An opportunity for true global harmonisation?

  • Posted on 11.12.2009

An opportunity for true global harmonisation?


John Brennan

Director Regulations and Industrial Policy


In an ideal world we would have the same rules on devices in each country.  As patients, as we live or travel in different countries, we can be confident that should we fall ill, the devices used to help us are as safe as the ones at home.  As businesses, we would be confident that the investments, jobs and benefits we create in one country can be easily further capitalised in another.

This is the goal of GHTF as I see it.  GHTF is successful, despite the founding members having to deal with the ‘legacy’ elements of their own systems.  Culture, history and local law all contrive to keep things just that little bit different.

But there is hope in sight. In areas where nobody has legislation yet, GHTF has the great opportunity to set out the common policy and let all countries and regions transfer that into their regulations. Sanity prevails and patients and businesses benefit around the world.

Just such an opportunity is upon us. Out for comment right now on the GHTF website is a document on something called ‘Unique Device Identification’ or ‘UDI’ as it’s more often known.  I won’t bore you with the detail but this is a device labelling initiative with a significant business impact on all companies.  Those not prepared risk having to spend millions to catch up.

But the good news is that if we get the document correct (simple, appropriate, realistic in expectations, implementable, risk based), then we end up with a potentially truly global solution.  So if I were you, I’d read the document, comment to the GHTF, and copy Eucomed so that we can make sure that, indeed, sanity does prevail.

John Brennan, Director Regulatory and Technical Affairs, Eucomed

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