M
MDR/IVDR Training

Economic Operators & PRRC

30 minCore

Learning Objectives

By the end of this module you will be able to:

  • 1Identify the four categories of economic operator under MDR/IVDR (manufacturer, authorised representative, importer, distributor)
  • 2Explain the specific obligations of each economic operator under Articles 10–16
  • 3Describe the qualifications and responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under Article 15
  • 4Recognise when obligations transfer between economic operators (Article 16) and the implications for hospitals
Content reviewed: March 2026

Who's Who in the Supply Chain?

MDR Articles 10–16 define the four types of economic operator in the medical device supply chain and their specific legal obligations. Understanding who is responsible for what helps you know who to contact when things go wrong — and what checks should have already been done before a device reaches your ward.

Why This Matters to Healthcare Workers

Know who to contact when a device fails or an FSN is issued
Understand what verification should have happened before a device reached you
Support procurement in asking the right questions when buying devices
Recognise your facility's PRRC and know their role

The Device Supply Chain — From Factory to Ward

🏭

Manufacturer

Article 10
🌐

Authorised Representative

Article 11
🚢

Importer

Article 13
📦

Distributor

Articles 14
🏥 Your Hospital

Obligations in Detail

Manufacturer

Article 10

Designs, makes, and is legally responsible for the device

Core Obligations
Establish and maintain a Quality Management System (QMS) — typically ISO 13485
Prepare and keep up-to-date technical documentation (Annex II & III)
Carry out conformity assessment and affix CE marking
Assign UDI and register devices in EUDAMED
Implement post-market surveillance (PMS) and vigilance reporting
Appoint a Person Responsible for Regulatory Compliance (PRRC)
Ensure devices are designed and manufactured per General Safety and Performance Requirements (Annex I)
Maintain traceability and cooperate with Competent Authorities
Hospital Relevance

The manufacturer is your primary point of accountability. When a device fails, they own the investigation. When a recall happens, the Field Safety Notice comes from them. Always know who manufactured your critical devices.

Key Documents
Technical Documentation
EU Declaration of Conformity
PMS Plan
PMS Report / PSUR
Instructions for Use (IFU)

Authorised Representative

Article 11

Acts on behalf of a non-EU manufacturer within the EU

Importer

Article 13

First to place a non-EU device on the EU market

Distributor

Articles 14

Makes a device available on the market after initial placement

Person Responsible for Regulatory Compliance (PRRC)
Article 15

Article 15 is one of the most significant additions in MDR/IVDR. It requires manufacturers and authorised representatives to have at least one named person within their organisation who is responsible for regulatory compliance. This person must have proven qualifications.

Required Qualifications (Article 15(1))

The PRRC must possess one of the following:

Option A: A diploma, certificate, or other evidence of formal qualification in law, medicine, pharmacy, engineering, or another relevant discipline + at least one year of professional experience in regulatory affairs or QMS for medical devices
Option B: Four years of professional experience in regulatory affairs or QMS for medical devices

MDCG 2019-7 provides additional guidance. For micro/small enterprises, the PRRC doesn't have to be an employee — they can be an external consultant available on a permanent and continuous basis.

When Obligations Transfer

Article 16

Critical: when importers/distributors become manufacturers

At a Glance — Who Does What?

Obligation🏭 Mfr🌐 AR🚢 Imp📦 Dist
Establish QMS✅❌❌❌
Technical Documentation✅📄❌❌
Conformity Assessment / CE Mark✅❌❌❌
Assign UDI✅❌❌❌
Register in EUDAMED✅✅✅❌
Appoint PRRC✅✅❌❌
PMS & Vigilance Reporting✅❌❌❌
Verify CE Mark & DoC—📄✅✅
Verify Labelling & IFU✅❌✅✅
Storage & Transport✅❌✅✅
Complaint Register✅❌✅❌
Cooperate with Authorities✅✅✅✅

✅ = Required · 📄 = Must keep copy available · ❌ = Not required · — = Not applicable

Quick Knowledge Checks

Q1.A hospital receives a device from a non-EU manufacturer via an EU-based importer. Who is responsible for verifying the CE mark before the device enters the EU market?

The hospital
The importer
The HPRA
The patient

Q2.What must a distributor do if they believe a device in their possession does not conform to MDR requirements?

Sell it at a discount
Not make it available on the market until compliance is confirmed
Ignore it and let the manufacturer handle it
Report directly to the EU Commission

Q3.Which economic operator is required to appoint a Person Responsible for Regulatory Compliance (PRRC)?

Distributors only
Importers only
Manufacturers and Authorised Representatives
All economic operators

Q4.Under Article 16, when does a distributor assume manufacturer obligations?

When they store devices in a warehouse
When they modify the device or change its intended purpose
When they sell devices to a hospital
When the manufacturer goes bankrupt

Key Takeaways

Four economic operators form the supply chain: manufacturer, authorised rep, importer, distributor
The manufacturer carries the heaviest obligations — from design to post-market
Article 15 PRRC is a named, qualified person with legal protections
Article 16 can turn a distributor into a manufacturer if they modify devices
Hospitals should know who manufactured and distributed their critical devices
Procurement should verify CE marks, UDI, and DoC availability at point of purchase

Regulatory References

MDR Article 10 (Manufacturer Obligations)
MDR Article 11 (Authorised Representative)
MDR Article 12 (Change of AR)
MDR Article 13 (Importer Obligations)
MDR Article 14 (Distributor Obligations)
MDR Article 15 (PRRC)
MDR Article 16 (Obligation Transfer)
MDCG 2019-7 (PRRC Guidance)

Knowledge Check

8 questions · 80% required to pass

Q1.Which economic operator bears the heaviest regulatory obligations under MDR?

Q2.What is the primary role of an Authorised Representative under MDR Article 11?

Q3.Under MDR Article 13, what must an importer verify BEFORE placing a non-EU device on the EU market?

Q4.What qualification is required for a Person Responsible for Regulatory Compliance (PRRC) under Article 15?

Q5.A distributor relabels a CE-marked device and sells it under their own brand name. What happens under Article 16?

Q6.Which economic operators are required to appoint a PRRC?

Q7.What protection does Article 15(5) provide to the PRRC?

Q8.Your hospital wants to modify an infusion pump's software beyond what the manufacturer intended. Under Article 16, what is the regulatory implication?

0/8 answered

Print-Friendly Summary

One-page PDF for ward reference & quick revision

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