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News and Views March 2017

New Medical Device Regulation (MDR) in Europe

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8. Medical Device Networking Meeting
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In this capacity as “Responsible Person”, MDSS Cosmetics will immediately notify your cosmetic product when the product information file contains all legally required information including safety assessment. Once the notification process is complete, your product will be ready to be placed on the European market and no further approval or notification on national level will be necessary.

The notification of cosmetic products is done via cosmetic product notification portal (CPNP), the central European database for cosmetic products available on the European market. It opened on January 11, 2012 in the course the new European Cosmetics Regulation No. 1223/2009. Since it’s finally entering into force on July 13, 2013 an entry in the database is mandatory for the marketability of cosmetic products.

Beside from the Responsible Persons, the CPNP is only accessible for the competent authorities and to the European poison centres or similar bodies settled in the Member States.

Cosmetic Product Safety Report (CPSR) and Safety Assessment

The safety assessment is the written evaluation part of the Cosmetic Product Safety Report (CPSR) required by the Cosmetic Regulation (EC) No. 1223/2009. The safety assessment is the core element of the Product Information File (PIF). The detailed structure of this document is prescribed in Annex I of the Cosmetics Regulation and shall be conducted only by qualified personnel holding a degree in toxicology or a related discipline, recognized within the European Union. Our team of qualified experts will prepare the safety assessment of your cosmetic product on the basis of provided documentation and established literature, considering raw material and packaging information as well as toxicological, dermatological and microbiological testing results. This summary of documents together with the safety assessment results in the Cosmetic Product Safety Report (CPSR) and serves to certify the safety of the cosmetic product for human health. Should there be the necessity to conduct additional testing of your cosmetic products required for the CPSR, MDSS Cosmetics’ network of partner companies and laboratories will be glad to help you further.