News

National MDR implementation – Germany’s establishment of NAKI

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

MHRA regulatory flexibilities resulting from coronavirus (COVID-19)

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

Indigofera tinctoria as hair dye ingredient: is it safe?

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

UK’s new dedicated Yellow Card reporting site

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 upload of software into radio equipment – Commission’s Clarifications

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)

Request for scientific opinions of SCCS: certain ingredients under review

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

New restrictions for Salicylic acid

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