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Person Responsible for Regulatory Compliance
The MDR and the Person Responsible for Regulatory Compliance
On May 26, 2021, Regulation (EU) 745/2017 or MDR came into effect. This European regulation brought numerous changes regarding the legal requirements to be met in the marketing of medical devices (and related products) in Europe, or in other words, in obtaining the CE Marking. Among others, one of the changes or, rather, a requirement that was added was the need for manufacturers of Medical Devices as well as Authorized Representatives to have a figure called Person Responsible for Regulatory Compliance.
Small and medium-sized enterprises can have this figure externally, meaning it does not need to be on the company’s staff, as long as they can demonstrate that it is available whenever needed, or what implies, being able to have it permanently and continuously.
Functions of the Person Responsible for Regulatory Compliance
The Person Responsible for Regulatory Compliance must at a minimum ensure the following:
that before a product is released, its conformity is properly checked through the quality management system used in its manufacture. that the technical documentation and the EU declaration of conformity have been prepared and are up to date. that post-market surveillance obligations are met. that notification obligations are met. And in the case of investigational products, ensure that the manufacturer’s legal compliance affidavit has been made.
As we say, these are the minimum functions to be performed by the Person Responsible for Regulatory Compliance. The company can assign more functions to this person, allowing them to even hold other positions.
The Person Responsible for Regulatory Compliance vs the Technical Responsible
It is important, and we are often asked if this figure is the same as the Technical Responsible (Technical Guarantor), to which we must answer No. Legally they are different figures: while the figure of Technical Responsible is required by the AEMPS (Spanish Agency of Medicines and Medical Devices) competent authority in this matter in Spain, the figure of Person Responsible for Regulatory Compliance is required by Regulation (EU) 745/2017 on medical devices, that is, by Europe.
We could say that the Person Responsible for Regulatory Compliance is in charge of ensuring that all established legal requirements are met before the product is released and during post-marketing, and the Technical Responsible is in charge of ensuring that the product is designed, manufactured, and released meeting all appropriate technical and legal requirements. The latter is a more technical figure, with a more direct relationship with the manufacturing and control of the product before its release.
Qualification of the Person Responsible for Regulatory Compliance
To perform their functions, the Person Responsible for Regulatory Compliance must have certain qualifications and experience:
either has more than four years of professional experience in regulatory affairs or quality management systems related to medical devices, or holds a university degree in Law, Medicine, Pharmacy, Engineering, or another relevant scientific discipline and at least one year of professional experience in regulatory affairs or quality management systems related to medical devices.
For their part, the Technical Responsible must hold a university degree in a discipline related to the product to be manufactured, imported, sterilized, or grouped, such as Engineering, Medicine, Pharmacy, etc. (the university degree will be assessed by AEMPS).
The Person Responsible for Regulatory Compliance and the Authorized Representative
It is sometimes forgotten that not only the manufacturer of medical devices is obliged to have a Person Responsible for Regulatory Compliance. The Authorized Representative must also have this figure. Authorized Representatives are the natural or legal persons (companies) that are MANDATORY for manufacturers not established in the Union, PLAYING a fundamental role in ensuring the conformity of the products they manufacture and serving as a point of contact established in the Union.
They must sign an agreement (mandate, contract…) with their client (manufacturer from outside the Union) in which at least the following functions are established:
Verify that the EU declaration of conformity and the product’s technical documentation have been prepared and that the relevant conformity assessment procedure has been followed (that there is an accredited Notified Body and that the assessment has been carried out correctly). Keep the product’s technical documentation available to the competent authorities (in our case the AEMPS) and whatever is requested. Register the product in EUDAMED. Establish the unique product identification system (UDI).
deviCE Sistemas can provide service for any of these figures and has qualified professionals with proven experience among its staff, allowing them to respond to these functions.
You can request more information by emailing us at efortea@devicesistemas.com.