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Reflections of an external PRRC

As you may know, IVDeology provides compliance support to IVD companies around the world. We love working with SME IVD manufacturers and economic operators (UKRP, Distributors, Importers) who don’t always have sufficient capabilities or bandwidth to address the quality or regulatory compliance needs required under IVD regulations in the EU, UK or rest of the world. Being part of our customer’s compliance support bubble, we can really help them understand how to navigate compliance, either pre-registration or as part of post-market surveillance activities. 

IVD manufacturers who place devices on the EU market, under the EU IVDR, are required to have a Person Responsible for Regulatory Compliance (PRRC), defined under Article 15. For UK SMEs, this role can be outsourced within the same geographic area (the UK). 

The role of a PRRC is to ensure that:

  • The conformity of the device is checked,
  • The Technical Documentation and Declaration of Conformity are available and up to date,
  • Effective post market surveillance is performed,
  • Any performance evaluation studies are performed correctly,

Our team have all had roles similar to this within big IVD companies, and having a good oversight of design & development, change control, risk management and vigilance is key to making sure the device remain compliant. This however can be difficult as an outsider looking in. This is why is it important to build a good relationship and a high level of trust between the manufacturer and external PRRC. But it also requires a good quality and regulatory culture within the manufacturer, even if they do not a QA or RA head count – and this is the tricky bit!

Leadership has an important role to play here, in fostering a great understanding throughout the company of Quality/Regulatory culture, and this should be done as part of the relationship building with the external PRRC. For the business leaders I say – please don’t consider that QA RA compliance responsibilities lies completely with the external party. You still have a responsibility to build an understanding of QARA internally, the external PRRC plays an important role in helping you do this. 

We are aware that this takes an investment of time and unfortunately money, but having an external PRRC, when done right, can make a massive positive difference to your organisation, maintain compliance, and can reduce the need for an additional expensive headcount.

To learn more about the support IVDeology provide, and how to implement the PRRC role, either internally or externally within your organisation, contact Casey for further information.

IVDeology are proud sponsors of TEAM PRRC