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June  2009

Impact of Directive 2007/47/EC on future CE Marking audits
Attn: Manufacturers of Medical Devices (excluding IVD) :

  • Is the new definition of MD applicable to your products?
  • Are your products affected by the changes in classification rules?
  • Are the essential requirements updated for your products technical file and particular those related to the assessment clinic?
  • If the classification of products evolves, does it have an impact on your choice of assessment module (annex of the Directive)?

In order to help you answer these questions, the LNE can provide you with a training seminar.

The Directive 2007/47/EC does not define any transitional period. This means that its implementation becomes mandatory on March 21st, 2010; i.e. any medical device (new or pre-existing) placed on the market or put into service after March 21st, 2010 must comply with the updated requirements. In order words, after March 21, 2010, the CE marking is the sign of your commitment to comply with the amended rules.

Concerned manufacturers should take into account these new requirements voluntarily before 21 March 2010 to assure a smooth transition towards their full application of those new rules.

The European Commission issued an interpretative document about the implementation of the directive 2007/47/CE. You can find it on the following link : transitionalperiod_2007-47-EC_guidance_final.pdf.

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