Person responsible for regulatory compliance - medical devices

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The 745/2017 Regulation on Medical Devices introduces the figure of the Person Responsible (PR), with the aim of giving this figure greater authority and importance to the Responsible / Regulatory Officer within the medical device company organization.

The new Regulation dedicated a whole article to the figure of the Person Responsible and according to it, there are some main characteristics that the Person Responsible for regulatory compliance must have:

background suited to the position held in the company, ie a degree of study and experience appropriate to the function. This means having a diploma, certificate or other qualification obtained for completing university studies in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in the field of regulation or quality management systems related to medical devices;
work organization and analytical skills of complex problems;
transparency and credibility;
rigor and seriousness;
total availability, even if it is an external consultant;
detailed definition of tasks and obligations towards the company, such as regulatory and quality control before the release of the product.

The new regulation also requires that the Person Responsible (PR) has a professional dignity.

The Person Responsible guarantees, in compliance with standards, the supervision and control of the manufacture of medical devices, as well as the post-marketing surveillance and surveillance activities relating thereto. He/ she has the task of ensuring at least that:

the compliance of the devices is adequately controlled in accordance with the quality management system under which the devices are manufactured, before a product is released;
the technical documentation and the declaration of conformity are drafted and updated;
the post-marketing surveillance obligations according to the relevant articles are met;
the obligations to report incidents are met;
in the case of devices intended for clinical trials or involving risks for the subjects of the studies, the expected declaration is issued.

These official interventions by the New Regulation can gradually change the perception of the role of the Responsible Person, modifying the culture of companies producing medical devices, and can point out the strategic significance of this figure necessary to make the companies able to act effectively and promptly on the market of medical devices.

If a person has the minimum requirements mentioned above, one of the available paths to a formal recognition of professional profile is being certified by an independent third-party Organization (for example, in Italy, AICQ - SICEV).

Subsequently, the creation of a Professional Profile Registry as a voluntary certification can give proof of continuous compliance and active update of professional skills.

Alice Ravizza, Biomedical Engineer