Guideline I-16
The manufacturer of CE-marked pressure equipment or assembly should be aware that the EU declaration of conformity must be made available for national authorities immediately upon request. Otherwise the presumption of conformity as provided for in Article 5, paragraph 1, is in doubt. For this purpose the manufacturer or his authorised representative established within the […]
Guideline D-12
The document for all quality system modules shall contain sufficient information to clearly define the scope of products covered by the approval and where applicable, any limitations or restrictions. The following list of examples is not exhaustive: In the case of modules D and E the initial quality system approval document shall include a listing […]
Guideline D-15
Yes, Provided that the final assessment has been performed under the QA system certified (and surveyed) by Notified Body “X” before the expiry date of the system certificate. The manufacturer must keep records of which notified body approval his equipment was manufactured under. One solution is to include a date on the declaration of conformity.