Exporting to the European Union
If you are intending to export goods into Europe you should be aware that there are European laws to be negotiated. Add to this that not all European state laws are the same!
First off the mark is CE marking, more on that in a minute ....
For Medical devices there are even more hurdles to climb, not least the regulatory requirements.
In essence you need to establish the risk level of your goods - This is the potential risk, not necessarily the actual risk and not confined to when your product is working as expected. There is documented technical files to compile, and a variety of other regulatory requirements. You will also need to establish that your product is indeed a medical device!
Finally, will you need a certified quality management system?; Which directive governs your product and which harmonized standards are to be applied?
Oh, don't forget that there may be language translation requirements.
To find some of the answers click on the "CE" buttons above including the "Technical file"
AQAS will make it happen for you. Simply e-mail sales@aqas.com.au
Where or what is the European Market?
The European Union (EU) is a union of twenty-five independent states
based on the European Communities and founded to enhance political,
economic and social co-operation. Formerly known as the European
Community (EC) or European Economic Community (EEC).
The date of foundation: 1st November, 1993.
Member states:
EU Member States as of 01.05.04
Country Official Language Additional Languages
Austria German
Belgium French Dutch, German
Britain English
Cyprus Greek
Turkish, English
Czech Republic Czech
Denmark Danish
English, Faroese, Greenlandic
Estonia Estonian Russian, Ukrainian, Finnish
Finland Finnish Swedish
France French
Germany German
Greece Greek
Hungary Hungarian
Ireland English
Italy
Italian
Latvia
Latvian Lithuanian, Russian
Lithuania Lithuanian Polish, Russian
Luxembourg
French German
Malta Maltese English
Netherlands Dutch Frisian
Poland Polish
Portugal Portuguese Mirandese
Slovakia Slovakian
Hungarian
Slovenia
Slovenian Serbo-Croatian
Spain
Spanish
Sweden
Swedish
EU Languages
Danish, Dutch, English, Finnish, French, German, Greek, Italian,
Portuguese, Spanish, Swedish, Czech, Estonian, Hungarian, Latvian,
Lithuanian, Maltese, Polish, Slovakian and Slovene.
Iceland, Liechtenstein, and Norway are EFTA countries
Medical device design and manufacturing organizations need to ensure
compliance to the related directives. One such directive is the Medical
Device Directive or MDD. AQAS can provide assistance in this regards.
E-mail: sales@aqas.com.au