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News and Views March 2017

New Medical Device Regulation (MDR) in Europe
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MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
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(+49) -511-6262 8633

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Cosmetics

Responsible Person




“Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market”, says Article 4.1 of the European Cosmetics Regulation No. 1223/2009.


What does that mean for manufacturers, distributors and importers of cosmetic products?

The main obligation of the Responsible Person is to ensure regulatory compliance of the cosmetic product with the established legislation, in particular by maintaining and keeping the product information as required by the Cosmetics Regulation up to date and readily accessible. The Responsible Person is the initial point of contact for the competent authorities and shall, in the case of enquiries, provide relevant information regarding product safety and protection of human health.

Designating MDSS Cosmetics as your Responsible Person takes the load of regulatory obligations from your company and assists you to reach your actual target to introduce your product onto the European market and deliver it to the end-user within the shortest period possible.

Our service portfolio includes, but is not limited to the following:

  • Provision of a valid address within the EU and acting as initial point of contact for the competent authorities in case of regulatory inquiries
  • Notification of your cosmetic product via cosmetic product notification portal (CPNP)
  • Keeping relevant information on the cosmetic product readily accessible within the product information file (PIF)
  • Maintain the product information file for ten years, after the last batch has been removed from the market
  • Providing the safety assessment based on the product documentation and furnished by a formally qualified safety assessor
  • In case of serious undesirable effects immediately reporting the relevant information to the competent authority of the member state where the effect occurred (“Cosmetovigilance”)