Sara Balzano
RAPEX: LED party light and speaker (fixed luminaire) - serious risk
Report No 15 published on 10 April 2020, alert number A12/00563/20
Regulation (EU) 2017/745 posponed by one year
Date of application of Regulation (EU) 2017/745 on medical devices postponed by one year
RAPEX: Fireworks Megatresk Explo - serious alert
Report No 14 published on 3 April 2020, alert number A12/00506/20
RAPEX: Work gloves - serious alert
Report No 13 published on 27 March 2020, alert number A12/00478/20
COVID-19: conformity assessment and market surveillance procedures
The COVID-19 pandemic and the rapid spread of the virus in Europa has greatly increased the need for personal protective equipment (PPE) such as masks, gloves, protective suits or goggles and medical devices such as surgical masks, examination gloves and certain types of gowns.
Inform users of the residual risks
The operating instructions are essential for the machine as they provide the user with the information necessary to operate the machine in safety conditions.
What are the minimum requirements for the content of the instructions for use?
The list of minimum contents of the instructions for use given in Directive 2006/42/EC is not exhaustive. The manufacturer of the machinery should also provide other information that may be necessary. The Machinery Directive states in requirement 1.7.4.2 that " each instruction manual must contain, where applicable, at least the following information ...".
CE marking: a guarantee of a safe machine
Some notes on CE marking
New Legal Framework (NLF)
What are the legal acts composing the New Legal Framework?
Let's find out!
How to write instructions for use of products
What standards are available to write instructions for use manuals?