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
News
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.
ECJ delivers a judgment on a Defeat device on diesel engine
The Court of Justice of the European Union released a Judgement regarding the placing on the market of defeat devices on diesel engines. Read more about it here.
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.
Toy safety: the EU moves to protect children from potentially allergenic fragrances in toys
On December 11, 2020 the EU Commission adopted two Directives – 2020/2088 and 2020/2089 – to amend the Annex II to the Toy Safety Directive (2009/48/EC).
Rapid Antigen Tests use across Europe: Council of the European Union’s Recommendation
Council of the European Union adopted on a Recommendation on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the EU
New marking specifications for single-use plastic products -impact on cosmetic industry-
The impact of The Single-Use Plastic Directive (EU) 2019/904 on the cosmetic industry. Learn more about it in this article.