Regulatory Open Forum

Hi all,

I've noticed that our self-declaration process for compliance of non-medical electric instruments with electrical safety CE marking and RoHS, involves DoC and Technical document (or technical documentation). However, I'm uncertain about the scope of the technical document required.   

Does the term "Technical Document" refer to a comprehensive collection of documents that verify the electrical safety of the equipment (such as test reports and certification for electrical, radio, magnetic, EMC .... safety?)

Or does the 'Technical Document" pertain to a single document that consolidates all relevant test reports, certifications, and safety assessments?

Thanks for your collaboration

Hello Anon,

In general, the "Technical Document" is a collection of the documents showing and supporting through evidence how the compliance is met against a Directive or Regulation.  It does not necessarily need to be a single document with all consolidated documents, though really depends on who might be asking for the documents and how they are provided.  Myself, I generally create a Technical Document "index" which is a singular document with summary of all of the testing reports, which then there is a reference to each of the individual testing reports.  Then depending on who needs the document or how provided, the files can be organised accordingly.

Hi all,

I've noticed that our self-declaration process for compliance of non-medical electric instruments with electrical safety CE marking and RoHS, involves DoC and Technical document (or technical documentation). However, I'm uncertain about the scope of the technical document required.   

Does the term "Technical Document" refer to a comprehensive collection of documents that verify the electrical safety of the equipment (such as test reports and certification for electrical, radio, magnetic, EMC .... safety?)

Or does the 'Technical Document" pertain to a single document that consolidates all relevant test reports, certifications, and safety assessments?

Thanks for your collaboration

Thank you for clarifying!

Could you please share how your company allocates the responsibilities for generating and maintaining the DoCs and Technical files between the Quality and Regulatory teams.

What roles do each team play? 

Hello Anon,

In general, the "Technical Document" is a collection of the documents showing and supporting through evidence how the compliance is met against a Directive or Regulation.  It does not necessarily need to be a single document with all consolidated documents, though really depends on who might be asking for the documents and how they are provided.  Myself, I generally create a Technical Document "index" which is a singular document with summary of all of the testing reports, which then there is a reference to each of the individual testing reports.  Then depending on who needs the document or how provided, the files can be organised accordingly.

Hi all,

I've noticed that our self-declaration process for compliance of non-medical electric instruments with electrical safety CE marking and RoHS, involves DoC and Technical document (or technical documentation). However, I'm uncertain about the scope of the technical document required.   

Does the term "Technical Document" refer to a comprehensive collection of documents that verify the electrical safety of the equipment (such as test reports and certification for electrical, radio, magnetic, EMC .... safety?)

Or does the 'Technical Document" pertain to a single document that consolidates all relevant test reports, certifications, and safety assessments?

Thanks for your collaboration

Hi all,

I've noticed that our self-declaration process for compliance of non-medical electric instruments with electrical safety CE marking and RoHS, involves DoC and Technical document (or technical documentation). However, I'm uncertain about the scope of the technical document required.   

Does the term "Technical Document" refer to a comprehensive collection of documents that verify the electrical safety of the equipment (such as test reports and certification for electrical, radio, magnetic, EMC .... safety?)

Or does the 'Technical Document" pertain to a single document that consolidates all relevant test reports, certifications, and safety assessments?

Thanks for your collaboration

Hi all,

I've noticed that our self-declaration process for compliance of non-medical electric instruments with electrical safety CE marking and RoHS, involves DoC and Technical document (or technical documentation). However, I'm uncertain about the scope of the technical document required.   

Does the term "Technical Document" refer to a comprehensive collection of documents that verify the electrical safety of the equipment (such as test reports and certification for electrical, radio, magnetic, EMC .... safety?)

Or does the 'Technical Document" pertain to a single document that consolidates all relevant test reports, certifications, and safety assessments?

Thanks for your collaboration

Hi all,

I've noticed that our self-declaration process for compliance of non-medical electric instruments with electrical safety CE marking and RoHS, involves DoC and Technical document (or technical documentation). However, I'm uncertain about the scope of the technical document required.   

Does the term "Technical Document" refer to a comprehensive collection of documents that verify the electrical safety of the equipment (such as test reports and certification for electrical, radio, magnetic, EMC .... safety?)

Or does the 'Technical Document" pertain to a single document that consolidates all relevant test reports, certifications, and safety assessments?

Thanks for your collaboration

Hi all,

I've noticed that our self-declaration process for compliance of non-medical electric instruments with electrical safety CE marking and RoHS, involves DoC and Technical document (or technical documentation). However, I'm uncertain about the scope of the technical document required.   

Does the term "Technical Document" refer to a comprehensive collection of documents that verify the electrical safety of the equipment (such as test reports and certification for electrical, radio, magnetic, EMC .... safety?)

Or does the 'Technical Document" pertain to a single document that consolidates all relevant test reports, certifications, and safety assessments?

Thanks for your collaboration

Hi all,

I've noticed that our self-declaration process for compliance of non-medical electric instruments with electrical safety CE marking and RoHS, involves DoC and Technical document (or technical documentation). However, I'm uncertain about the scope of the technical document required.   

Does the term "Technical Document" refer to a comprehensive collection of documents that verify the electrical safety of the equipment (such as test reports and certification for electrical, radio, magnetic, EMC .... safety?)

Or does the 'Technical Document" pertain to a single document that consolidates all relevant test reports, certifications, and safety assessments?

Thanks for your collaboration