Discover what's an adverse health related event, and the new portal for cosmetics.
News
The new South African Health Products Regulatory Authority (SAHPRA)
The South African government has formed an independent, state-owned agency, SAPHRA, to oversee medical device and pharmaceutical regulatory systems.
Certain Eyelash Dyes to be allowed in Cosmetics for Professional Use
The EU Commission has decided to follow the Scientific Committee on Cosmetic Products and Non-Food Products and to allow the use of eyelash dyes in cosmetic products for professional use.
Overview of CE Certification in 2016
Team NB, The European Association of Notified Bodies, released a summary of the Medical Device Sector survey. It gives insight into the number and types of CE and ISO certificates issued or withdrawn for Medical Devices, In-Vitro Diagnostic Devices and Active Implantable Medical Devices in 2016. Team NB assembles 22 European Notified Bodies, such as (among others): TUV, SGS or BSI.
New EU MDR: no grandfathering rule
New European medical device regulation 2017/745 installs new 'no-grandfathering' rule to encourage conformity assessment and compliance throughout EU market.
NEW devices covered by the IVD Regulation
Discover the list and scope of new devices covered by EU in-vitro diagnostics device regulation 2017/746, in effect from April 2017.
Cosmetic claims and labelling under scrutiny
Compliance of claims and labelling of cosmetic products are under scrutiny – according to the recent market reports, there are far too many cosmetic products released on the market that do not comply with the EU legislation on this matter.
The future role of Eudamed
Given new importance by the upcoming EU regulations, the EUDAMED database will provide vital info to industry bodies on medical devices in Europe.
Catalogue of nanomaterials finally published!
The European Commission has published the catalogue of nanomaterials used in cosmetic products, on the market. Find out what this catalogue indicates.
The role of distributors under the new Medical Device Regulation
Learn more about the added roles and responsibilities of medical and in-vitro diagnostic device manufacturers under new EU regulations 2017/745 and 2017/746.