Archive for the ‘EU Regulatory’ Category
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. ...
Posted in EU Regulatory, Forums, medtechinsider | Add Comment »
Wednesday, June 23rd, 2010
The medical technology sector in France registered virtually no growth in 2009, a new low for an industry that has seen its growth rate plummet from 5.43% in the period between 2006 and 2007 to 1.41% between 2007 and 2008. The statistics were announced this week in a press release ...
Posted in Assembly systems, Business News, EU Regulatory | Add Comment »
Thursday, June 17th, 2010
Cranfield University in the United Kingdom has announced a new short course titled Medical Technology Vigilance: Postmarket Surveillance (PMS) and Risk Management. The three-day course, which is scheduled for 21 to 23 September 2010, will define the terminology and explain the concepts of vigilance, PMS and risk management, their practical ...
Posted in Announcement, EU Regulatory, Seminars, medtechinsider | Add Comment »
Thursday, April 8th, 2010
Cranfield University has announced a three-day course next month titled Management of Regulatory Affairs and its Contribution to the Medical Technology Lifecycle. It will provide students with an understanding of the skills required to control regulatory affairs departments and to achieve worldwide compliance and approvals, according to the university. This ...
Posted in EU Regulatory, Seminars, US Regulatory, medtechinsider | Add Comment »
Tuesday, November 10th, 2009
Medicoindustrien, the Danish medical technology trade association, is launching a series of seminars for 2010. The subjects are currently under development, but will place a special focus on relevance and timeliness and be organised at short notice. The seminar programmes are being developed by the association’s expert groups and members, ...
Posted in Conferences, EU Regulatory, medtechinsider | Add Comment »
Tuesday, September 22nd, 2009
Intertek, a provider of quality and safety services and ENVIRON, an international environmental consultancy and manager of the industry-led substances declarations web database www.BOMcheck.net, are hosting a free webinar on the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals' (REACH) Substances of Very High Concern (SVHC) and the expanded ...
Posted in EU Regulatory, medtechinsider | Add Comment »
Friday, September 18th, 2009
Notified Body BSI has launched CE-Dedicated FastTrack, a CE marking programme that is designed to help medical device manufacturers get their products quickly and safely to European markets. BSI introduced the programme at the 2009 Regulatory Affairs Professionals Society (RAPS) Annual Conference, which took place September 13–16 in Philadelphia.
CE-Dedicated FastTrack provides ...
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Saturday, May 30th, 2009
The Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) Regulation deals with chemicals and their safe use. Article 33 (1) of the Regulation requires contract manufacturers and distributors who supply an article (product) that contains more than 0.1% weight by weight (w/w) of any Candidate List Substance of Very ...
Posted in EU Regulatory, medtechinsider | Add Comment »
