MedTech Europe published a statement on the European Strategy for Data. Read about this step forward towards Europe’s digitalized health system here.
Technology and innovation
The upload of software into radio equipment – Commission’s Clarifications
All radio equipment, including its embedded software, must comply with the Radio Equipment Directive 2014/53/EU (RED). Find out all the details here!
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.
National authorities start fining for GDPR breaches
GDPR infringement, GDPR fines, data protection rules
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.
Medical Device Regulation- moving towards a transition
Useful information on the introduction of the European Medical Device Regulation: timelines, strategy, and the Medical Device Coordination Group.
Obelis new interdepartmental organization
Obelis announces re-organisation of departmental structure in ongoing expansion for greater skill development and improved career path transparency.
MDR and IVDR Corrigenda published by the EU
EU announce first corrigenda to medical and in-vitro device regulations. Some make formal changes while others amended content. Learn more with Obelis.
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.