PRRC vs UKRP: Navigating medical device regulatory responsibilities

Medical device manufacturers operating in both the EU and UK must comply with distinct regulatory frameworks. Two key roles in this space are the Responsible Person for Regulatory Compliance (PRRC), which is a requirement under the EU MDR (2017/745) and IVDR (2017/746), and the UK Responsible Person (UKRP), which is mandated under the UK MDR 2002 (SI 2002/618, as amended). While their names may sound similar, their responsibilities and legal implications are quite different.

The role of the PRRC under EU MDR

The PRRC is an essential figure in an EU-based medical device manufacturer’s organization. This individual is responsible for ensuring compliance with various regulatory requirements. Their duties cover a wide range of responsibilities, including overseeing conformity assessments and technical documentation, verifying the accuracy of the EU Declaration of Conformity, and managing post-market surveillance activities. Additionally, the PRRC must ensure timely reporting of serious incidents and implement field safety corrective actions (FSCAs) when necessary.

The role of the PRRC is legally bound to the manufacturer. This means that the PRRC must be an internal team member rather than an external consultant or organization. While PRRCs are generally not held personally liable for ordinary negligence, they can be held accountable in cases of gross negligence or intentional misconduct. Due to the complexity and critical nature of this role, individuals appointed as PRRCs must possess specific qualifications and expertise in medical device regulations.

The role of the UKRP under UK MDR

Unlike the PRRC, the UK Responsible Person (UKRP) is primarily concerned with market access for manufacturers based outside the UK. Any medical device manufacturer that is not established in the UK must appoint a UKRP to legally place their products on the UK market. The UKRP acts as the official regulatory contact between the manufacturer and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The UKRP has the legal authority to register medical devices on behalf of the manufacturer in the MHRA’s database, ensuring compliance with UK-specific regulations. While the PRRC must be an internal role, the UKRP can be an external entity such as an importer or distributor, offering more flexibility for manufacturers.

A key aspect of UKRP compliance is product labeling. When a device is marked with the UKCA (UK Conformity Assessed) mark, the UKRP’s details must be included in the product labeling or instructions for use. However, if a product carries only a CE mark, the UKRP’s details are not required unless both CE and UKCA markings are displayed.

Understanding the differences

While both the PRRC and UKRP play crucial roles in regulatory compliance, their scope and focus differ significantly. The PRRC oversees comprehensive regulatory compliance across all aspects of a medical device’s lifecycle within the EU. In contrast, the UKRP is more focused on market access and regulatory communication for non-UK manufacturers looking to sell their devices in the UK.

For companies operating across both the EU and UK, it is vital to understand these distinctions to ensure compliance in both markets. The PRRC ensures internal regulatory oversight, while the UKRP facilitates external market access and communication with UK authorities. Navigating these roles effectively will help manufacturers maintain seamless compliance across different regulatory environments.