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Medtechs Must Act Fast On New EU Regulations Or Face Gridlock

Following the recent vote in the European Parliament, the EU has finally adopted the Medical Device and IVD Regulations that were proposed back in September 2012. The texts, vastly longer and more complex than the three directives they are replacing, will establish a tougher regulatory code for the next decade or more, but where are the likely pressure points for industry and how can manufacturers prepare?

Regulation Market Access Medical Device
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Medical Devices Aren’t Luxury Goods, So Why Does Medtech Try To Sell Them That Way?

Clinical outcomes, quality and total cost of care are driving hospital purchasing decisions more than ever before. Providers can no longer justify spending on medical devices as clinical luxuries without links to outcomes. ZS recommends five fundamental factors that medtech needs to successfully communicate outcomes-based value.

Commercial Business Strategies

The Rozy View: Medtechs, Negotiate With India’s Regulators And Don't Give Up On Japan

Late to the regulatory game India's government authorities may be, but device companies need to be on their toes to not lose out on vast future market opportunities as the "Make in India" program takes shape. That is the view of international device regulatory and market access expert Ed Rozynski. And while India is on the up, is Japan losing its attractiveness?

Market Access Asia Pacific

To Get Pricing Right, Pharma Must Understand Payer Behavior, Trump Or No Trump

When it comes to drug pricing, one size certainly doesn’t fit all. Biopharma firms need to devise and design appropriate pricing and commercial strategies for payers, a group of customers that don’t all care about the same things and, in some cases, whose needs may be diametrically opposed.

Reimbursement Pricing Debate

Trump's Sights Set On Payers And Pharmas, But Medtechs Must Not Be Complacent

It's been a big month for plans intended to shape the future of health care in the US, with the Trump Administration showcasing its ACA replacement bill and issuing budget proposals. At this stage, it's hard to peg winners and losers and although the focus is squarely on insurance, the medtech sector should guard against complacency, says ZS Associates' Brian Chapman.

Medical Device Regulation

Brexit Podcast: Next Steps For The UK Medtech Industry

Free: In Vivo's Ashley Yeo talks to Association of British Healthcare Industries' Nishan Sunthares and Richard Phillips about the subject that will dominate the thoughts, behavior and business of medical technology companies in the UK for many years to come.

Brexit Regulation

Integrated Health Care Europe-style Is Here – Get Used To It

The era of integrated health care has arrived, at least as far as the European medical technology industry is concerned, where the devices and IVDs industry associations have merged under the umbrella name MedTech Europe. MTE chairman Rob ten Hoedt explains what this means in practice.

Market Access Europe
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