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The Declaration has two purposes. The first is to provide the recipient (generally the final user or a Notified Body or a Competence Authority) with some information about who was responsible for the CE marking of the medical device, what directive is applied and which standards were applied in order to do this.
The second purpose is to inform about the 'responsible person' and make them consider whether the Directive has been properly followed and the Conformity processes have been completed. The CE marking directives for Medical Devices and IVDs contain duties for the manufacturer which can generally be summarised as follows:
- Ensure the product complies with the essential requirements of the Directive (usually achieved by the application of appropriate standards);
- Where series production is envisaged, ensure that manufacturing controls are in place so as to make sure that all products manufactured are compliant;
- Maintain appropriate technical documentation (Technical file);
- Apply the CE mark to the product and complete the Declaration of Conformity.
Only when all of the above have been properly completed is it legitimate for the product to bear the CE Mark. The person who signs the Declaration should have the knowledge that these things have been done.
The signatory makes a binding commitment on behalf of the Responsible Person that the above processes are properly completed. Normally the director of a company is held liable for any activities of that company, but if the directors can show that they fulfilled their duty to provide good management and adequate resources to their staff, and it was the actions (or inactions) of a junior staff member which caused a breach, the junior staff member will have to answer for their personal actions rather than the Director. Directors have certain specific duties which are why they have to be formally appointed and notified to Companies House, but all members of staff have other legal duties which are appropriate to their position, and just because someone is not a Director does not mean that they cannot be brought before the Courts and asked to account for themselves in the event of the company making a major error in which they were involved.
It's an important point of law that you cannot re-assign your criminal obligations by contract, although you may be able to subcontract the actions which fulfillment of those obligations entails. A company Director has many duties under the law, and most of the actions which those duties require are actually delegated to junior staff. CE marking obligations are just further such duties, which a Director will assign to appropriately qualified staff. However, the duties remain the legal responsibility of the Director and just because he tells someone else to sign the Declaration of Conformity does not mean that he is not liable if the work is not done correctly.
The second purpose is to inform about the 'responsible person' and make them consider whether the Directive has been properly followed and the Conformity processes have been completed. The CE marking directives for Medical Devices and IVDs contain duties for the manufacturer which can generally be summarised as follows:
- Ensure the product complies with the essential requirements of the Directive (usually achieved by the application of appropriate standards);
- Where series production is envisaged, ensure that manufacturing controls are in place so as to make sure that all products manufactured are compliant;
- Maintain appropriate technical documentation (Technical file);
- Apply the CE mark to the product and complete the Declaration of Conformity.
Only when all of the above have been properly completed is it legitimate for the product to bear the CE Mark. The person who signs the Declaration should have the knowledge that these things have been done.
The signatory makes a binding commitment on behalf of the Responsible Person that the above processes are properly completed. Normally the director of a company is held liable for any activities of that company, but if the directors can show that they fulfilled their duty to provide good management and adequate resources to their staff, and it was the actions (or inactions) of a junior staff member which caused a breach, the junior staff member will have to answer for their personal actions rather than the Director. Directors have certain specific duties which are why they have to be formally appointed and notified to Companies House, but all members of staff have other legal duties which are appropriate to their position, and just because someone is not a Director does not mean that they cannot be brought before the Courts and asked to account for themselves in the event of the company making a major error in which they were involved.
It's an important point of law that you cannot re-assign your criminal obligations by contract, although you may be able to subcontract the actions which fulfillment of those obligations entails. A company Director has many duties under the law, and most of the actions which those duties require are actually delegated to junior staff. CE marking obligations are just further such duties, which a Director will assign to appropriately qualified staff. However, the duties remain the legal responsibility of the Director and just because he tells someone else to sign the Declaration of Conformity does not mean that he is not liable if the work is not done correctly.
