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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
Hanover, April 27, 2017



CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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Cosmetics

European Responsible Person Service for Cosmetic Products



Are you a company or a manufacturer of cosmetics products or brand owner outside of the European Union intending to establish / sell products in the European market?

MDSS Cosmetics is the company you are looking for. Our team will be glad to assist you with expertise and over twenty years of experience in European Regulatory Affairs.


At a glance

What can MDSS Cosmetics do for you?

  • As your Responsible Person (RP), MDSS Cosmetics is the officially prescribed legal representative in Europe and the initial point of contact for European authorities.
  • The RP ensures compliance of your cosmetic products marketed within the European Union (EU) under the European Regulation (EC) No. 1223/2009.
  • Carry out the safety assessment and creation of the Cosmetic Product Safety Report (CPSR) for your cosmetic products.
  • Assistance with the Product Information File (PIF)
  • Assistance with the product labeling in accordance with Article 19 of the Cosmetics Regulation
  • Registration of the cosmetic products via the Cosmetic Product Notification Portal (CPNP) prior to placement in the market.
  • Evaluation of provability and credibility of advertising claims and statements used in relation to your cosmetic product according to the Regulation (EC) No. 655/2013.
  • Support in cases of overlap with other law sectors related to your cosmetic product (e.g. REACH, CLP, General Product Safety Directive)
  • Support on reporting serious undesirable effects (SUEs) to the competent authorities (“Cosmetovigilance”)

What does this mean for non-European manufacturers and distributors from outside Europe?
Once MDSS, as your Responsible Person, notifies your cosmetic products via CPNP it is formally classified as marketable and does not require any further official approval or authorization.

What benefits does MDSS Cosmetics provide to your company?
Upon establishing the Product Information File and conducting the notification of your cosmetic products, MDSS Cosmetics will be the initial point of contact for European competent authorities and keeps the Product Information File up to date. By choosing MDSS Cosmetics as your designated Responsible Person and legal representative in Europe your company will avoid unnecessary sharing of confidential information with importers and distributors. You have a one-stop service from a reliable partner on site in Europe who assists you to reach your actual target: Introducing your products onto the European market and to your final customers, who can look forward to enjoy excellent and safe products.


Background

The European Regulation (EC) No. 1223/2009 entered into force in July 2013 and includes an important new key sentence: “Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market” Article 4.1 of the European Cosmetics Regulation (EC) No. 1223/2009


Links

Regulation (EC) No. 1223/2009 (on cosmetic products)
http://eur-lex.europa.eu/legal-content/de/ALL/?uri=CELEX:32009R1223

Regulation (EC) No. 655/2013 (common criteria for claims related to cosmetic products)
http://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32013R0655&qid=1482163814934

CosIng (European Commission database on cosmetic substances and ingredients)
http://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.simple

Ban on animal testing in Europe
https://ec.europa.eu/growth/sectors/cosmetics/animal-testing_de

SCCP opinion on safety of nanomaterials in cosmetic products
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_123.pdf