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Medical Device CE Mark Certificate - Consultancy

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Jassy Sam
Medical Device CE Mark Certificate - Consultancy

Operon strategist don’t leave you before, we make sure that our customer should get the CE approval with minimal efforts. We've a well- experienced staff of expert engineers and significant knowledge and familiarity with the CE marking process. We've a wide knowledge of safety standards, product safety assessments, product design and the real- world issues faced by the manufacturing industries. Our CE Mark Consultant assists new medical device manufacturers to launch a new device into the EU market.


The manufacturer should have CE marking for some product groups for dealing their products in the EEA( European Economic Area), that includes the EU countries and EFTA countries.

 

In case you're an importer, you need to make sure that these products that aren't made in the EEA have CE mark, as it's also obligatory for foreign products to place in the EEA market.

 

The following countries are part of the European Union, CE mark is needed for these countries

  • Austria 
  • Belgium 
  • Bulgaria 
  • Cyprus 
  • Czech Republic 
  • Denmark 
  • Estonia 
  • Finland 
  • France 
  • Germany 
  • Greece 
  • Hungary 
  • Italy 
  • Latvia 
  • Lithuania 
  • Luxembourg 
  • Malta 
  • Netherlands 
  • Poland 
  • Portugal 
  • Republic of Ireland 
  • Romania 
  • Slovakia 
  • Slovenia 
  • Spain 
  • Sweden 
  • United Kingdom

 

The following countries are EFTA countries, CE mark is also needed

 

  • Iceland 
  • Norway 
  • Liechtenstein
  • Switzerland

 

Countries that are part of the CEFTA( Central European Free Trade Agreement), doesn't bear CE marking to vend their products.

 

 The following countries are part of the CEFTA

 

  • Republic of Macedonia Croatia Serbia Montenegro
  • Albania 
  • Moldova 
  • Bosnia 
  • Herzegovina 

 

still, some of the mentioned countries, similar as Republic of Macedonia, Croatia, Serbia, Montenegro, are members of the EU formerly and have adopted the EU legislation.

 

The CE Mark also has Agreements on Mutual Recognition of Conformity Assessment between the European Union and countries similar as the following

 

  • Australia 
  • Canada 
  • Israel 
  • Japan 
  • New Zealand 
  • Turkey


For any medical device regulations regarding information please feel free to contact : [email protected]


Or Visit : https://operonstrategist.com/


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