Archive for the ‘EU Regulatory’ Category
Friday, April 27th, 2012
The Pip resolution, drafted by the Environment and Public Health (ENVI) Committee of the European Parliament and unanimously passed on 25 April, is a mixed bag, according to Eucomed. The pan-European association applauds many of the measures, including greater oversight of Notified Bodies, more robust vigilance reporting, the introduction of unannounced ...
Posted in EU Regulatory, Regulation, medtechinsider | 2 Comments »
Thursday, April 12th, 2012
As more and more healthcare apps enter the marketplace, manufacturers increasingly will wrestle with complex regulatory issues that don't always have a clear path to compliance. For example, as functionality is added to software used in a healthcare setting, it can become a medical device in legal terms, writes ...
Posted in EU Regulatory, Electronics, medtechinsider | 2 Comments »
Wednesday, March 21st, 2012
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 ...
Posted in EU Regulatory, medtechinsider | 1 Comment »
Wednesday, March 14th, 2012
The final e-labelling regulation that was just published in the Official Journal is truly a missed opportunity, writes Eric Vollebregt on his medicaldeviceslegal blog. "As you will see when you run a compare (like I did), there is absolutely no change compared to the last version that was available ...
Posted in EU Regulatory, medtechinsider | Add Comment »
Thursday, March 8th, 2012
From the wire: Appropriate procurement mechanisms, whereby small and medium sized enterprises (SMEs) have equal opportunities, innovation is stimulated and Europe’s market attractiveness and competitiveness upheld, can contribute significantly towards sustainable European healthcare systems, with safe, more efficient innovations being available to more people, writes Eucomed in a press ...
Posted in EU Regulatory, Industry News, medtechinsider | Add Comment »
Tuesday, November 22nd, 2011
EMDT's conference Managing Regulatory Change for Medical Devices will take place next week, 30 November-1 December at the Westin Grand in Berlin. The conference will offer practical solutions for how to identify, navigate and implement regulatory requirements.
Posted in EU Regulatory, Regulation, medtechinsider | Add Comment »
Monday, November 7th, 2011
Last week, Eucomed CEO John Wilkinson defended the medical devices regime in Europe in a blog post titled "What did Europe ever do for us?" The answer to that question, Wilkinson stated, is "a lot". Pan-European collaboration when it comes to regulation and standards have dramatically reduced the risk to ...
Posted in EU Regulatory, medtechinsider | Add Comment »
Thursday, October 13th, 2011
Patients are waiting up to two years for cataract surgery in Ireland, reports the Irish Times, and that is not unique to Ireland. To eke out savings in a precarious economy, governments are leaving no stone unturned, including discouraging noncritical interventions. Catherine Mazzacco, Vice President, Global Commercial Operations, Abbott Medical ...
Posted in Conferences, EU Regulatory, medtechinsider | Add Comment »
Sunday, September 11th, 2011
Sharon Higgins, Director of the Irish Medical Devices Association and Chair of the Eucomed SME Task Force, recently penned her first blog post, in which she discussed the pivotal role played by small and medium sized enterprises (SMEs) in the development of medical technology. She also took that opportunity to ...
Posted in EU Regulatory, Trade Associations, medtechinsider | Add Comment »
Friday, July 15th, 2011
Since EU regulations on electronic labelling and instructions for use (IFU) may enter into force by the end of 2011, the medtech community needs to be aware of what is at stake. Erik Vollebregt, a Dutch lawyer patrolling the crossroads of EU regulation and medical devices, provides an excellent overview ...
Posted in EU Regulatory, medtechinsider | Add Comment »
Wednesday, June 8th, 2011
Medically geared mobile phone apps and e-healthcare initiatives continue to cause concern among industry observers. At what point does a healthcare-related app turn into a medical device and become subject to the associated regulatory requirements? On this question, Erik Vollebregt, a Dutch lawyer specialising in medical technology issues and inveterate blogger, ...
Posted in EU Regulatory, Telemedicine, medtechinsider | 1 Comment »
Monday, May 23rd, 2011
It has been a banner week for ethics (or at least for the promise of engaging in ethical behaviour) in the medtech realm. Following the publication earlier last week of a Notified Bodies code of conduct, nine medical technology associations have signed the “Global Compliance Statement on Interactions between Medical ...
Posted in EU Regulatory, medtechinsider | Add Comment »
