Am I the only one that feels an urge to bang my fist on my desk in sheer frustration at the European Commission regulatory document footnote of which it is so fond?

Is it out of laziness, or a desire to ensure accuracy, that the Commission lawyers add this apparently innocuous little reference which has the reader left hanging as to the exact legal implications?

Or is it the European Commission’s desire to keep regulatory documents as short as possible in the current environment of pressure to cut red tape, and at least make them appear less lengthy, even if they are less comprehensible?

To be honest, it is not just the European Commission that does it. In my experience, French legal documents are full of unexplained references which should be easy to follow up on in this internet age, but simply are not. And I am sure other countries are guilty of this heinous crime too.

So it is back to the source document. And so often it is. But I would be able to understand it so much more quickly if the reference was explained there and then or, at the very least, have the full explanation appended to the document.

After what is often a 10-20 minute Google search – I have no idea why it always takes so long, but it does – the relevant secondary text is found. But by then, the train of thought within the context of which the secondary document was being sought - interrupted also by phone calls and offers of a cup of tea - has become slightly vague and confused.

In the latest case, I was researching the alternatives facing medtech companies during the period when the Machinery Directive enters into force on December 29. I was reading the European Commission’s recent so-called “Interpretative Document” on the implementation of the revised medical device directive (Directive 2007/47/EC).

“Interpretative”? Someone in the Commission is having a laugh at our expense – there are 12 footnotes in this document!

Returning to this specific incident, the revised medical device directive comes into force on March 21 2010 and makes clear that medtech companies manufacturing machinery have three options between December 29 this year and March 21 next year (www.clinica,co.uk, December 9 2009).

One of these is to anticipate the requirements of the Machinery Directive while otherwise complying with the requirements of the current relevant Medical Device Directive, “including the usual regime regarding change control (see above under 3, in particular footnote 11)”.

Not entirely sure of this term “change control” and wishing it was spelt out, I am horrified when turning to the above cited footnote, to find the reference:

Point 3: 11: see points 3.4 and 4.4 of Annex II, point 6 of Annex III, point 3.4 of Annex V or point 3.4 of Annex VI of Directive 93/42/EEC: point 3.4 and 4.4 of Annex 2, point 6 of Annex 3 or point 3.4 of Annex 5 of Directive 90/385/EEC.

And I won’t tell you what these are – just to let you experience the feeling of hanging in limbo too!

If it is out of a desire for accuracy that the footnote is included in the text, then please consider: how many people know these references by heart? How many people would you risk not following the footnote and making presumptions? How many will have the patience to really follow through the search and make the correct connection between the two texts?

In my view, footnotes are a bad idea. In this internet age, we are used to immediacy of information, and few have the patience for them.

Perhaps, the European Commission has got away with them this far because these documents are agreed upon by people with a legal or regulatory background.

But, I beg you DG Sanco, when considering the recast of the medical device directives, please make reading legal documents easier, more immediately transparent and less time-consuming for all your readers – be they lawyers, or small companies otherwise robbed of time spent of research, development and manufacturing, or simply a journalist trying to explain what they mean.