Antigen tests are IVDs of class D under the IVDR. This means that they will fall under the highest-risk category of IVDs, needing a Notified Body involvement.
Medical devices and healthcare
EU Circular economy: how to address the problem of increasing electrical and electronic waste
Within the model of the EU circular economy, the economic operators have to comply with the WEEE Directive. Discover all the details in our article!
Obelis Group acquires SYNC Projects Ltd.
In February 2022, Obelis Group acquires SYNC Projects and expands its operations to the Israeli market, securing compliance in a new territory.
New EU Standardisation Strategy: Is the EU a global standard-setter?
The European Commission rolled out a new Standardisation Strategy that will be relevant on a global scale. Visit our page for more information.
What are expert panels for medical devices and IVDs?
The introduction of the new Regulations on medical devices in the European Union meant stricter controls and reinforced rules on transparency and clinical evidence. Learn more!
Shortage of medical and protective equipment: EU strategies to prevent market disruptions
The elimination of barriers and the introduction of free movement of goods, services, and people across the Member States have granted a more dynamic business environment. To learn about the consequences of these new changes visit our page!
Shaping the future of the EU market. The legislative framework for industrial products under revision
In 2008, the European Parliament and the Council jointly adopted the Decision No. 768/2008/EC aiming to set a common framework for a new Industrial Policy. Read more
IVDR: What are EU Reference Laboratories (EURLs)?
With the In Vitro Diagnostic Medical Devices Regulation (IVDR), the IVD sector in the European Union is about to experience significant changes. From a new classification system to stricter assessment procedures and market surveillance. Read the full article to discover all the details!
IVDR: Clinical Evidence Requirements for Manufacturers
Article 56 (1) of the Regulation on in vitro diagnostic medical devices states that manufacturers must specify and justify the level of clinical evidence in view of the characteristics of the device and its intended purpose. Read all the details!
HPRA 2020 Annual Report
Each year, Health Products Regulatory Authority (HPRA) publishes the annual report outlining its activities in the area of public and animals’ health. The Irish agency’s new report was published on November 20, 2021, and summarises last year’s programs development to regulate health products and the safety of cosmetics. Read the full article to know more!