The new factsheet published by the European Commission shows the necessary steps for compliance. Find out how to achieve MDR compliance in 9 steps.
Consumer goods
European Commission Guidance on Free Movement of Goods
What do the guidance documents on the free movement of goods from the European Commission state?
Find here more information on the three documents.
COVID self-tests in Belgium: Conditions and approval process
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!
WEBINAR: The two-step compliance program for online sellers
In this webinar, we will be addressing the new Regulation on market surveillance & compliance of products to assist online sellers.
Webinar: Post Market Activities under MDR
Due to the medical nature of the devices, incidents are bound to happen sooner or later. It is therefore crucial for any manufacturer to know how to react!
Did you know? It is a legal obligation to report incidents to the Competent Authorities and to maintain a Medical Devices Post Market Surveillance System!
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.
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.
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).
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.