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. More ».
CE Marking
The European Commission describes CE marking as a "Passport to Europe" which allows manufacturers to freely circulate their products within the European market. CE Marking is now mandatory for a wide range of products sold within the European Union... more »
CE - FAQ
What is CE marking?
CE marking means a mark is being placed on products by their manufacturer acting 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 access into the European market to sell their products without adaptation or rechecking...more »
Non-European Manufacturers
If you are a medical device manufacturer located outside the European Union or the European Free Trade Association and wish to export into the European Market, you must follow several steps to ensure that your product is in compliance with the European Directives... more »
Appointing European Authorized Representative
There are many details to consider before appointing your European Authorized
Representative
more »
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.
more »
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.
more »
Featured:
 Obelis is excited to announce the latest OneLink OneSolution advancement. While still retaining the core group of international compliance experts, OneLink OneSolution will begin the process of expanding its boundaries beyond the current service offerings which include regulatory services, language compliance solutions, and new market penetration assistance companies.
OneLink OneSolution will now include businesses from a variety of fields, including marketing, distribution services, public relations, technical writing, and internet marketing. These companies will be carefully selected to ensure they maintain the same superior standard as current OneLink OneSolution members ....
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O.E.A.R.C.Medical Device Exhibition Participation
Obelis European Authorized Representative is proud to announce its participation in the worlds most important medical device exhibitions
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Obelis 20th Anniversary
It is with great pleasure that we announce the 20th Anniversary of Obelis s.a. Read more
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 Read more
(EC) REACH 2006/1907
REACH is the regulation for Registration, Evaluation, Authorization (and Restriction) of Chemicals. The regulation places greater responsibility on the industry to manage the risks chemicals may pose to health and the environment. Read more
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.
Read more
RoHS 2002/95/EC
The Restriction of the use of certain Hazardous Substances specifies maximum levels for use of 6 restricted hazardous substances in the
manufacture of various types of Electrical and Electronic Equipment (EEE). RoHS coincides with the WEEE Directive as part of a legislative
initiative to solve the problems and risks associated with large amounts of electric waste. Read more
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. Read more
CD of Essential Requirements for MDD & MSD
As a foundation for the implementation of the expected amendments within European Directives, Obelis has created a CD containing valuable information which will assist in the implementation of these Directives. read more »
Italy Registration
Placing your product into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). read more »
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