Under EU medical device directive 93/42/EEF, all medical device manufacturers not registered in the EU mush designate an EU Authorized Representative.
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PPE Regulation 2016/425 – end of transition period
As of April 1st, 2019, the transition period for personal protective equipment on the EU market under PPE Regulation 2016/425 has ended.
The French Competent Authorities warns on the use of Phenoxyethanol in leave-on baby products and sets a new labelling requirement!
Agence Nationale de Sécurité de Médicament et des Produits de Santé sets new cosmetic labelling requirement and warns of phenoxyethanol in some EU cosmetics.
What is Eudamed?
Learn more about the new European Databank on Medical Devices and its role in strengthening market surveillance and transparency across the EU.
Bath & Beauty Accessories
Beauty products and devices not directly falling within Cosmetics Regulation 1223/2009 have their own compliance paths based on product's intent of use.
NB-MED Performed a survey on IVDR Readiness of the Notified Bodies
Read more about the results of NB-MED's 2019 survey on the readiness of Notified Bodies for the new In-Vitro Device Regulation in Europe.
Cannabidiol update in CosIng under the EC Cosmetics Regulation 1223/2009/EC
Update on the legal framework and rules for using cannabidiol in cosmetic products on the EU market under EU Cosmetics Regulation 1223/2009/EC.
Soft-filled toys covered with sequins must be safe for children of all ages
European Toy Safety Directive 2009/48/EC states that sequined and soft-filled toys should be safe for children of all ages. Ensure your toys are EU-compliant.
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