All radio equipment, including its embedded software, must comply with the Radio Equipment Directive 2014/53/EU (RED). Find out all the details here!
Technology and innovation
EDPS Opinion on clinical research and data protection
Read more about the opinion of the European Data Protection Supervisor holds for the implications of GDPR on clinical research conducted within the EU.
The CPNP Notification Process – Step by step
A simple guide to bringing your cosmetics products though the Cosmetics Products Notification Portal for total European Market compliance.
Obelis new interdepartmental organization
Obelis announces re-organisation of departmental structure in ongoing expansion for greater skill development and improved career path transparency.
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.
Support Point-of-Care Scanning of UDI Data for Implantable Devices: new GS1 guidance
Standards development body GS1 issues implementation guidelines for point-of-care UDI data scanning support for implantable devices across Europe.
Ongoing process for the revision of the Machinery Directive
European Commission's revision of EU Machinery Directive expected in the second quarter of 2021. It's set to clarify definitions of new digital technologies.
New updates on the state-of-the art thinking on UDI system and database.
Learn more about the new European Unique Device Identifier (UDI) classification system and database introduced under EU Medical Device Regulation 2017/745/EC.
Sanitary Certificates for Cosmetics in Italy
Find out more on the controls on cosmetic products entering Italy from third countries.
New references of harmonised standards
New references of EU harmonised standards published for personal protective equipment, machinery, ATEX, construction points, pressure equipment, and more.