Every year, the EPAA publishes a report about what has been done in the field of the 3Rs: Replacement, Reduction and Refinement of animal testing. Despite the odds, 2020 was no exception and the new report presents especially important news as the EPAA prepared the new Action Programme for the
On November 13, 2020, the Medical Device Coordination Group (MDCG) published a Guidance on Classification Rule for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 with the aim to help manufacturers, Competent Authorities, notified bodies and stakeholders to uniformly apply the classification rules stated in the new regulatory
The Belgian Competent Authority concluded that the situation on the market has improved, and the exceptional measures, based on the European Commission Recommendation 2020/403, are no longer needed when it comes to surgical masks. From February 1, 2021, it will be no longer possible to place surgical masks on
The European Parliament’s (EP) own-initiative Report Towards a more sustainable single market for business and consumers (2020), based on the European Commission’s European Green Deal aims at transforming production and consumption of products on the EU market, in order for them to become more durable, resilient and eco-friendly.
ANSES, French Agency for Food, Environmental and Occupational Health & Safety, brings off an unprecedented assessment of the types and composition of tobacco and vaping products sold on the French market under the new European regulatory framework. The overview tracks down inconsistencies and non-conformities in the data reported by the
On November 18, 2020, the European Commission (EC) published a Recommendation on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection. This was necessary because the number of SARS-CoV-2 infections continues to rise, and consequently, tests demand increases as well: as a result, Member States’ health systems
On September 15, 2020, Cosmetics Europe published the updated version of the Charter and Guiding Principles on Responsible Marketing Communications, in order to ensure better consumer protection in the new digitalized world. We are all aware of the increasing importance of digital advertising, and of the more and more popular
Following the Digital Healthcare Act (in German, DGV), promulgated on December 19, 2019, 73 million insured in the German Statutory Health Insurance can access public healthcare by means of digital health applications (in German, DiGA). The costs associated with the use of such applications will be reimbursed by Statutory Health
We have recently sat down with Gideon Elkayam, Founder & CEO at Obelis Group, to reflect on the results of the past year and the achievements of the company. We've had the pleasure to hear from him some personal insights and stories that are part of the history of the
On May 12, 2020, the Chinese government has published a new safety standard for batteries of electric vehicles, the GB 38031-2020 standard. It will come into effect on January 1, 2021 and shall be used from that date on. This Standard specifies safety requirements and test methods for power battery
On October 5, 2020, the Scientific Committee on Consumer Safety (SCCS) published the Scientific Advice on the safety of nanomaterials in cosmetics, shedding some light on this rather obscure aspect of the cosmetic industry. Why obscure? As the SCCS identifies, because of the novelty of the practice of incorporating nanomaterials
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, as well as some other implants included in Annex to the Royal Decree, while the list of devices might be extended. The Central Traceability
