On October 29, 2021, the European Commission adopted a delegated act to the Radio Equipment Directive aiming at scaling up the cybersecurity of wireless devices and products for the benefit of consumers. Want to know more? Visit our page!
News
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.
European Commission launches the High Level Construction Forum
On September 28, 2021, the European Commission launched the first meeting of High- Level construction forum! The main goal is to establish a new construction ecosystem; digitalized and under the green policy.
European Parliament calls for action plan to phase out animal testing
On September 16, the European Parliament adopted a Resolution calling for an EU-wide action plan to phase out the use of animals in research and testing. Want to know more? Visit our page!
The advantages of a common charger for the EU market
The European Commission is working on a proposal featuring the idea of a common charger for several types of technological devices. Want to know more? Visit our page!
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!
WEBINAR: UK SCPN COSMETIC PRODUCT REGISTRATION
In this webinar, we will provide an overview of the role of the Responsible Person in UK and the notification process