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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.

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.

In summer of 2011, the EU’s Central Management Committee’s (CMC) published “Decision No 3”, requiring the placement on medical devices of the full postal address of manufacturers and authorised representatives. Since then, Decision No 3 has had the European medtech industry scratching its head in confusion. As we see it, the adoption of the decision has already led to great legal uncertainty, and implementing it in its current form would serve only to increase bureaucracy and additional, unnecessary costs.

There has been so much media and political focus on the medical device legislation in Europe in the first four months of 2012 that one could be forgiven for losing track of what’s exactly going on and where we are exactly in the process.

Having read Commissioner Dalli’s analysis of the PIP case and the Commission’s plans for strengthening the medical devices directives, it becomes clear that the medical technology industry and the Commissioner share the same view on safety and innovation.

Since the French authorities made their announcement just prior to Christmas, the PIP case has generated a large amount of press and political attention. Quite rightly, the main focus is on the women affected and on governments providing the right health advice and appropriate follow-up. As I am writing this posting a couple of days after we released our first statement, I understand that the European Commission is to seek an independent scientific opinion on the human health risks of silicone breast implants.

As the Euro zone crisis threatens to precipitate a much more fundamental questioning of the European dream, it is easy to revert to the eurosceptic homeland of vilifying apparently meaningless rules and regulations that have little real impact on the lives of any of us. The likes of the British ‘save our pint’ campaign trivialises the debate and does little to educate the voters of member states as to the real issues at stake.

Next week, pharmaceutical, biotechnology and medical device companies will change the way they interact with consumers on Facebook. These changes are occurring, not based on new communications strategies or industry regulations, but because Facebook itself is changing its policies.

The European Commission published on 1 June its long-awaited regulation proposal on European standardization. The document consists of the proposed legislative measures which update and consolidate existing EU legislation as well as impact assessments and non-legislative measures such as a strategic vision for European Standards. There were also a number of recommendations aimed at other actors in the EU Standardization system. I am convinced that these proposals are a significant step forward in the development of standards as an essential tool in developing the EU single market.