Norway Medical device Companies

BD - Australia/New Zealand

Updated 05/2011

Thanks to the single market, today EU companies can sell and buy goods throughout the Union.

Free movement of goods

The EU has ended difficult obstacles before imports and exports: now companies are free to transport and sell goods throughout the Union.

Restrictions

EU countries may restrict the free movement of goods in exceptional cases and for reasons of public interest such as public health and safety, environmental protection or consumer welfare. The restrictions must be proportionate.

The free movement of goods can also be restricted as a precautionary measure if objective data indicating that poses a threat to people, animals, plants or the environment.

New Legislative Framework

To eliminate the remaining obstacles to the free movement of goods, the EU has adopted new rules that establish:

  • stricter application of EU rules on the single market
  • better rules on market surveillance
  • a common framework on product marketing
  • credibility for CE marking
  • the full implementation of mutual recognition.
  • New Legislative Framework

Harmonization

The differences between national technical regulations may hinder trade. Hence, the EU has harmonized the rules governing a number of products, especially those considered high risk: pharmaceuticals, vehicles, toys, chemicals, electrical and mechanical equipment and medical devices. The products manufactured under these rules may be traded on the market of any member.

Since the mid-eighties, the EU has developed a new approach to technical harmonization based on standardization.

European standards, the new approach directives calls - place the essential requirements to be met by the goods to be sold across the EU. Manufacturers must convert these essential requirements into technical specifications.

To help some 20, 000 have been published European standards. The products complying to be compliant with EU directives. But the rules are not mandatory: Manufacturers may choose other technical solutions to meet the requirements.


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2013-03-20 12:19:34 by flaveur

"Obamacare" ..jobs destroyed in NY, WI, MA, etc.

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

2013-03-20 12:20:55 by flaveur

Um, it's actual closings and layoffs. Hello?

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

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