Learn more about the new European Unique Device Identifier (UDI) classification system and database introduced under EU Medical Device Regulation 2017/745/EC.
Other Industries
Critical ALERT (!) – EU Official Notice on BREXIT
EU Commission issued an official notice to cosmetics product manufacturers in run up to Brexit. Key items include labelling, notification, and information file.
Regulation (EU) 2016/1628 – Pollutant limits in non-road machinery
Find out more about the products and vehicles affected by EU Regulation 2016/1628/EU relating to gaseous and particulate pollutant emission limits in Europe
EU Commission lowers Chromium VI in toy materials
The European Commission's Toy Safety Directive has lowered limits for Chromium VI in scraped-off toy materials (paints, wood, textiles) to 0.052 mg/kg.
Sanitary Certificates for Cosmetics in Italy
Find out more on the controls on cosmetic products entering Italy from third countries.
Team-NB position paper on “Points to add to contracts between Manufacturers and notified bodies”
Team-NB publish template of clauses to be included in contracts between manufacturers and notified bodies, particularly those using older CE certification.
New references of harmonised standards
New references of EU harmonised standards published for personal protective equipment, machinery, ATEX, construction points, pressure equipment, and more.
CAMD and MDR/IVDR transitional provisions
CAMD aim to provide guidance on transitional provisions for manufacturers of medical devices and in-vitro devices under the new EU regulations.
General Data Protection Regulation – scope and main changes
Useful information on the scope and main changes introduced under the new European General Data Protection Regulation, entering into force in May 2018.
Ex-vivo tests: cosmetics without human testing
Find out more information on the European Directive increasing the safety requirements for cosmetic products.