Vista Optics is pleased to announce the launch of the unique Rigid Gas Permeable material BIO GP 100 with Biomimetic surface at 40th EFCLIN Congress and Exhibition on 9-11 May 2013. Dr Andrew Courtis, Technical Director of Vista Optics says: ” Bio GP 100 is the culmination of many years of multicenter and multidisciplinary research and development and has delivered an RGP material with unsurpassed comfort, wettability and deposit resistance.”
Brussels, 28 February 2013 – Eucomed, the European medical technology industry association, welcomes stakeholder calls at a public hearing of the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee on 26 February, for much needed improvements to Europe’s regulatory system for medical devices. Physicians, patient groups and industry made clear their desire for a system that improves patient safety, protects patient access to life-saving medical technology and increases transparency and device traceability. Various stakeholder groups noted that a centralised authorisation system for high risk devices would not lead to the desired increase of safety and bring unnecessary delays in patient access of medical technologies. Research shows that a centralised system does not increase safety and patients subject to such a system wait on average at least three years longer for receiving life-saving medical devices compared to patients in Europe.
Medical device manufacturers agree with the views of doctors, patients and some Members of European Parliament expressed at a hearing on 26 February that the current system must be significantly improved to increase patient safety, maintain timely patient access to the latest life-saving technology and keep medtech innovation in Europe. Panellists at the hearing proclaimed the need for greater transparency, traceability of devices and strict control of notified bodies—the entities charged with reviewing new medical devices.
A large part of the debate focused on how to organise the approval process of high risk devices. Industry expressed its view to significantly strengthen the decentralised device-specific approval system and not move towards a centralised pre-market authorisation system as seen in the US. Independent research concludes that patients subject to a centralised pre-market authorisation system, such as the US FDA system, wait 3 to 5 years longer for access to the latest life-saving medical devices. Research also clearly concludes that faster approvals in Europe do not compromise patient safety. Industry does support the idea that only a limited number of highly specialised Notified Bodies with proven clinical expertise should be eligible to approve Class III devices.
A concern was raised that European patients do not enjoy faster access than US counterparts because Europe’s national health systems are slow in reimbursing new technologies. While the approval of a medical device is for the whole of Europe, reimbursement is organised differently via national health systems. Early patient access in most European countries is ensured through special payment mechanisms and / or leveraging available reimbursement for innovative medical technologies. The existing special payment mechanisms accelerate access and bridge the period between product approval and new specific reimbursement for innovative technology. A recent study of the European Health Technology Institute (EHTI) conducted by the London School of Economics (LSE) reported that approximately 70% of countries surveyed use special payment mechanisms for innovative technologies and these are considered to be effective in integrating new technologies into the health system.
“We welcome the growing awareness of the benefits of the European device-specific approval system. We have made it very clear on various occasions that we want to significantly improve this decentralised system to guarantee the highest safety and avoid unnecessary delays of lifesaving medical technologies reaching patients. The European Commission’s proposal is a step in the right direction and we welcome many of the recommended measures. However, the proposed scrutiny mechanism is inappropriate because it does not contribute to patient safety and is essentially a duplication of reviews. We have suggested replacing the scrutiny mechanism with a systematic control procedure. We were surprised to hear doubts about the fact that European patients have faster access to safe medical technologies. We acknowledge that national health systems reimburse devices in different ways and at different speeds, but there is simply no doubt that these life-saving devices are available to European patients sooner than anywhere in the world. The fact remains that a technology like renal denervation is already saving the lives of European hypertension patients whose condition cannot be treated solely by pharmaceuticals, while an estimated 7 million Americans with the condition are still waiting for this procedure to be approved.” says Serge Bernasconi, Chief Executive Officer of Eucomed.
To clarify what is at stake with the current revision of the European medical device legislation, Eucomed has launched the campaign “Don’t lose the 3”. The campaign showcases the advantage that Europeans currently enjoy and explains what changes need to be made to the current European system to make sure that Europeans continue to have timely access to safe, live-saving medical devices.
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Positions, research reports, videos, visuals and other materials regarding the Revision of the Medical Devices Directive are available at the dedicated section of the Eucomed website.
About Eucomed
Eucomed is the European medical technology industry association. Its mission is to make modern, innovative and reliable medical technology available to more people. Eucomed represents directly and indirectly 22,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry generates annual sales of €95 billion, invests some €7.5 billion in R&D and employs around 500,000 highly skilled workers. Eucomed is a member of MedTech Europe, an alliance of European medical technology industry associations. For more information visitwww.eucomed.org
More information
Ingmar de Gooijer
Director Communications
E: ingmar.degooijer@eucomed.org
T: +32 (0)2 775 92 24
M: +32 (0)492 97 14 70
Contamac, the world’s largest material manufacturer of Intraocular and Contact Lens products, are delighted to announce the appointment of Sebastian Kic as Key Account Executive for our IOL material customers. Sebastian was born in Czestochowa, Poland, brought up and educated in Paris, France, before moving to and settling in the UK in 2003. In his previous role at GKN Freight Services he held various operational, customer-facing roles and spent last two years as their European Business Development Manager, focusing on generating additional revenue streams from both new and existing customers, as well as offering supply-chain support solutions.
Sebastian comments: “I have always worked in an international and multi-lingual environment and strived to deliver the best customer service, focusing on presenting improved service and unique solutions, the ability to deliver excellence and meet or exceed customers’ demands makes me feel satisfied and motivates me to aim and progress further. I always do whatever it takes to deliver to customers’ needs, irrespective of time zone difference and truly enjoy providing alternative solutions, resolving problems and taking the time to understand customers’ expectations. I am very happy to be part of Contamac and hopefully will use my experience and expertise to grow together and promote our organisation’s image and product portfolio.”
Simon Wyatt, Director at Contamac added, “I am very pleased to welcome Sebastian to Contamac as the Key Account Executive for our IOL material customers. Sebastian will manage our IOL customer accounts on a day-to-day basis, allowing Derek Wilson to focus fully on our joint venture with Contateq and the launch of our first hydrophobic material. David Golden, our Office Sales Manager, will provide further support to customers in our growing IOL materials market. Paul Hopgood remains the contact for processing sales orders and dealing with shipping, and Mary Hutchens, our Regulatory Manager, will continue to provide advice and assistance on all regulatory matters. I am delighted to have such a strong team to ensure we continue to provide the service and support our customers expect.”
California based SynergEyes Inc announces the launch of UltraHealth – a hybrid lens system aimed at irregular corneas and keratoconus sufferers.
Further details can be found here
Leading UK based materials producer Contamac Ltd has announced the launch of two new materials to be added to it’s “Definitive” range of latheable Silicone Hydrogel materials.
Further details can be found here
A reception in London on November 7th 2012 saw EFCLIN member Contamac Ltd earn the title of UK National Champion in the prestigious European Business Awards for 2012/13……….
Further details can be found here
The ECLF (European Contact Lens Forum) today issued a press release following it’s 2nd successful one day seminar in Amsterdam, NL.
Further details can be found here.
One of the best known figures of the Contact Lens Industry, Keith W Harrison passed away peacefully on Tuesday 21st August 2012 following his battle with cancer.
Further details here.
October 17th 2012, 11.00 – 16.00. More information available here.
Don Noack passed away on 28th June 2012 after a short illness. The following obituary has been issued by NZ Optics….
