From April 4, 2021, rapid antigen self-tests are allowed for sales in Belgian pharmacies! However, only if they respect strict conditions set out and verified by the Belgian Competent Authority FAMHP. Read more about it here!
News
The European privacy family & UK: towards an adequate level of personal data protection
The first step for the adoption of the adequacy decisions for transfers of personal data from the EU to the United Kingdom has been taken: the European Commission has published two draft decisions, one under the General Data Protection Regulation (GDPR) and the second one under the Law Enforcement Directive (LED).
Webinar: Software classification & compliance and MDR review process
In the webinar we provide an overview of MDR review process for Software, MDR Class I software, MDD Class I Software with class upgrade under MDR and more
COVID-19: France bans urine self-tests and opens the possibility for antigen self-tests
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.
European preparedness and response to the COVID-19: a common list of rapid antigen tests
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
EU Intellectual Property rights – are we covered in the UK?
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.
Logistical barriers due to Brexit and MDR
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.
Covid-19 IVD Test Kits – Swab Compliance
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 UK Market Post Brexit: End of Grace Periods Approaches
The end of grace periods for registering your MDD&IVDs and Cosmetics is approaching quickly. Read more about this topic in this article!
New EU Cybersecurity Strategy and new rules to make physical and digital critical entities more resilient
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.