Europe Medical Device Registration

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Most manufacturers would consider Europe as a first target region to penetrate, because of a single approval CE mark certificate(s) which allows penetration to different countries under the European Union.

 

Penetration to other countries in Europe that are not under the European Union may not be difficult since there may be some collaboration agreement between the European Union and those countries.

 

However, do note that for some European Union countries, the Competent Authorities would require product notification and promotion approval in their countries.