The MedTech Europe blog

You better watch out!

Yesterday, we at Eucomed had our Christmas party (Happy Christmas everybody and a big thank you to all the Eucomed members and staff for everything in 2010!!). And while thinking back at yesterday’s little get-together, it’s dawning on me that with 2011 just around the corner we will be just over two and half years since the original public consultation on the recast of the EU medical devices legislation.

Has much happened in the meantime? Well everything and nothing really.

At the Eucomed level and EU level we had: Positioning; Engagement, Postponement, Exploratory Process, European Parliament Elections, New Commission, responsibilities for Medical Devices moves from industry to health at the Commission level (DG SANCO), Re-engagement with new European Parliament and Commission, meetings with the new Health Commissioner, John Dalli, further meetings with the new Chief of DG SANCO, Paolo Testori Coggi and her staff at DG SANCO, Medtech Forum Innovation Union and (ever so slightly) revised Commission Roadmap.

But for all of this, there is still no publicly available text. Not even an early draft. So in a sense, there is nothing.

So “Is there really a recast?” you may ask. It’s the same question as “Is there really a Santa Claus?”. And both have the same answer: Yes (just in case my kids are reading this).

And this ‘yes’ will really be apparent next year. Already 2011 looks like this: Eucomed/AdvaMed Joint Meeting on Recast (Washington, Jan 11 & 12 – do come), Eucomed/Commission high level workshop on Recast, EU High Level Conference on Innovation and Recast, Impact Assessment on Recast, Draft Texts, Targeted Consultations, MEP briefings, Medtech Forum, Meetings with Commissioners etc. etc.

Busy times. But with the continued support of a wonderful membership and Board, and working together with the whole Brussels stakeholder group – patients, healthcare professionals other associations and the institutions – it should be engaging, worthwhile, effective and, last but not least, FUN!

You better watch out! Better not cry! Better not pout! I’m telling you why, The Recast is comin’ to town…

Happy Christmas

– John Brennan
Director Regulatory and Technical Affairs

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  1. Thanks for the heads-up note.

    We (including the healthcare and Medtech industries) have all been in anticipation of the Impact Assessment on Recast, how the industries adjust and respond to the changes.

    I for one, as an independent medtech consultant do acknowledge the benefits of the current system and the need to improve certain areas, most notably how the notified bodies operate across the board, transparency; robustness of vigilance and the overall management of our European legal framework.

    It looks like 2011 is heavily packed with high level workshop on the Recast and meetings with Commissioners, etc. With the Commission’s proposal for a Committee on Medical Devices to better coordinate harmonised implementation of the Directives and that this Committee should sit under the umbrella of the European Medicines Agency (EMA) as an equal but separate function alongside the current pharmaceutical function. This has raised eyebrows in the industries. One may ask, is the gray area thinning for a clearer distinction on the remits of agencies and the legal framework or are we to expect more grey hairs thinking about how efficiently the regulatory systems should work?

    Busy times ahead but fingers crossed, these meetings are to throw more light on things to help industries see clearer and a well-defined direction for growth.

    Happy New Year

    Dr. Gabriel Adusei

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