining to limited partners around the world that they should invest in Europe."

    Eucomed Chairman Dr. Guy Lebeau points out that a centralised

    PMA system would not have prevented a case of fraud like the PIP breast implant scandal.  Instead, Europe would simply suffer a 3-5 year delay in getting devices to market which would ultimately harm patients.

    The article details Europe’s role as a hotbed of medical device start-up activity highlighting that “Since 2007, venture firms have invested in more than 1,500 small and medium-sized medical device companies in Europe, creating medtech hot-spots in Britain, Germany, France and the Nordic countries. Inventions from these start-ups have often gone on to be acquired by global companies, fuelling innovation in areas from hip implants to keyhole surgery to heart medicine”

    Sofinnova’s Papiernik points to Europe’s predictable regulatory environment (with its efficient decentralised approval system) as a driver of the investment flow towards safe, life-saving medical devices desperately needed by European patients. But this comparative advantage “would be lost if the new rules went through and investment would be slashed.”

    Read the full article on Reuters here.


  • Reuters publishes list of cardiovascular devices delayed in US

    14/06/13 -

    Following its coverage of frustration among US cardiologists with delays in access to essential cardiovascular medical devices caused by the US FDA’s pre-market authorisation system, Reuters has published

    a list of the devices in question.

    The 9 devices listed have either been available to European patients significantly earlier than in the US or are still pending FDA approval.

    The list includes technologies like renal denervation which benefits patients whose treatment-resistant hypertension cannot be addressed by drugs alone. European patients have had access to the procedure and the device needed to perform it since 2010. As of today, an estimated 7 million patients in the US with treatment-resistant hypertension are still waiting.

    Click here to see the entire list on Reuters.

  • US heart docs lament delay of device available in Europe first

    04/06/13 -

    According to an article in Reuters last week, frustration among American cardiologists is on the rise as they face significant delays in access to the latest devices required for Transaortic Valve Replacement (or TAVI, as it is known in Europe).  Doctors fault the US FDA’s centralised system for approving the devices for causing the delay.

    TAVI is a less invasive procedure used to treat patients with a faulty aortic valve for whom traditional surgery may be too risky. TAVI was approved in Europe in 2007. In the US,

    which has a centralised system for regulating medical devices, patients had to wait until 2011 to receive this life-saving device.

    "With this disease, if you wait two or three years, 60 or 80 percent of (patients) are dead. So not to have the most updated version of the device to treat more patients like this doesn't seem to be a particularly good idea," said Dr. Martin Leon, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York.

    EU approval of the third generation of TAVI is expected by end 2013 while US patients and doctors still only have access to the first generation of the device. "As you get physician experience developing, you also start immediately improving the product," Eucomed CEO Serge Bernasconi explains in the article. "That explains why by the time it gets to market in the U.S., often in Europe we are already on the second or third generation."

    Read the full article in Reuters here.

  • US doctors frustrated by centralised system delays

    27/05/13 -

    American cardiologists are frustrated by lengthy approval delays of essential cardiovascular medical devices caused by the US FDA’s centralised approval system, according to a Reuters article published on 27 May.

    The article points out that “From 2006 to 2011, European regulators approved mid-to-high-risk medical devices, including heart devices, an average of four years ahead of the more conservative U.S. Food and Drug Administration, according to a report last year by Boston Consulting Group. The

    quicker road to market in Europe did not lead to a discernible increase in recalls or safety problems, according to BCG and the California Healthcare Institute, which conducted the study, and Eucomed, the European trade group.”

    Dr. Patrick O'Gara, a cardiologist with Brigham and Women's Hospital in Boston said "There is frustration among the U.S. investigators (researchers) and U.S. care providers around delayed access to certain interventions that appear to be a winner."

    Doctors voice concern in the article about calls from some voices in Europe to move towards a US-like centralised system for regulation medical devices and away from Europe's current decentralised system. Mayo Clinic cardiologist David Holmes told Reuters  "I think we need to meet somewhere in between...Europe may need to tighten its regulations without necessarily adding years to its process."

    Click here to read the Reuters article in its entirety.

  • The reasoning behind the Don't lose the 3 campaign

    02/05/13 -

    My journey at the European industry association Eucomed started two and a half years ago. During my interviews for the communications role I was made aware that the medtech industry was facing new European legislation and that the process was underway. Never did I expect the need for a forceful modern communications campaign.

    I’ve been trained professionally by a global communications consultancy firm which teaches you to be an

    honest devil’s advocate when advising clients. So during the last couple of years at Eucomed I’ve been able to ask many critical questions about industry’s suggestions for the new regulatory framework. I truly believe it is fair to say that industry has never opposed change and is willing to make the adjustments and investments that are necessary to improve the current approval system, which is decentralised. In essence, the industry asks for a system that improves patient safety and doesn’t unnecessarily tamper with the flourishing innovative ecosystem in Europe that is dominated by small and medium-sized enterprises. Many of these companies are developing innovative medical technologies that not only improve the lives of patients but also contribute to making healthcare systems more efficient, which is desperately needed in these times of economic hardship. Read more...

  • Sickle cell disease patients fearful of potential delays

    23/04/13 -

    Dr. Asa'ah Nkohkwo, Technical Advisor for Sickle Cell Disease to the UK National Health System, is concerned that the move to a centralised approval system for medical devices could delay sickle cell patients' access to critical medical technologies. Dr. Nkohkwo, who has lost his own

    son to sickle cell disease ten years ago, is keen that users of lifesaving sickle cell technologies and policymakers understand the risks posed by the revised legislation.

    He also expresses concern that increased bureaucratic and regulatory hurdles that could be introduced by the legislation could drive investors away from the sickle cell sector. "We have fought for 20 to 30 years to get where we are now. The last thing we want is investors losing interest in our sector", says the sickle cell advocate in an interview at recent conference of the UK Sickle Cell Society in London.

    Learn more about sickle cell disease here and watch this space for more from European patients whose lives have been changed or even saved by innovative medical devices.


  • Don't lose the 3 in less than 3 minutes

    25/03/13 -

    With debates in the European Parliament approaching an Easter-break lull, the time is ripe to let your politician know what is at stake with the Medical Devices Directives debate. Use this 2-minute video

    to educate policymakers about Europe's regulatory system for medical devices - a system that allows European patients access to safe life-saving and life-enhancing medical devices 3 to 5 years sooner than other parts of the world without compromising safety.

    Tell them that yes, the system does need to be improved - but we need to make the right changes to keep our 3-year advantage alive. We need to weed out the bad apples, check the checkers and give patients the information they need. Above all, we need to ensure that we...Don't Lose the 3.

    Grab their attention with this quick video and send them to Don't Lose the 3 to get the whole story.


  • Heart doc talks about delays; calls drugs and devices "profoundly different"

    22/03/13 -

    In an interview filmed in October 2012, Dr. Angelo Auricchio cautions against the significant delays caused by centralised approval systems and highlights the benefits of the efficient European system for medical device approval--which has allowed him

    and cardio colleagues (and ultimately, patients) access to "novel, innovative breakthrough therapies" 3 to 5 years sooner than other parts of the world. Better coordinated surveillance in the post-market phase, however, says Dr Auricchio, is an absolute must.

    Dr. Auricchio, who is President of the European Heart Rhythm Association and member of the European Society of Cardiology, says that drugs and devices are "profoundly different" and makes clear that the European Medicines Agency is not the right body to regulate medical devices.

    Click here to read the European Society of Cardiology's position on the revision of the European Medical Devices Directives.

What's going on?

Europe is known worldwide as a leader in medical device innovation –we develop the best and most advanced life-enhancing and life-saving devices in the world.

On top of that, Europeans have access to the latest medical devices on average 3-5 years sooner than people in other parts of the world—this is our 3-year advantage.

Why do Europeans have faster access than others?

We owe our three-year advantage to the tens of thousands of European medical device innovators … and a decentralised approval system that efficiently reviews the safety and performance of new medical devices without causing unnecessary delay.

Research has also shown that the Europe’s system is just as safe as the centralised system used in other parts of the world such as the US.

But our 3-year advantage is at risk

Certain voices in Brussels are calling for radical changes to the system that would dramatically slow it down and unnecessary delay life-saving medical devices reaching patients.

They want to move to a slow, bureaucratic centralised system that has been proven to delay patient access to new medical devices by 3 to 5 years and without adding any additional safety for patients.

"We have fought for 20 to 30 years to get where we are now. The last thing we want is investors losing interest in our sector" #dontlosethe3 #eu_mdd

Dr. Asa'ah Nkohkwo, Technical Advisor for Sickle Cell Disease to the UK National Health System, is concerned that the move to a centralised approval system for medical devices could delay sickle cell patients' access to critical medical technologies.
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Why do 3 years matter?

  • Florence's story

    Florence is an actress, but her story is typical of the many Europeans struggling with treatment-resistant hypertension. Hypertension, or simply “high blood pressure”, can usually be treated by pharmaceuticals. But in many cases, drugs alone will not stop the problem from getting worse or having significant side effects—especially as patients get older. The only option that these patients have is receiving an innovative medical device procedure called renal denervation.

    The renal denervation procedure removes overactive nerves deep in the kidney that fuel rising blood pressure. Within 6 months of receiving the procedure, patients’ blood pressure begins to drop and often returns to a manageable level and saves the patient.

    European patients have had access to the procedure and the device needed to perform it since 2010. As of today, an estimated 7 million patients in the US with treatment-resistant hypertension are still waiting.

    Hear from real patients whose lives have been changed by medical devices.

  • Hans's story

    Hans is an actor, but his story is representative of thousands of patients across Europe with a faulty heart (aortic) valve. For the sickest patients who cannot undergo surgery, the only way to survive is by having a Transcatheter Aortic Valve Implantation (TAVI). This is an innovative way to implant an artificial aortic valve inside a patient without having to undergo open heart surgery (surgical aortic valve replacement).

    Transcatheter Aortic Valves were approved in Europe in 2007. In the US, which has a centralised system for regulating medical devices, patients had to wait until 2011 to receive this life-saving device.

    Hear from real patients whose lives have been changed by medical devices.

  • Michael's story

    Michael is an actor, but his story is one shared by the many young sickle cell disease patients in Europe – patients who inherited abnormally shaped red blood cells, that tend to block their small blood vessels. Almost all sickle cell patients experience painful episodes or ‘crises’, which can last from hours to days.

    Many sickle cell patients receive regular blood transfusions from donors with healthy red blood cells. Blood collected from those donors can be processed using machines that filter out certain substances to make the blood suitable and safe for transfusion. For a sickle cell patient, high quality blood means a high quality of life. One life-changing blood processing machine proven to provide patients with high quality blood was approved for use in Europe in 2008. In the US, patients are still waiting for approval - years that feel like a lifetime to young patients.

    Hear from real patients whose lives have been changed by medical devices.

Don't lose the 3 advantages of the european system

The European approval system needs to be improved, but let’s make sure we don’t lose the three advantages when we make changes to the system.

  • 1

    Let’s make the system even safer.

    Europe’s system has proven to be among the best in the world. Let’s make sure safety continues to be a top priority by keeping what works and fixing what needs to be improved.

  • 2

    Let’s keep the system fast.

    Europeans have access to the latest life-enhancing technology on average 3-5 years sooner (!) than people in countries with a centralized system for medical device approval. Let’s make sure Europe keeps its decentralised system that serves patients the best.

  • 3

    Let’s keep medical device innovation in Europe.

    Europe is known as a world leader in medical device innovation. Let’s make sure doctors, patients, academics and companies continue to work closely together to keep Europe ahead in bringing medical devices that can improve and save lives.

Don't lose the 3 solutions that will improve the european system

Some voices in Brussels are calling for radical changes of the European system that will cause us to lose our advantages. What we need are effective changes that will improve the system but still keep our advantages alive.

  • 1

    Get rid of the bad apples!

    The PIP breast implant incident was a case of fraud - plain and simple. We need to improve our system to make sure wrong-doers are identified quickly. For example, we need to make sure that the plants of manufacturers get checked more often including unannounced inspections.

  • 2

    Check the checkers!

    We need to make sure that the organisations responsible for checking the devices before they reach patients (Notified Bodies) are the best in the business. They should be experts in the devices they check and be transparent about who works for them and the data they produce.

    Notified Bodies should be subject to very strict requirements and frequent inspections by authorities to make sure that they are independent scientific centres of excellence and that only the best ones make the cut.

  • 3

    Give patients the information they need!

    Patients have a right to information about the medical devices they use and medical devices used on them. The system should use the data it gathers to provide more information to the public.

What can you do?

If you’re a Member of European Parliament

  • Read the research which shows that “rapid approval offers significant benefits to patients” and warns that “regulatory delays in centralised systems like the US are detrimental to patients”
  • Understand the potentially dangerous consequences for patients of choosing a centralised regulatory system for medical devices.
  • Don’t lose the 3 advantages of the European system and Don’t lose the 3 solutions that will improve the European system

If you’re a patient, consumer, doctor, or a concerned European

  • Tell your Member of European Parliament what you think
  • Spread the word on or
  • Pin on

I still have some questions

What exactly is a medical device? And why should I care?

Chances are you’ve had quite a bit of exposure to medical devices without even realising it. They range from simple sticking plasters and eyeglasses to pacemakers and prosthetic limbs.

Click here for a one-minute video that shows you what medical devices can mean to you, your family and your friends.

How do you know that the EU system is faster? And that a centralised system is slower?

Independent research has confirmed that the EU’s decentralised system provides patients with access to the latest life-changing medical devices 3 to 5 years sooner than the centralised system (the FDA) used in the US.

Researchers have also concluded that “rapid approval offers significant benefits to patients” and warns that “regulatory delays in centralised systems like the US are detrimental patients”

Click here to read the report.

But isn’t a centralised system like the US system safer for patients?

No. Research has shown that the two systems are equally safe.

Researchers assessed comparable products recalls between the US and Europe and concluded that earlier approvals in Europe do not compromise safety for patients.

Click here to read the research report.

Pharmaceuticals are regulated partly by a centralised body in Europe. Can’t we just copy that system for medical devices?

The system for pharmaceuticals would not work for medical devices. Doctors have pointed out that pharmaceuticals and medical devices are extremely different for many reasons and should not be regulated by the same system.

Click here to hear what doctors and patients think.

Should the European Medicines Agency (EMA) regulate medical devices?

No. Research shows that a centralised body like the EMA will cause unnecessary delays and add no additional safety for patients.

For example, the US system is centralised and they have been trying for many years to speed up the process but are still 3-5 years slower than in Europe.

Read the research here

Don’t we need a centralised system stop a case like the PIP breast implant scandal from happening again?

No. The PIP breast implant incident was a case of fraud. The manufacturer secretly replaced medical grade silicone with industrial grade silicone to save money. No regulatory system, centralised or decentralised, can fully guard against fraud.

Manufacturers should be subject to unannounced inspections to make sure their products are exactly what they claim to be. We need to get rid of the bad apples to keep patients safe.

Who is responsible for this campaign?

The European medical technology industry association Eucomed has created and sponsored this campaign. Industry believes that the current European approval system needs to be improved through effective measures that improve patient safety. For more information about what the industry thinks that needs to be changed, please click here.

More questions? Contact us