Getting health ministers to attend the Eucomed MedTech Forum in October 2011 was a bit like pulling teeth, according to John Brennan, Director of Regulatory and Technical Affairs at Eucomed. If you were to extend an invitation today, they would be lining up to speak, he told MEDTEC Europe conference attendees last week. It’s amazing how a scandal or two can reset priorities. With this anecdote, Brennan set the tone for his paper on the industry position of the medical device directives revision. He presented his paper at MEDTEC Europe on 16 March 2012 in Stuttgart, Germany.
The public at large does not really know what to make of medical devices, said Brennan. Events such as the breast implant scandal and the metal-on-metal hip implant controversy define the device industry, which is otherwise amorphous, in the public eye. Some good can come from this sudden focus, he added, as long as public officials and industry seize the opportunity to explain how the device industry operates and what it hopes to achieve. “Our goals are to be safe, smart and sustainable,” he told attendees. “It’s as simple as that.” Brennan then projected a Powerpoint slide stressing that the recast of the device directives could sort out weaknesses in the system. It could have been drafted in reaction to current events, but, in fact, “the slide is actually three years old,” he wryly added. So, the underlying objective has not shifted. What has changed 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 for which Eucomed has advocated as the revision process has moved forward. Brennan reminded attendees of these steps, which are, in addition to overall transparency:
- a network of Notified Bodies that meet a rigorous set of qualifications;
- stronger harmonised standards;
- a unified approach to vigilance and postmarket surveillance;
- establishment of a consistent, transparent process for the implementation of guidelines;
- institution of an integrated approach that leads to improved coordination and management.
A smarter legal framework should not, however, overreach and become unduly restrictive. 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. Brennan 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. However, he 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.
The legislative proposal is now expected by June or July 2012 with first and second readings in 2014 and 2015 and implementation as late as 2018.
There is time to prepare for the revised directives, certainly, but complacency should be restricted to one cohort. “If you are in your late fifties,” joked Brennan, “you can chill and delegate the work.” For the rest of you, it’s time to get busy.Norbert Sparrow