Archive for the ‘EU Regulatory’ Category
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 ...
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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 ...
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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 ...
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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 ...
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Wednesday, March 23rd, 2011
A survey of medical technology industry associations conducted by Eucomed has identified several significant barriers that confront small and medium enterprises (SMEs) at the EU level. The barriers include inconsistent application of EU regulations, requirements that inhibit the commercialisation of new technologies, and limited access to R&D funding programmes and ...
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Monday, March 14th, 2011
The design, manufacture and shipping of electrical medical devices in the European Union could soon become more challenging because of new and proposed changes to the Restriction of Hazardous Substances Directive (RoHS) and Waste Electrical and Electronic Equipment Directive (WEEE). Instead of seeing these directives as inconveniences, the medical device industry ...
Posted in EU Regulatory, Electromedical equipment, Electronics, medtechinsider | Add Comment »
Sunday, January 30th, 2011
This should put a spring in your step as you begin the work week: the United States and Europe report roughly the same number of severe medical device recalls, yet the approval process in Europe is significantly faster. A report from the Boston Consulting Group (BCG) posted on the Eucomed ...
Posted in EU Regulatory, medtechinsider | 1 Comment »
Wednesday, September 1st, 2010
The debate on the reuse of single-use devices, which flares up from time to time, is on the front burner again thanks to a report from the European Commission. Eucomed has issued a press release welcoming the report whilst noting that it remains "typically neutral in terms of action at ...
Posted in EU Regulatory, Regulation, qmed daily europe | Add Comment »
Sunday, August 22nd, 2010
Pan-European trade association Eucomed has announced the full programme of the forthcoming MedTech Forum 2010. The event will feature discussions of such provocative issues as corruption in the healthcare system, the methodology and ramifications of health technology assessments and the way forward for medtech companies wrestling with a feeble economy. ...
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