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World Health Day approaching us on April 7^th is meant to raise awareness on the endless host of hurdles that undermines our health and therefore, our quality of life. Public health is about making sure that the external factors that determine our health are governed by policies that have people’s well-being at the very heart of their mandate. EPHA, Europe’s leading NGO advocating for better health, is committed to that very principle.

This year marks EPHA’s 20^th anniversary in advocating EU and European policy-makers on public health. Bringing today’s leaders to focus on people’s health is not an easy task. The medical devices and in vitro diagnostics files appropriately represent the juggling effort that advocating for public health usually turns out to be.

Just Dance. People love dancing, whether it be for fun, as a workout or professionally as a dancer performing choreographies with great passion in front of an audience. This passion has resulted in a hip surgery for Lady Gaga, the American singer-songwriter known for such hits as Bad Romance, Poker Face, and – appropriately – Just Dance. For fans all over the world, the hip fracture was a synonym for cancelled concerts and missed opportunities to meet their idol. But why did this happen so suddenly? Why did we not hear about her problems earlier?

By now most of you will have noticed that we have launched our “Don’t Lose the 3”-campaign. (If you haven’t, watch the 1-minute video and patient stories here. The basic message of the campaign is that, thanks to our decentralised approval system for medical devices in Europe, Europeans have access to life-saving and life-enhancing technologies three to five years before US patients without compromising safety. This is also the message I brought forward during the 26 February hearing of the ENVI committee at the European Parliament.

How many of us have elderly friends and relatives who have spent time in various healthcare settings?  Were you aware of the risks associated with that care?  Did you know whether your loved one was risk-assessed or properly repositioned to prevent the development of a pressure ulcer?

The upcoming MDD revision can learn a lot from a 2007 mistake in woundcare regulation.
Burn wounds result in some of the most horrific pictures one can come across as a surgeon. Burn victims not only have to suffer the immediate pain associated with burn wounds, but also have to deal with often permanent scar tissue, a lifelong reminder of that terrible moment.

If there is one thing that the medical devices industry agrees on it is that the new proposals for medical devices and IVD regulations are welcome and necessary evolution of regulation. What the industry also agrees on is that although it generally supports the new proposals, it is not certain at all that the proposed scrutiny procedure will achieve the intended goals.

First off, let’s start with some background. The first question that comes to mind would be: “What is the EUnetHTA Joint Action 2?” Briefly put, EUnetHTA, the European Network of Health Technology Assessment, is a joint initiative of the European Commission and the relevant agencies in the Member States, aiming to strengthen cross-border HTA collaboration.

When we speak about healthcare in Europe, the word ‘sustainability’ is used often. From the outset of the economic crisis in 2008, policymakers, ministries of health, customers and payers all have focused on sustainable financial systems and sustainable healthcare systems – often as separate paths to achieve results. As budgets are shrinking, innovative ways to maintain current social and healthcare systems for the long term must be employed. At CleanMed Europe, a conference that brings environmental and healthcare issues together on the same agenda, I was pleased to see that a broader alternative discussion is emerging—one that marries financial and systemic sustainability in healthcare.

The European Commission’s proposal to revise the medical device legal framework is a welcome step towards strengthening and improving the EU regulatory system. Recognised globally as being the fastest in providing life-saving technologies to patients without compromising safety, this thorough overhaul of the regulatory system seems to be mostly in line with Europe and President Barroso’s stated policy of ‘Smart Regulation’: ensuring the quality and relevance of EU legislation, which should benefit people and businesses.