Due to the medical nature of the devices, incidents are bound to happen sooner or later. It is therefore crucial for any manufacturer to know how to react!
Did you know? It is a legal obligation to report incidents to the Competent Authorities and to maintain a Medical Devices Post Market Surveillance System!
European Commission’s European Green Deal aims at transforming production and consumption of products on the EU market, in order for them to become more durable, resilient and eco-friendly.
Rapid antigen tests are not the most reliable methodology for COVID-19 diagnostic, but they can be a useful tool to face the ongoing pandemic because of their short turnaround times and reduced cost.
Cosmetics Europe published the updated version of the Charter and Guiding Principles on Responsible Marketing Communications to ensure better consumer protection in the new digitalized world.
In this webinar, we will be addressing the new Regulation on Market Surveillance & Compliance of Products to assist online sellers in their compliance path:
In this webinar we provide an overview of Legacy devices, requirements to be respected, EUDAMED Actor Registration
Through this interview, you will get more insight about Obelis. What are doing and how can we help you to compliance with EU regulations.
Regulatory Framework & National Registrations information for manufacturers who want to place their products in the EU market.
Cannabis and its related components pose specific challenges to compliance with the Cosmetics Regulation 1223/2009/EC, main regulatory framework for cosmetics
It is crucial to remember the importance of Regulation (EU) No 655/2013, regulating the common criteria for the justification of claims on cosmetic products.