MDCG 2019-7: Person responsible for regulatory compliance (PRRC), explained

Who needs a PRRC

Manufacturers placing devices on the Union market and authorised representatives of non-EU manufacturers must have at least one person responsible for regulatory compliance available under Article 15 MDR or IVDR. The obligation also follows entities that assume manufacturer obligations, including certain Article 16 operators and system or procedure-pack producers.

The PRRC is not a transfer of legal responsibility. The manufacturer remains responsible for device conformity; the PRRC verifies that the relevant regulatory processes are operating and receives the information needed to perform the role.

The qualification routes

For a manufacturer or authorised representative, the usual routes are:

Experience should be substantive, recent and related to EU medical-device or IVD requirements. Keep the CV, qualifications and evidence of actual professional experience in the controlled appointment file; a job title alone does not demonstrate eligibility.

Internal versus external PRRC

Manufacturers that are not micro or small enterprises must have the PRRC within their organisation. A micro or small enterprise may contract an external PRRC, provided the person is permanently and continuously at its disposal.

That phrase does not require 24-hour availability. It does require a contract and operating arrangement that lets the PRRC perform duties and react in time. Define availability, deputies, access to records, escalation, conflicts, termination and handover—not just an hourly consulting rate.

The guidance assumes that an EU manufacturer and its PRRC are located in the Union, while a non-EU manufacturer and its manufacturer-side PRRC are outside the Union and in reasonable proximity to the manufacturing activities. The authorised representative's PRRC should be in the Union.

What the role must cover

The manufacturer's PRRC must ensure that:

• device conformity is appropriately checked before release;
• technical documentation and declarations of conformity are prepared and kept current;
• post-market surveillance obligations are met;
• vigilance reporting obligations are fulfilled; and
• the required statement is issued for investigational devices or performance-study IVDs.

The PRRC should be involved in the processes needed to verify those outcomes and have access to nonconformities and other relevant information. The role may use audits or sampling; it does not need to personally execute every operational task.

The person must suffer no disadvantage for properly performing these duties. Record an independent escalation route so regulatory objections cannot be silently overridden by the same manager whose release is being challenged.

Manufacturer and authorised representative need independent scrutiny

The authorised representative's PRRC ensures that the representative's mandate and Article 11 tasks are fulfilled. The same individual cannot act as PRRC for a non-EU manufacturer and its authorised representative. For micro or small manufacturers, the two PRRCs must not belong to the same external organisation either.

What this means for you, practically

1. Classify the company. Document whether the manufacturer meets the EU micro/small-enterprise thresholds and whether an external PRRC route is available.
2. Build an evidence file. Keep qualifications, relevant experience, scope, availability and conflict checks with the signed appointment.
3. Map Article 15 to procedures. Name the records the PRRC reviews or samples for release, technical documentation, PMS, vigilance and investigations.
4. Protect the role. Define information access and a direct escalation path, including what happens when the PRRC refuses to support a release.
5. Maintain EUDAMED data. Register the PRRC contact details and update changes within the applicable one-week period.

Use the PRRC Appointment Letter to document the appointment, then tailor it to the actual responsibilities and availability arrangement.

Read the official MDCG 2019-7 Rev.1 guidance.