Regulatory compliance: what lessons can be learned?

The person responsible for regulatory compliance (PRRC) is a new role, as defined in the European medical devices and in vitro diagnostic regulations. Interviews carried out by BioPhorum showed that most manufacturers are yet to appoint a PRRC. So, what are the requirements of this role and how should it be performed?

 

New legal requirement

The EU Medical Devices Regulation (MDR) (EU 2017/745) and In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) introduced a legal requirement for any manufacturer, or their authorized representative, to appoint a person responsible for regulatory compliance. This requirement comes into force either from the date of application of the regulations (26 May 2020 for medical device regulations (MDR) and 26 May 2022 for in vitro diagnostic regulations (IVDR), or if during the transition period, the date that the first device is CE marked under the corresponding regulation.

The PRRC must be available within the manufacturer’s organization and possess the necessary qualifications and experience. “Available within the organization”, in most cases means an employee, with exception being granted to small and micro-businesses (defined as having fewer than 50 employees and no more than €10 million revenue or balance sheet assets). Exception is also granted to the authorized representatives of manufacturers. In these cases, the PRRC may be a contractor, but must be permanently and continuously available. IVDR requirements for the PRRC replicate those of the MDR, with only the reference to in vitro diagnostic qualifications and experience replacing the reference to medical device qualifications and experience. Responsibilities in both cases are identical, namely:

  • Conformity of devices is checked prior to release, in accordance with the quality management system
  • Technical documentation and EU declarations of conformity are maintained
  • Post-market surveillance obligations are complied with
  • Reporting obligations for submission of vigilance reports are fulfilled
  • Compliance of investigational devices is documented

While not identical, much of this sounds like another EU regulated responsible role, the qualified person responsible for pharmacovigilance or QPPV. The QPPV requirement was established in 2004. What lessons and good practices can the PRRC learn from the last 15 years?

Lessons learned

Given that the QPPV role requires oversight and influence, in the early years of adoption many companies included the responsibilities into the job description of the Head of the Pharmacovigilance function. Further, given that the role is an EU requirement, many companies defined the sphere of influence of the QPPV to EU marketed products, as defined in the legislation.

Most large pharmaceutical companies have now established full-time QPPVs and a QPPV office, employing several staff. The remit of these QPPV offices has expanded to global oversight and governance of the pharmacovigilance system, recognition of a reality that product and process experience from anywhere in the globe can potentially impact EU patients and vice-versa. So, what are the success factors for effective deployment of the PRRC role?

Success factors for the PRRC role

  • Oversight of the quality management system, as it applies to medical devices and in vitro diagnostics
  • Engagement throughout the product lifecycle to develop error-proof processes and products
  • Effective monitoring of operational and product risk and the ability to implement mitigating actions
  • Clear governance, decision-making and escalation routes.

This article represents the views of BioPhorum. If you have been appointed as a person responsible for regulatory compliance, or if you are responsible for defining and recruiting for the role, we welcome your thoughts and comments.  Please email Neil Richards at richardsn@biophorum.com.

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