For the 6th year consecutively the European cosmetics Responsible Person Association (ERPA) is organizing the annual Congress on Regulations and Compliance for Cosmetics. Want to know more? Visit our page!
Medical devices and healthcare
A reinforced role for the European Medicines Agency (EMA)
The EU regulators agreed to introduce a new set of tools to improve the EU health security coordination before and during crises by reinforcing the management of disruptions due to the scarcity of medicinal products. Want to know more? Visit our page!
Cobalt in medical devices: French CA publishes a Q&A document
The French competent authority (ANSM) has published information for medical devices containing COBALT. The ANSM informs manufacturers that as of October 1, 2021, cobalt will need to be clasified differently. Want to know more? Visit our page!
MEDICA 2021: Obelis Team Was There!
We met with over 400 manufacturers from more than 50 countries in MEDICA’s halls. Here are the latest news and insights we got from medical manufacturers.
Requirements for Legacy Devices under the MDR as of May 26, 2021
In this article we give you an overview about the MDR requirements that a legacy device must met to be considered compliant.
Use of Octylphenol ethoxylate (Triton-X-100) banned in medical devices and IVDs
The Commission Regulation (EU) 2020/2160 has restricted the use of Octylphenol ethoxylate in Medical Devices and In-Vitro Diagnostic Medical Devices from December 22, 2023, onwards. Want more details? Visit our page!
Legacy Devices and Certificates: Updates from BSI
The BSI announced in June of 2021 updates concerning certificates issued for medical devices. Do you want to know how these changes will affect manufacturers and their industries? Visit Our Website.
French CA issues procedure deal with risks of rupture of essential medical devices and IVDs.
The French CA together with the ANSM has published a management procedure to support the market operators and prevent a shortage of medical devices and in- vitro diagnostic devices.
WEBINAR: EU- SWISS MRA LATEST
Medical device trade is affected by MDR and lack of MRA update. Find out all the details!
Italian authorities confirm: Air purifiers are not medical devices
The Italian Ministry of Health clarified the proper classification of air purifiers and air decontamination systems, as well as their intended use. Find out all the details here!