In the realm of In-vitro diagnostic Medical devices, regulatory compliance is non-negotiable. The European Union In Vitro Diagnostic Regulation (IVDR) have set stringent standards to ensure the safety and efficiency of medical devices. A pivotal role introduced by these regulations is the Person Responsible for Regulatory Compliance (PRRC). The PRRC is tasked with ensuring that all regulatory requirements are met, from product development through to post-market surveillance. This role is essential for maintaining the quality and safety of medical devices, and compliance with these regulations is mandatory for companies operating within the EU.
However, for many companies, especially small to medium-sized enterprises (SMEs), the challenges associated with maintaining an in-house PRRC can be daunting. This is where outsourcing the PRRC role comes into play. Article 15 of the IVDR allows the utilisation of external PRRCs for micro and small enterprises. IVDeology have a proven track record in providing expert regulatory expertise to SMEs.
Company category | Staff headcount | Turnover | or | Balance sheet total |
Medium-sized | < 250 | ≤ € 50 m | ≤ € 43 m | |
Small | < 50 | ≤ € 10 m | ≤ € 10 m | |
Micro | < 10 | ≤ € 2 m | ≤ € 2 m |
Source: SME definition – European Commission (europa.eu)
Access to Specialised Knowledge
One of the most significant benefits of outsourcing the PRRC role is the access to specialized expertise. Regulatory compliance is a complex and ever-evolving field, requiring a deep understanding of both the regulations and the specific products being developed. Outsourcing to a third-party provider ensures that the PRRC has the necessary experience and knowledge to navigate these complexities. These experts are typically well-versed in the intricacies of the IVDR, and they stay abreast of the latest developments in the regulatory landscape. This level of expertise can be particularly advantageous for companies developing innovative or highly specialized products, as it ensures that all regulatory requirements are met to the highest standards.
Saving Time and Money in the Long Run
Hiring and training an in-house PRRC can be a costly endeavour. The recruitment process itself can be expensive, and once a suitable candidate is found, they need to be trained and continuously educated on the latest regulatory requirements. Additionally, the salary for an experienced PRRC can be substantial. By outsourcing this role, companies can reduce these costs significantly. Third-party providers typically offer their services on a contract basis, which can be more cost-effective than employing a full-time, in-house PRRC. This approach allows companies to allocate their financial resources more efficiently, investing in other critical areas of their business such as research and development, marketing, or expanding their product portfolio.
Our aim is to work with our clients to develop a succession plan for the eventual internal replacement of our virtual PRRC. We will train and mentor the identified internal team members so build the experience required to meet the requirements of Article 15.
Letting Experts Handle Compliance
Regulatory compliance, while essential, is often not a company’s core activity. For many organizations, particularly SMEs, the primary focus is on developing innovative products, enhancing customer experiences, and growing their business. We understand that some organisations may not want to build their regulatory team internally, so we always try to build long term relationships with our customers for continuous support. By outsourcing the PRRC role, companies can allow their internal teams to focus on these core activities. This not only enhances productivity but also ensures that the regulatory compliance function is handled by experts. This separation of duties can lead to better outcomes in both regulatory compliance and overall business performance.
“Regulatory compliance is the responsibility of everyone in the organisation, the PRRCs core responsibility is to observe, reflect and advise on the overall compliance state of the organisation to senior management”
Adapting to Changing Needs
The regulatory landscape is constantly changing, and the demands placed on the PRRC can vary significantly over time. Outsourcing the PRRC role offers companies the flexibility to scale their regulatory compliance efforts up or down as needed. For instance, during periods of intensive product development or regulatory scrutiny, a company may require more comprehensive compliance support. Conversely, during quieter periods, the level of support needed may be reduced. Outsourcing allows companies to adapt to these changing needs without the long-term commitments associated with employing a full-time, in-house PRRC. This flexibility can be particularly beneficial for companies with fluctuating workloads or those operating in highly dynamic industries.
Ensuring Compliance and Avoiding Penalties
Non-compliance with regulatory requirements can result in severe penalties, including fines, product recalls, and even the suspension of business operations. The PRRC plays a crucial role in mitigating these risks by ensuring that all regulatory requirements are met and that any potential issues are addressed promptly. Outsourcing the PRRC role to a reputable third-party provider can enhance this risk mitigation process. These providers have the experience and resources to conduct thorough compliance assessments, implement robust quality management systems, and respond swiftly to any regulatory changes or issues. This proactive approach can help companies avoid the costly consequences of non-compliance and maintain their reputation in the market.
Staying Ahead of Regulatory Changes
The IVD industry is characterized by rapid technological advancements and frequent regulatory updates. Staying ahead of these changes is critical for maintaining compliance and achieving business success. Outsourcing the PRRC role to a third-party provider ensures that companies have access to the latest regulatory knowledge and best practices. These providers invest in continuous education and professional development to stay current with regulatory changes. By leveraging their expertise, companies can continuously improve their compliance processes, adapt to new regulations seamlessly, and maintain a competitive edge in the market.
Giving you a Strategic Advantage
Outsourcing the PRRC role offers numerous benefits for companies operating in the medical device industry. From accessing specialized expertise and achieving cost savings to enhancing focus on core activities and adapting to changing needs, outsourcing provides a strategic advantage. By partnering with a reputable third-party provider, companies can ensure that their regulatory compliance efforts are handled by experts, mitigating risks and driving continuous improvement.
In an industry where compliance is critical to success, outsourcing the PRRC role can be a game-changer, allowing companies to navigate the complexities of regulatory requirements with confidence and achieve their business goals.
For further information on how we can support you, please contact us.
Written by Stuart Angell, Co-founder and Director of IVDeology, part of TEAM PRRC