Articles

• Updated on Jul 16, 2009

  Medical Device Registration in Italy

  Synopsis of Italian Medical Device Registration “With reference to art. 14 bis European Data Bank as per 93/42/EEC Directive – 2002 Edition we inform you that on 20th February 2007, Italian Ministry of Health enacted a Ministerial Decree concerning the Registration in the Medical Device Inventory.” The above mentioned Registration into …. » more
• Updated on Dec 28, 2008

  Technical Abbreviations

  This page provide a list of confusing terms that trouble even the best of us. We hope that this page provides some insight into the world of EU regulatory Compliance. CDRH Center for Devices and Radiological Health, FDA. CE Marking CE Marking Approval marking for products being shipped into the 15 …. » more
• Updated on Dec 28, 2008

  Only Representative

  An Only Representative will take care of your compliance and obligations under REACH. This includes not only the registration, but also the authorization, classification/labeling, notification, and restrictions (where applicable) which may be necessary for your substances, as well all administrative procedures. Benefits include: Does not demand exclusivity and you are free …. » more
• Updated on Dec 28, 2008

  Free Sales Certificate

  Free Sales Certificate Many non-European countries request a personalized Free Sales Certificate from the manufacturer in order to place their device within that specific country. According to the European Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC, CE marked and properly registered devices in all 27 EU member states …. » more
• Updated on Dec 28, 2008

  Directive IVD 98/79/EEC Article 9,7

  Directive IVD 98/79/EEC Article 9,7 excerpt The manufacturer must keep the declaration of conformity, the technical documentation referred to in Annexes III to VIII, as well as the decisions, reports and certificates, established by Notified Bodies, and make it available to the national authorities for inspection purposes for a period ending …. » more
• Updated on Dec 28, 2008

  Notified Bodies for Medical Device Directive 93/42/EEC products

  List of notified bodies under directive 93/42/EEC Medical devices: The list of Notified Bodies can be downloaded as pdf. » more
• Updated on Dec 28, 2008

  CE Marking for European Directives

  European Regulatory Language Requirements CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called Product Directives which contain the “essential requirements” and/or “performance levels” and “Harmonized Standards” …. » more
• Updated on Dec 28, 2008

  WEEE 2002/96/EC & 2003/108/EC

  The “Waste Electrical and Electronic Equipment” Directive promotes the recycling of Electrical and Electronic Equipment (EEE) and their components at end-of-life or when being replaced. Environmentally responsible practices are encouraged among all those who are involved in the life cycle of EEE. The WEEE Directive: Mandates a number of recycling procedures …. » more
• Updated on Apr 22, 2009

  REACH 2006 / 1907

  The main aims of REACH are to: Improve the protection of human health and the environment from the risks that can be posed by chemicals Enhance the competitiveness of the EU chemicals industry, a key sector for the economy of the EU Promote alternative methods for the assessment of hazards of …. » more
• Updated on Dec 28, 2008

  Launching Gidos s.p.r.l- Green Regulatory Center

  We are pleased to announce the launching of Gidos s.p.r.l -Green Regulatory Center. Gidos will deal solely with matters pertaining to the compliance with the European Green Directives and Regulations and will be fully operational as of September 1st 2008. . » more
• Updated on Oct 26, 2008

  Medical Device Directive Seminar in Tel Aviv, Israel

  In reference to the expected changes in the European Directives, Obelis initiated a seminar in Tel Aviv at the Israeli Export Institute on June 22nd 2008. The seminar was a great success with over 50 participants in attendance. The seminar focused on guidelines for the first implementations of the RoHS …. » more
• Updated on Oct 26, 2008

  Medical Device Directive Workshop in Sao Paulo, Brazil

  In reference to the expected changes in the European Directives, Obelis and EG Mont Assessoria e Consultoria Ltda. have initiated a workshop in Sao Paulo, Brazil which will focus on these changes and their implications. There are two main changes that are particularly important. A decreasing of the importance of the …. » more
• Updated on Dec 28, 2008

  More About CE Marking

  What is a CE mark? A CE mark is a mark placed on products by their manufacturer that act as a statement that the product meets all the standards and requirements of the relevant legislation according to the appropriate European Directives. CE Marking gives companies easier access into the European market …. » more
• Updated on Aug 19, 2008

  The Latest EU Regulatory Developments

  The new directive 2007/47/EC has implications not only for manufacturers who sell medical devices in the EU but for the medical device industry as a whole. (I)The directive 2007/47/EC amends the following directives: AIMDD 90/385/EEC, MDD 93/42/EEC and the directive 98/8/EC concerning the placing of biocidal products on the market. Manufacturers …. » more