Report No 15 published on 10 April 2020, alert number A12/00563/20

Date of application of Regulation (EU) 2017/745 on medical devices postponed by one year

Report No 14 published on 3 April 2020, alert number A12/00506/20

Report No 13 published on 27 March 2020, alert number  A12/00478/20

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.

The operating instructions are essential for the machine as they provide the user with the information necessary to operate the machine in safety conditions.

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 ...".

Some notes on CE marking

What are the legal acts composing the New Legal Framework?

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What standards are available to write instructions for use manuals?