Archive for the ‘EU Regulatory’ Category
Wednesday, May 15th, 2013
Last month, we reported on progress in setting the foundations of a harmonised unique device identification (UDI) system. US FDA seems to be on track to present its final draft of a UDI system to the International Medical Device Regulators Forum (IMDRF) in November 2013, and a consensus has formed ...
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Sunday, April 14th, 2013
While there is much uncertainty regarding the details of a unique device identification (UDI) system that is in the works in the United States and Europe, progress is being made. The International Medical Device Regulators Forum (IMDRF), which picks up where the defunct Global Harmonization Task Force left off, announced ...
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Thursday, March 14th, 2013
From the Consultant’s Corner Newsletter, March/April 2013
Revision 8 of MEDDEV 2.12-1, the new European medical device vigilance guidelines, will replace the current version in July 2013. Are you ready? The time is right to ask the question, since you may need to update your vigilance procedure.
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Thursday, February 28th, 2013
Yes, Europe's regulatory system for medical devices is in need of an overhaul to improve patient safety and maintain timely access to innovative medical technology. No, the scrutiny procedure is not the best way to achieve that goal. That was—almost—the consensus at a meeting organised by the European Parliament’s Environment, ...
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Wednesday, February 20th, 2013
Much ink has been spilled over the scrutiny procedure in the proposed medical device regulation, but relatively little has been said about article 16, which would require an "implant card" to be distributed with each implantable device and provided to the patient who has been implanted with the device. Rolande Hall, ...
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Thursday, January 31st, 2013
As promised by MedTech Europe CEO Serge Bernasconi in his baptismal blog post earlier this week, Eucomed has published its formal response to the new EU medical device regulations that are before the European Parliament. While Eucomed and industry favour many of the proposed measures, the scrutiny procedure has been a significant ...
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Monday, December 17th, 2012
The Irish Medical Technology Industry Excellence Awards, which were held in Galway, Ireland, on 13 December 2012, provided an object lesson on everything that is right with the medtech industry. Performing well in an otherwise dodgy economy, with exports up year on year, Ireland's medtech sector celebrated its achievements at ...
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Monday, November 26th, 2012
The European Parliament grilled Tonio Borg for several hours last week before he was approved as the new European Health and Consumer Protection Commissioner. In an interview with Malta Today, Borg reached out to the MEPs who voted against him and said he wants to meet and work together.
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Monday, November 12th, 2012
New details are emerging in the scandal surrounding former EU health commissioner John Dalli and the nomination for his successor, Tonio Borg. Liberal members of the European Parliament have expressed strong criticism over Borg's conservative social views, with Swedish MEP Cecilia Wikstrom leading the outcry by calling Borg "a dinosaur." Meanwhile, ...
Posted in Electronics, EU Regulatory, Orthopaedics | Add Comment »
Thursday, October 18th, 2012
The European Union has released new information into fraud allegations related to former European Health Commissioner John Dalli, who resigned this week after the European Anti-Fraud Office (OLAF) completed an investigation into the case. Tobacco producer Swedish Match filed a complaint in May 2012, saying that a Maltese businessman tried ...
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Thursday, October 11th, 2012
The global CEO panel on day two of MedTech Forum 2012 in Brussels started off like a bit of a cold shower. We must stop “patting ourselves on the back and take stock of reality in southern Europe,” said Alexandre Conroy, President, EMEA, BD. It’s not a pretty picture, as ...
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Wednesday, October 10th, 2012
Do I detect a trend? As one tweeter noted, "value-based innovation" is one catch phrase that has crossed the Atlantic from the Advamed conference in Boston a couple of weeks ago to MedTech Forum in Brussels this week. In fact, this emphasis on a changing business model is largely a ...
Posted in Business News, EU Regulatory, Forums | 5 Comments »
