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This article summarizes a piece by John Worroll (devices@nsf-dba.com), Consultant at NSF-DBA Medical Devices, part of NSF International’s Health Sciences Division.
The European Commission (EC) proposal for a new regulation to cover medical devices and active implantable medical devices contains a requirement for a Qualified Person (QP). The proposal states that the QP should be responsible for regulatory compliance within a manufacturer’s organization, citing a similar requirement in the EU legislation for medicinal products.
Article 13.1 of the proposal states that manufacturers should have at least one QP who possesses expert knowledge in the field of medical devices. This expertise can be demonstrated with either:
The proposal requires the QP to be within the manufacturer’s organization, which appears to preclude external consultants. However, most manufacturers complying with the medical devices directives already have such a person in their organization. Therefore, providing the experience requirements are met, there may be no need for additional recruitment.
There are two minor derogations for manufacturers of custom-made devices. Firstly, the experience requirement is reduced to two years regardless of academic qualification. Secondly, there is no need for custom manufacturers who are micro-enterprises (as defined by Regulation 2003/361/EC) to have a QP.
The proposal says the QP is responsible for ensuring that the:
In other words, the QP is responsible for ensuring the requirements of the regulation are met by the manufacturer, which is analogous to the ISO 9001 and ISO 13485 requirements for a management representative. In the proposed regulation, the function is to ensure and maintain regulatory compliance, and in the quality management system (QMS) standards, the function is to ensure and maintain the QMS.
Finally, the proposed regulation says that “The qualified person shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his duties.” This mirrors the QMS phrase “irrespective of other responsibilities,” giving QPs freedom to discharge their responsibilities without fear or favor.
Although the role and responsibility of the QP is similar in principle in the pharma and medical device worlds, the differences in detail are significant:
Because of these differences, it has been argued that the term QP should be changed for medical devices to avoid confusion with and “mission creep” toward the pharmaceutical term. On the other hand, medical device manufacturers wishing to comply with the harmonized standard for a quality management system, EN ISO 13485, will note the human resources requirement that “Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.”
Manufacturers may therefore wish to implement a training program to ensure their QPs have both theoretical and practical knowledge of the regulations, rather than just relying on what they have picked up on the job.
The QP requirement should not be onerous as most manufacturers in compliance with the medical devices directives are implementing the requirement already. However, manufacturers may wish to give some thought to a formal training program to ensure they meet not just the letter, but also the spirit, of the requirement and to ensure their compliance with its QMS aspects as set out in EN ISO 13485.
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