The Person Responsible for Regulatory Compliance (PRRC) is one of the most critical elements of MDR (EU) 2017/745 as the responsibilities of the PRRC impact on product documentation, system documentation and, more generally, on the entire organization of the Manufacturer or Authorized Representative.
Necessary skills and minimum requirements: how to identify the PRRC
Article 15 of the MDR defines the competences and minimum requirements for the role of Compliance Officer.
The minimum requirements are evidenced by the PRRC candidate’s compliance with the following qualifications:
- a diploma, certificate or other qualification obtained by having completed university studies or a course of study recognised as equivalent by the Member State in question, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year‘s professional experience in the field of regulation or quality management systems for Medical Devices; alternatively
- four years of professional experience in the field of QA/RA, regulation or quality management systems related to Medical Devices, if he/she does not hold a degree in the relevant scientific field.
For manufacturers of custom-made devices, experience in device production activities must be at least two years.
Internal or external PRRC
Manufacturers within their organisation shall have at least one Responsible Person who possesses the necessary skills and minimum requirements in the field of Medical Devices.
Organisations may only appoint an external PRRC only if they fall into the category of micro or small enterprises and subcontract their responsibilities to a third party through a Quality Technical Agreement (QTA).
Even if the PRRC is external to the organisation, it must fulfil the characteristics of:
- continuity of service > the PRRC must be permanently and continuously available;
- availability > the PRRC must respond promptly in the event of urgent activities to be performed within the timeframe required by the regulation;
- interaction with the organisation > the PRRC must be integrated into the organisation’s processes.
For micro or small organisations and start-ups, conflicts of interest may arise in the allocation of PRRC responsibilities to the Quality Assurance and/or Legal Representative precisely because of the limited number of people involved.
There are 3 possible conflict of interest scenarios. Find out which ones!
- The Responsible Person coincides with the QA/RA (or Quality Assurance) Manager > for this situation there are no particular conflict of interest problems. As a matter of fact, Quality Assurance is on the staff of the Management, as the PRRC is recommended to be, and the competences of the former are a natural substratum for the latter.
- The Responsible Person coincides with the Legal Representative > this situation is potentially a harbinger of a conflict of interest and is only manageable if the Quality Assurance is another person who supervises, also by means of audits, the potential non-objectivity and impartiality of the roles;
- The Responsible Person coincides with the QA/RA (or Quality Assurance) Manager and coincides with the Legal Representative > this scenario is contestable as it creates a possible conflict of interest.
Responsibilities of the PRRC
The PRRC is at least responsible for ensuring that:
- the conformity of devices is adequately checked in accordance with the quality management system under which the devices are manufactured before a device is released;
- the technical documentation and the EU declaration of conformity are drawn up and up-to-date;
- the post-market surveillance obligations set out in Article 10(10) (obligations of manufacturers) are fulfilled;
- the reporting obligations set out in Articles 87 to 91 (supervision)
- in the case of devices under investigation, the declaration referred to in Annex XV, Chapter II, point 4.1 is issued.
Regardless of the above, which constitutes the minimum content of the responsibility portfolio, the horizontal extension or vertical incisiveness of the PRRC’s intervention can be freely decided by the PRRC and the organisation.
It is extremely important for both the PRRC candidate and the organization to define in a specific, detailed and comprehensive manner the expectations and evidence to support the performance of the tasks set out in Article 15 of MDR (EU) 2017/745.
The very operational description of the tasks should already take place in the appointment letter (in case of internal PRRC) or QTA (in case of external PRRC) in order to protect the interests of both parties and to ensure that in case of any issues, no non-existing responsibilities or undocumented expectations are identified.
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