The COVID-19 pandemic has provoked a great impact, especially for medical devices, and there has been a much necessary adaptation effort. In this respect, the International Standards Organization (ISO) has announced the elaboration of new standards on Ventilators and Pulse Oximeters.
At the end of 2020, the European Commission (EC) released a Notice regarding the Annual Union Work Programme for European Standardisation for 2021.
Read more about the EDQM report on cosmetics’ compliance with label and claim requirements, in particular the ones concerning allergenic fragrances.
In order to protect the EU citizens’ health and to create a safer Internal Market, the Commission adopted new restrictions under the EU legislation governing chemicals.
Artificial Intelligence (AI) has been used more and more in healthcare. Read our article to learn more about the challenges that manufacturers have to deal
Guidance on Classification Rule for in vitro Diagnostic Medical Devices aims to uniformly apply the classification rules stated in the new regulatory framework
From February 1, 2021, it will be no longer possible to place surgical masks on the Belgian market demonstrating minimum quality following the ATP nor alternative
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.
Data transfer from the EEA to third countries -The finding of an adequate level of protection. The protection of personal data and its interaction with the MDR and IVDR
Following the Digital Healthcare Act (in German, DGV), 73 million insured in the German Statutory Health Insurance can access public healthcare by means of digital health applications (in German, DiGA).