In 2017, Germany has established Nationaler Arbeitskreis (NAKI) - the National Working Group for the Implementation of the new EU Regulations on Medical Devices (MDR) and In Vitro Diagnostics (IVDR). The group was created in order to set up a solid basis for the proper national implementation of new EU
Due to the COVID-19 crisis, production of surgical masks has significantly increased. Therefore, the Belgian Competent Authority FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks. Following the amendment to the ministerial decree of 23 March 2020 laying down specific measures within the framework of
The battle against COVID leads to regulatory changes. The UK, as well as many others, is trying to combat the virus with all its strength and, to do so, needs a non-stop chain of medical devices arriving to its coasts. To this end, the MHRA has accelerated the procedure for
The French National Agency for the Safety of Medicines and Health Products (ANSM) has supported the Directorate-General for Competition, Consumption and the Suppression of Fraud (DGCCRF) in the development of joint recommendations on the affixing of certain claims on cosmetic products. The recommendations focus on claims concerning the absence of
Indigofera tinctoria is a plant known since ancient times for the peculiar properties of its extracts, which can be used both as blue dye for textiles and for cosmetic purposes. Despite its well documented use across centuries, in October 2003 the European Commission requested to evaluate the safety of this
The UK is determined to display full information for users of medical devices, and it is undoubtedly trying to grant them the most effective security as well. To this end, a new reporting site has recently been set up; the Yellow Card reporting site. While being engaged in full-steam negotiations
The COVID-19 global pandemic has severely affected national health systems, which have therefore experienced an unprecedented crisis. Hospitals often had to cope with the fact that purchasing medical devices is not as immediate as it was in the past. The increased worldwide demand and the borders closures have led to
Internet of Things (IoT) has been included as one of the EU’s ICT Standardisation Priorities for Digital Single Market. All “radio equipment”, including its embedded software, as well as all radio products that are part of the IoT, must comply with the Radio Equipment Directive 2014/53/EU (RED)
In the beginning of February 2020, the EU Commission requested the scientific opinion of the Scientific Committee on Consumer Safety (SCCS) regarding the safety of several cosmetic ingredients. The SCCS’s advice enables the Commission to conduct proper risk management and take adequate actions to guarantee consumer protection. Which ingredients
As a response to the current shortages of surgical masks and filtering facepiece respirators, and, especially, in order to meet the needs of the sanitary staff, Belgium has set up a working group on the reuse of these products and issued, alongside other collaborators, a national guideline in the same
On March 12, 2020 the European Commission issued a Corrigendum to its Regulation (EC) No 1223/2009 (Cosmetics Regulation) amendment from November 2019. The update is regarding Salicylic acid, a well-known cosmetic ingredient used for its antidandruff, hair and skin conditioning and keratolytic properties. Salicylic acid – what changed? The Corrigendum
In order to move freely within the Union territory, all in-vitro diagnostic (IVD) devices must be CE marked. The CE Marking serves as a declaration from the manufacturer that their product complies with the essential requirements of the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC). As it might
