No Fear For Industry In Device Directives Revisions… Well, Not Yet

“Our goals are to be safe, smart and sustainable. It’s as simple as that.”

In short

We’re grateful to Medtechinsider’s Norbert Sparrow for covering a speech from Eucomed’s John Brennan at Medtec Europe in Stuttgart last week.

Brennan presented his paper on the industry position of the medical device directives revision. The full medtechinsider report can be found here. We’ve picked out a few themes, remembering of course that Eucomed’s position is that of protector of its members, so it’s not likely to be advocating a regulatory system that is too restrictive.

Could current controversies give us an opportunity to communicate?

According to Mr Brennan, controversies such as the PIP breast implant scandal and the extremely widely publicised metal-on-metal hip problems, characterise and define the industry on the public’s mind. He thinks “some good can come from this sudden focus, as long as public officials and industry seize the opportunity to explain how the device industry operates and what it hopes to achieve.”

In other words, MHRA should employ a better PR agency.

Renewed sense of urgency

The piece states that while the underlying objective has not changed, there is a newfound urgency among public officials and members of industry to communicate more effectively and more transparently with the public.

Indeed, transparency is one of the six steps of a smarter legal framework, which Eucomed has advocated as reported on our pages last November, here.

We’re not 100 percent sure what this means, transparency being such an obvious thing to seek and such a nebulous thing to achieve. We “think” he means that the public will be reassured if it sees more evidence of “regulation” or at least “regulators”. The trouble is, the media is never all that interested until something catastrophic occurs.

Risk of over-regulation

Unsurprisingly Eucomed is rather keen that a smarter legal framework should not become unduly restrictive. According to the article, “When Brennan told attendees that the revision, as it stands, contains about 350 individual paragraphs, one could wonder if the Commission was not headed down that dark path.”

Furthermore he acknowledged that Eucomed was “closely watching” some elements of the revision, such as the not-surprising emergence of a more restrictive approach to the review of what may be considered “high-risk” devices.

From our distant perspective we interpret that as a desire among regulators to move towards FDA PMA style regulation for higher risk devices. And in all honesty, how sustainable is it for US regulators to turn down PMA submissions on the basis of poor clinical findings while all the time the very same products are on the market in Europe on the basis of much lower clinical study requirements?

Mr Brennan reassured attendees that the document, taken as a whole, is more of an “evolution than a revolution.” Brennan expressed confidence that the proposal will be something with which industry can live fairly comfortably.

Sense of urgency?

The legislative proposal is expected by June or July 2012 with first and second readings in 2014 and 2015 and implementation as late as 2018.

Source: Medtechinsider