Inspired by the “Qualified Person ” role present in the pharmaceutical field, the concept of Person Responsible for regulatory compliance is one of the changes introduced by the MDR (EU) 2017/745, the new European legislative framework. This change has a significant impact not only on the activity of the Manufacturers of Medical Devices, but also on the Authorized Representatives in the European Union.
However, the presence of the Regulatory Affairs expert within the companies producing Medical Devices is not new. In fact, Manufacturers have often entrusted an internal department (the technical manager or the quality manager) or external consultants with the task of ensuring the conformity of their products with the regulations in force.
The entry into force of the Regulation not only introduces the official recognition of this figure, but it establishes its mandatory presence within the companies operating in this sector. In fact, Article 15 is entirely dedicated to the definition of the requirements, tasks and duties of the Person Responsible for regulatory compliance.
The person in charge with regulatory compliance assumes a role of greater responsibility. In particular, their responsibilities include:
- checking the compliance of the devices with the Quality Management System before they are released;
- verifying that the technical documentation and the EU declaration of conformity are drawn up and updated;
- managing the post-market surveillance obligations and ensuring that they are met;
- managing the reporting obligations and ensuring that they are met.
In an ever-changing field such as that of the MDs and IVDs and considering the soon-to-be-implemented scenario, this role will require even greater specific competence, thus the Management shall take into account a recurring budget to ensure their constant and ongoing training.
The ideal candidate for this role would be a person skilled in multidisciplinary and inter-functional communication, who acts as liaison between the various departments of the company, providing the exchange of information. Furthermore, their role is strategic: they must interface with Management, steering the current and future business strategy, to ensure that the right decisions regarding the manufactured products are taken.
The training of this figure means a greater economic investment of the organization. However, a qualified and competent person will guide the company towards better management and provide an extra guarantee of the product’s safety and effectiveness.
In conclusion, having a highly qualified, competent and up-to-date person who holds the role of the Person Responsible for regulatory compliance can make the difference between remaining on the market of Medical Devices or not.
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Otilia Maya Tanase, PhD
Regulatory Affairs & Marketing Specialist
- European Regulations on Medical Devices (EU) 2017/745
Thema Srl is passionately dedicated to saving lives and preserving the health of men, women, children and animals. Our substantial expertise allows us to be the companies ideal partner for the training of professionals in the sector, ensuring their time and resources optimization.
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