At the end of 2020, the European Commission (EC) released a Notice regarding the Annual Union Work Programme for European Standardisation for 2021.
Medical devices and healthcare
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.
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
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
IVDR: MDCG Guidance on classification of in vitro diagnostic devices & proposed symbols for specific IVDs
Guidance on Classification Rule for in vitro Diagnostic Medical Devices aims to uniformly apply the classification rules stated in the new regulatory framework
Rapid Antigen Tests use across Europe: the EU Commission’s Recommendation
Rapid antigen tests are not the most reliable methodology for COVID-19 diagnostic, but they can be a useful tool to face the ongoing pandemic because of their short turnaround times and reduced cost.
Germany becomes the first country in the world to reimburse the prescription of digital health applications
Following the Digital Healthcare Act (in German, DGV), 73 million insured in the German Statutory Health Insurance can access public healthcare by means of digital health applications (in German, DiGA).
Webinar: MDR Compliance for Legacy Devices
In this webinar we provide an overview of Legacy devices, requirements to be respected, EUDAMED Actor Registration
Central traceability system & implant cards mandatory as of May 2021
As of May 1, 2021, notification of the insertion and removal of implantable devices will become mandatory in Belgium for stents, mechanical cardiac and ophthalmological implants, and some other implants