RESPONSIBILITY FOR PREPARING THE DECLARATION OF CONFORMITY. The product owner of the medical device or a person authorised by the product owner is responsible for preparing and signing the DOC. The hardcopy of the DOC should be signed and dated. The signed and dated hardcopy should be part of product registration. The original signed copy of the DOC should be made available to the regulatory authority of a Member 2 Standards may include international (e.g. ISO, IEC), regional (e.g. CEN) and national (e.g. SS, ASTM, BS) standards. State upon request. A Member State may impose additional measures (e.g. legalisation or notarisation) to be undertaken to ensure the authenticity of a DOC submitted to the regulatory authority of that Member State.
RESPONSIBILITY FOR PREPARING THE DECLARATION OF CONFORMITY. The product owner or physical manufacturer of the medical device is responsible for preparing and signing the DOC. A copy of the signed and dated DOC should be submitted as part of product registration. The original signed copy of the DOC should be made available to the Regulatory Authority 1 Standards may include international (e.g. ISO, IEC), regional (e.g. CEN) and national (e.g. SS, ASTM, BS) standards. of a Member State upon request. A Member State may impose additional measures (e.g. legalisation or notarisation) to be undertaken to ensure the authenticity of a DOC submitted to the Regulatory Authority of that Member State.
