Regulations 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostic Medical Devices introduce the Responsible Person role to grant more authority and importance to the Responsible/Regulatory Officer within the corporate organization.
The role is mistreated: often seen as a “paper shuffler” struggling because it is involved in other functions or contrasts with colleagues as it “hinders” the sale.
Those dealing with regulatory activities were offered a glimmer of hope with this new regulation. A whole article of the New Regulations is indeed dedicated to the Responsible Person role.
The Responsible Person shall present the three following features:
1) a background suited to the position held in the company, that is formal qualifications and experience tailored to the function;
2) complete availability, even in the case of an external consultant;
3) detailed definition of duties and obligations towards the company, such as regulatory and quality control before releasing the product for sale.
The new regulation also requires that the Responsible Person shall preserve a professional dignity as expressed in the paragraph below.
“The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organization.”
It is therefore a fundamental point of the new regulation that the Responsible Person is in a position suitable for the proper performance of his job.
It is well known that the cross-functional relationships of those carrying out regulatory activities in the company are not relaxing at all: in the colleagues (even the Management) eyes it is bit like a Cassandra predicting adverse consequences which eventually come true, or like a Talking Cricket stating an unpleasant lesson.
It is hoped that these official regulation interventions may little by little change the perception of this role by modifying the corporate culture and finally throw light on the strategic significance of this role needed to be able to act effectively and timely on the market (see also http://www.thema-med.com/en/how-to-avoid-the-commercialization-of-medical-devices-strategically/).

Marisa Testa
QA/RA Manager

 

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