Sara Balzano
Information on Medical Devices Regulation (EU) 2017/745
News about the MDR repealing the Medical Devices Directives 90/385/EEC and 93/42/EEC.
Functional Safety: reference standards
A list of standards to design, integrate and validate safety systems.
Weekly report of RAPEX - Week 21 - 22/05/2020
Here summarised the lighting equipment and the protective equipment reported this week.
Particle filter mask FFP2 - serious risk
Report No 21 published on 22 May 2020, alert number A12/00765/20
Information on Regulation (EU) 2016/425 on personal protective equipment
News about the MDR repealing of the Medical Devices Directives 90/385/EEC and 93/42/EEC.
RAPEX: Flail-type cutting attachments for brush cutter
Report No 20 published on 15 May 2020, alert number A12/00716/20
Information sheets on Radio Equipment Directive 2014/53/EU
The Administrative Co-operation Group (ADC) under the Radio Equipment Directive has made available new information to meet the requirements of the Radio Equipment Directive (RED).
RAPEX: USB charger
Report No 19 published on 8 May 2020, alert number A12/00684/20
Shadows are falling on the e-bikes compliance
The bicycle is an ideal means of transport in the transition from lockdown to normality, when access to public transport is limited to keep distances between people, and the use of private cars will bring traffic and pollution.
Regulatory requirements for ventilators and related accessories
A new guidance on ventilators and related accessories regulated under the Medical Devices Directive 93/42/EEC and on the different options for placing these products on the market.