Find out some key characteristics for the new ISO Standard on labelling for medical devices. What does the new ISO 20417:2021 change? Read more here.
Medical devices and healthcare auto
Medical Device Regulation and Artificial Intelligence: what future requirements?
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.
Call for data on ingredients with potential endocrine-disrupting properties used in cosmetic products
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.
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
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.