Packaging Waste Directive Compliance in Europe

May 2007
Published in the Journal of Medical Device Regulation
In depth article written by Emergo Group explaining the European Packaging Waste Directive and its application to medical device and IVD comapnies.
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How to Select a Notified Body

May 2007
Emergo Group Inc.
Article discusses how medical device and IVD companies should evaluate and select a Notified Body for their ISO certification and ongoing audits.
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Choosing an Authorized Representative for Europe

May 2005
Emergo Group article for Medical Product Outsourcing magazine - May 2005
Article that covers the basics steps to analyzing and choosing an EU Authorized Representative (EC Rep) in Europe.
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Green Dot Expands to Romania and Estonia

January 2005
Emergo Group, Inc
PRO-Europe represents the packaging and packaging waste collection schemes for the European Union and Canada. In late 2004, PRO-Europe welcomed Estonia and Romania...
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European countries where CE Marking is required

Tuesday, March 27, 2007
Emergo Europe - The Hague, The Netherlands office
In 2007, the European Union expanded to 27 countries representing 24 different languages...
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Do you need an FDA Export Certificate?

2005
FDA
Clients often call us because one of their overseas customers (or a government agency) has asked them to supply an FDA Export Certificate...
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FDA REQUIRES NON-U.S. ESTABLISHMENTS APPOINT A U.S. AGENT

Emergo Group, Inc - Clearwater, FL office & FDA
Published in the November 27, 2001 Federal Register, Section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) foreign (non-U.S.) establishments engaged in the importation to the United States...
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EU COUNCIL OF MINISTERS REQUESTS EUROPEAN DATABASE FOR MEDICAL DEVICES

March 2004
Emergo Group, Inc - Austin, TX office
The European Union's Council of Ministers has invited the European Commission to set up and maintain a European database for medical devices.
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What is the GHTF (Global Harmonization Task Force)?

December 2004
Emergo Asia Pacific Pty Ltd - Sydney, Australia office
The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry...
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The Packaging Waste Directive: What it Means for IVD/Medical Device Manufacturers

December 2005
Emergo Europe - The Hague, The Netherlands office
The European Union has endeavored to regulate packaging and to promote recycling since the mid-1980s. However, many of the early packaging waste regulations did not clearly establish the link...
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Updates on the General Product Safety Directive

March 2005
Emergo Group, Inc. - Austin, Texas office
The General Product Safety Directive was developed to establish safety requirements for consumer products not regulated by sector legislation (the way medical devices or machinery are). Essentially, the directive...
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INCREASE IN EU SURVEILLANCE OF PACKAGING AND PACKAGING WASTE

June 2004
Erin Branch, Emergo Group
The appropriate European Union authorities are becoming more vigilant in their desire to increase and improve surveillance regarding the Packaging and Packaging Waste Directive (94/62/EC) within the EU member states.
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CURRENT INSIGHTS ON POST-MARKET SURVEILLANCE AND VIGILANCE OF IVD DEVICES WITHIN THE 98/79/EC DIRECTIVE

August 2004
Reprinted from RAPS Focus magazine
As of December 7, 2003, the European In-Vitro Diagnostics Devices Directive - 98/79/EC (IVDD) requires that all IVD devices which are placed on the market in the European Economic...
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THE MANUFACTURER'S RESPONSIBILITY FOR THE QUALITY OF THE SUBCONTRACTOR'S PERFORMANCE OF QUALITY OF THEIR PRODUCTS

March 2003
Co-Ordination of Notified Bodies Medical Devices
According to Medical Device Directive Annex II, item 3.3, Annex V, 3.3 and Annex VI, 3.3 or IVDD Annex IV, item 3.3 and Annex VII, item 3.3 an inspection on the premises of the manufacturer’s subcontractor will take place in duly substantiated cases.
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Who Needs the CE Mark? A Primer for Medical Device Manufacturers

Tuesday, March 27, 2007
Written by Emergo Group, published in Medical Product Outsourcing magazine
Article provides an overview of CE Marking as it relates to medical devices.
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