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Until recently economic and regional integration in the post-Soviet countries to a large extent was only declarative. However, the initiative of going beyond the Customs Union (CU) to create Common Economic Space (CES) between Russia, Belarus and Kazakhstan draws attention to potential market opportunities and at the same time regulatory challenges for the MedTech industry.

Only a few days ago, I heard those words for the first time. Me? Writing a blog? Hmmm, ok, there could be an opportunity here… And now I am looking at a blinking cursor inviting me to put down a few thoughts and ideas.
Well, why don’t I start by answering a few questions “Why now? Why not 3-4 months ago, Serge? How often can we expect to read your posts? And what will you be talking about?”

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.

Let’s face it – ostomy care is not something most people are keen to talk about. But that’s all the more reason we support World Ostomy Day on the 6th of October. Through our work, we often meet people who have had life-saving ostomy surgery. What never ceases to amaze us is the profound impact an ostomy can have on people’s lives. Yes, they’ve lost continence but they can also lose confidence – the confidence to work and to socialise.

I have always found that no matter how much a person looks forward to a change, there is still that little tad of reluctance – a fear that things may not turn out for the better. The hesitation, even if momentary, manifests itself in the simple and mundane everyday tasks like clicking install for a computer software update or taking life’s big leaps, like getting married. The concern for what the change may bring is all the greater when you didn’t really mind the way things were in the first place. From my experience, some of us in the in vitro diagnostics (IVD) industry are also experiencing a bit of such reluctance when it comes to the revision of the IVD directive. Especially when it has worked fine since 1998, so why the change? A reasonable question, but considering the differences that have arisen between the healthcare context of the late 1990s and today, it’s time that our industry give the proposal careful consideration in the lead up to its approval, taking into account the impact of each of the legislation’s proposed aspects.

You’ve heard me proclaim the importance of MedTech SMEs before on this platform and I reckon you’ll hear me again. You’ve heard me tell you that SMEs are the backbone of this industry – that as 80 plus percent of a 95 billion euro industry they are what makes the sector tick, launching innovative technology on a rolling basis and driving European healthcare forward onto a sustainable path. Well it appears I’m not the only one keen to sing the praises of our brilliant community of big thinkers. MedTech SMEs are gaining new ground in Europe as more people realise the promise they represent.

For the past two years, I have been working with great passion on the subject of mobile health (or mHealth), having set up the global mHealth programme of the GSMA – the organisation that represents the interests of mobile operators worldwide. I am therefore very pleased that the momentum for mHealth has really been building.

The long anticipated revision of the Waste Electrical and Electronic Equipment (WEEE2) Directive (2012/19/EU) was published in the Official Journal, L197, on the 24th of July 2012. The Directive arrives just over a year after its sister Directive 2011/65/EU on the Restriction of Hazardous Substances (RoHS2). The stated aim of WEEE2 is to:

Lately I hear and read a lot of people asking for a Pre-Market Authorisation process for medical technology in Europe, or PMA process as it’s known, similar to the one in the US. Even the European Parliament voted (narrowly) for a resolution in which they call for a PMA approach. And that made me think, hold on a second, don’t we already have an approval system in Europe for high risk products?