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
Medical devices and healthcare auto
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.
New ISO standard available for COVID Ventilator
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.
European standardisation for 2021. An overview of relevant objectives and policies.
At the end of 2020, the European Commission (EC) released a Notice regarding the Annual Union Work Programme for European Standardisation for 2021.
Allergenic fragrances in cosmetics sold as “perfume-free”: the EDQM report
Read more about the EDQM report on cosmetics’ compliance with label and claim requirements, in particular the ones concerning allergenic fragrances.
Regulating Toxic Chemicals: Safer Tattooing Inks and Permanent Makeup for a Safer EU Market
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.
How MDR regulates software?
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