The equipment manufacturer shall be able to confirm that the material manufacturer’s quality system certificate meets the requirements of the third paragraph of section 4.3 of Annex I (field of validity of the certification, range of validity of certification, establishment of the competent body as a legal entity within the European Union, accreditation).
The equipment manufacturer should keep track of such information which may be requested by the market surveillance authority. To fulfil this requirement the equipment manufacturer should keep in its technical documentation the appropriate quality system certificate of the material manufacturer or other equally objective evidence.
See also PED Guideline G-02 and PED Guideline G-16.