Person responsible for regulatory compliance

Professional PRRC Services for Ensuring Medical Device Regulatory Compliance in the EU

A Person Responsible for Regulatory Compliance (PRRC) is essential for navigating the complexities of the Medical Devices Regulation (MDR) 2017/745. This regulation, which came into full effect in May 2021, mandates that all medical device manufacturers appoint a PRRC to ensure compliance with stringent European Union standards. But why exactly do you need a PRRC?

Firstly, the PRRC is your expert in regulatory affairs, ensuring that your medical devices meet all necessary safety and performance requirements. This role is crucial because non-compliance can lead to severe penalties, including medical device product recalls and market bans. Moreover, the PRRC oversees the conformity assessment procedures, making sure that your products are correctly CE marked and documented.

Secondly, having a PRRC demonstrates your company’s commitment to quality and regulatory excellence. Customers and stakeholders are more likely to trust your brand when they know you adhere to rigorous medical device regulatory standards. Additionally, the PRRC acts as a liaison with regulatory authorities, facilitating smoother inspections and audits.

Furthermore, the PRRC is responsible for post-market surveillance, ensuring continuous compliance even after your product hits the market. This includes monitoring adverse events and implementing corrective actions, thereby safeguarding patient safety and maintaining your product’s reputation.

For manufacturers without in-house regulatory expertise, Sobel offers comprehensive PRRC services. Our experts can step in to fulfill this critical role, ensuring your products comply with all regulatory requirements.

In conclusion, appointing a PRRC is not just a regulatory requirement but a strategic move to enhance your company’s credibility and ensure the safety and efficacy of your medical devices. By integrating this role into your compliance framework, you mitigate risks and pave the way for sustainable business growth.

Why do you need this service?

Compliance Assurance: Guarantees adherence to the latest MDR 2017/745 regulations, avoiding costly penalties and recalls.

Expert Guidance: Provides specialized regulatory knowledge, streamlining product approval processes.

Market Access: Ensures products meet international standards, facilitating global market entry and expansion.

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