The Special Committee on Artificial Intelligence in a Digital Age (AIDA), established by the European Parliament, has directed all its efforts in filling current regulatory gaps to develop a European framework on Artificial Intelligence (AIDA, 2021). Read more on the topic here.
Starting from February 15th, 2021, the European Commission launched a call for any interested parties to submit scientific information related to some cosmetic ingredients that may have potential endocrine-disrupting properties. Once the consultation period will be over, the European Commission will request an opinion to the EU Scientific Committee on Consumer Safety (SCCS) on this topic.
The French Competent Authority (ANSM) has prohibited the sale of antibody self-tests based on urine specimen, in view of its inefficacy and non-conformity with the EU requirements.
On January 2021, the Member States unanimously decided to settle a common framework covering the utilization of rapid antigen tests and the mutual recognition of COVID-19 test results within the European Community. Read more about it, here
From January 1, 2021, all EU Trade Marks (EUTM), Registered Community Designs (RCDs) and International Registrations designating will no longer provide protection in the United Kingdom.Read more about it here.
Many changes are occurring on the European continent concerning transport, import and distribution. The main reasons are the consequences of Brexit and the new Medical Device Regulation, that will become fully applicable on the 26th of May 2021.
Swab compliance on Covid-19 IVD Test kits, in order to place this type of tests on the EU market, compliance with the relevant provisions of the Directive is necessary. Read more about it in this article
The end of grace periods for registering your MDD&IVDs and Cosmetics is approaching quickly. Read more about this topic in this article!
On December 16, 2020, the European Commission published the EU’s Cybersecurity Strategy for the Digital Decade.
Read more about the topic in this article.
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.