On May 26, 2021, the Medical Devices Regulation 2017/745 entered into application. This brought many implications for medical devices manufacturers, regardless of the class. We have previously covered MDR topics, such as how to achieve compliance for Class I medical devices and we will now address the requirements for
On September 28, 2021, the European Commission launched the first meeting of the HLCF (High-level construction forum). More than two hundred representatives from the EU member states, stakeholders, social partners, and the European Commission took part in the exchange, addressing the HLCF’s main prerogatives. 1. The HCLF Aim The
On September 16, the European Parliament adopted a Resolution calling for an EU-wide action plan to phase out the use of animals in research and testing. While acknowledging the advances animal testing has had in developing treatments for human and animal health in the past, the Parliament underlines several shortcomings
Innovation and rapid development are certainly two of the objectives that the European Union is trying to promote, together with the proposition of sustainable solutions to safeguard the future of the environment. For this reason, the European Commission is working on a proposal for amending the Radio Equipment Directive 2014/
Due to the COVID crisis, Commission Regulation (EU) 2020/2160 of 18 December 2020 extended the permission of using Octylphenol ethoxylate (Triton-X-100) in medical devices, in-vitro diagnostic medical devices and their accessories for the diagnosis, treatment or prevention of COVID-19. However, its use will become restricted on December 22, 2023.
BSI announced in June 2021 updates concerning certificates issued for medical devices covered by Article 120 of the Medical Devices Regulation (MDR) 2017/745 (legacy devices). The updates concern two topics: 1. Changes reported by manufacturers to the Notified Body According to MDR Article 120 (3), medical devices covered by
The French National Agency of Medicines and Health Products Security (ANSM) has recently published a special management procedure for market operators to prevent a shortage of medical devices and in-vitro diagnostic devices. As France does not currently have a legal framework deal with the issue, the new management framework gives
On June 30, 2020 IFRA officially issued the 50th Amendment to the IFRA Standards. This amendment comes in addition to previous Amendments to the IFRA Code of Practice. Consequently, all elements of the 49th Amendment - dated January 10, 2020 - addressing other fragrance materials, remain unchanged and in place.
On June 11, 2021, the Italian Ministry of Health published an open letter to address the classification issue of air purifiers and air decontamination units. It was clarified that these products do not have a medical intended purpose, as they do not directly operate on patients – they are instead used
The Spanish Agency of Medicines and Medical Devices (AEMPS), together with the National Association of Perfumery and Cosmetics in Spain (STANPA), has published a guide on manufacturing of safe raw materials and cosmetic products in terms of microbiological and conservation characteristics. The AEMPS promotes scientific knowledge guaranteeing safe cosmetic products.
On June 3, 2021, there were two updates concerning the Toy Safety Directive: the first concerns an amendment from the European Commission that limits aniline as a dangerous substance in toys; the other is SCHEER’s new opinion, the Toxicological reference values for certain organic chemicals emitted from squishy toys
As an extra option for users in Belgium, the Belgian Federal Agency of Medicines and Health Products (AFMPS) has decided to allow antigens self-tests to be sold out of pharmacies. Through the amending decree of June 24, 2021, COVID-19 antigen self-tests can be sold freely as of the July 1,
