Guideline G-29
No, unless in exceptional circumstances, as outlined below: The extent of additional testing shall be specified by the equipment manufacturer and it should be at least equivalent to the tests specified in the harmonized standard, if available, for a similar type of material and representative of the entire batch of the material used for the […]
Guideline F-02
In addition to the documents required in the conformity assessment module, the following documents should be available as applicable: These documents shall be available for final inspection whether that inspection is carried out by the manufacturer, the user inspectorate or the notified body.
Guideline D-07
Yes. PED requires the manufacturer to prepare operating instructions (see Annex I section 3.4) and supply them together with the equipment. Appropriate operating instructions are an essential safety requirement (ESR) and shall therefore be part of the conformity assessment procedure. When the Notified Body’s duty includes performing or monitoring final assessment, it shall verify the […]
Guideline D-13
No. In modules F and G, means and resources for carrying out the final inspection and/or proof test can be provided by the manufacturer to the Notified Body inspector, but the Notified Body shall be present during the final inspection and proof test.