Archive for the ‘Regulation’ Category

European Commission Issues Plain-Vanilla Report on Reuse of SUDs

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 ...

Conditional CE Marking — A Pathway to Innovation?

Wednesday, August 11th, 2010

The European Commission's public consultation on proposed revisions to the In Vitro Diagnostics Directive (98/79/EC) makes reference to "conditional CE marking," reports Clinica (subscription required). And that has generated some buzz in the couloirs at Eucomed and within the larger medtech community. Section 5.1 of the consultation states the following: For ...

Medtech Consultancy Emergo Opens German Office

Tuesday, August 3rd, 2010

Medical device consultancy Emergo Group Inc. has opened a new office in Hamburg, Germany, to meet the needs of a growing European client base. The Hamburg office is the group's fourth in Europe and will greatly expand the firm's ability to serve medical device and IVD manufacturers in Germany, Austria and ...

World First: Wipro Technologies Achieves IEEE 11073 Certification for Five Device Classes

Thursday, July 22nd, 2010

The x73 Manager USB Reference System developed by Wipro Technologies has received IEEE 11073 certification from industry organisation Continua Health Alliance. Wipro is the first healthcare IT services company to achieve this certification for five device classes: blood pressure monitors, pulse oximeters, weighing scales, thermometers and glucometers. The IEEE 11073–based ...

Updated EU Reimbursement Reports Now Available

Wednesday, July 21st, 2010

The entire catalogue of country-specific medical device reimbursement reports published by Factory Reimbursement has been updated. Additionally, reports are now available for two new markets: the Netherlands and Belgium. Formerly known as the Jacoti Reports, the ready-to-download documents offer comprehensive information about medical device reimbursement regulations in seven European Union countries. All ...

Pilgrim Software Launches Integrated Platform for Regulatory Reporting

Monday, July 12th, 2010

Pilgrim Software Inc., a provider of enterprise risk, compliance and quality management (ECQM) software, has announced the global availability of its expanded Regulatory Reporting platform. In addition, the company has introduced the MedDRA adapter, which integrates with its Complaints Management product to simplify adverse event reporting to global ...

Professor Gets Primer on Medical Device Regulation from BVMed

Wednesday, June 23rd, 2010

"Medical devices are not subject to any regulatory approval; [manufacturers] don't have to prove their effectiveness nor their safety." Would you believe that's what Professor Juergen Windeler, future head of the Institute for Quality and Economic Efficiency in Healthcare (IQWiG), claimed in an article published on 10 June in the German ...

Japanese Medtech Association Launches Think Tank, Cautions Against Burdensome Regulations

Tuesday, May 25th, 2010

Japan's first think tank focused on the medical device industry has been established. The Medical Device Strategy Institute (MDSI) will initiate research and generate dialogue on policy issues of interest. Among its projects is a paper on market trends spanning a quarter century. It is a noteworthy development because Japan’s ...

Eucomed and AdvaMed Sign Agreement on Ethical Interactions

Tuesday, May 4th, 2010

Two of the largest and most influential medical technology trade associations in the world have signed a trans-Atlantic statement on ethical interactions between medtech companies and healthcare professionals (HCPs). John Wilkinson, Chief Executive of Eucomed and Stephen J. Ubl, President and CEO of AdvaMed, which represents the US medtech industry, ...

New Clinical Trials Service Based on the Bayesian Method

Monday, March 29th, 2010

Cambridge Consultants, a technology product design and development company, has announced it is to offer a new consultancy service for medical device clinical trials that will save clients time and money through a more effective method of analysing trial data. This news follows the announcement of the US Food and ...

Revising Directive’s Time-of-Use Clause May Cause Reclassification of Devices

Tuesday, March 9th, 2010

Medical device manufacturers are required to comply with Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC by 21 March 2010. Despite having made every effort to meet the essential requirements, companies may be surprised to learn that the classification of some of their devices may be challenged, writes René ...

Notified Body SGS Expands into IVD Certification

Monday, February 1st, 2010

SGS has extended its medical device Notified Body status to include Directive 98/79/EC for in vitro diagnostic (IVD) medical devices. The company’s initial scope of designation as an IVD Directive Notified Body includes all LIST B devices and Self-Test IVD devices. This scope will be further expanded to include all ...