Who needs to comply?

Applies to

MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746)

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and, where appropriate, a qualified regulatory professional.

Overview

The MDR and IVDR impose obligations not only on manufacturers but on all parties involved in the supply chain of a medical device placed on the EU market. These parties are collectively referred to as economic operators.

The regulations define five key categories of economic operator, each with distinct obligations:

Economic operator	Defined in	Key obligation
Manufacturer	MDR Art. 2(30) / IVDR Art. 2(27)	Ultimate responsibility for device compliance and CE marking
Authorised representative (EU REP)	MDR Art. 2(32) / IVDR Art. 2(29)	Represents non-EU manufacturers; shares legal responsibility
Importer	MDR Art. 2(33) / IVDR Art. 2(30)	Ensures imported devices comply before placing on EU market
Distributor	MDR Art. 2(34) / IVDR Art. 2(31)	Makes devices available on the market; downstream verification
Person responsible for regulatory compliance (PRRC)	MDR Art. 15 / IVDR Art. 15	Individual within the manufacturer/EU REP ensuring compliance

Additionally, healthcare institutions that manufacture or modify devices for internal use have limited in-house exemptions but still face obligations.

How obligations are assigned

Obligations flow primarily based on your role in the supply chain and your geographical relationship to the EU:

Non-EU manufacturer
        │
        └──► EU Authorised Representative (EU REP)
                    │
                    ▼
             EU Importer (if applicable)
                    │
                    ▼
              Distributor(s)
                    │
                    ▼
          End user / healthcare institution

An EU-based manufacturer does not need an EU REP — they deal directly with notified bodies, competent authorities, and the supply chain.

The role of the PRRC

Regardless of which economic operator role you hold (manufacturer or EU REP), you are required to have at least one Person Responsible for Regulatory Compliance (PRRC) within your organisation. The PRRC must have:

Expertise in the field of medical devices (demonstrated by qualification and experience)
Responsibility for ensuring the QMS is implemented and maintained
Responsibility for ensuring Technical Documentation and DoC are prepared and up to date
Responsibility for ensuring post-market obligations are fulfilled

See Person responsible for regulatory compliance for full requirements.

Healthcare institutions

Health institutions that manufacture devices for in-house use (not commercial supply) benefit from a limited exemption under MDR Article 5(5) / IVDR Article 5(5). Conditions include:

The device is not transferred to another legal entity
The device addresses needs that cannot be met by an equivalent marketed device
The institution is accredited under appropriate standards (e.g. EN ISO 15189 for IVD use)
Specific requirements on documentation and incident reporting still apply

This exemption is narrow and does not apply to manufacturing for commercial purposes.

Explore by role

Select your role to see the specific obligations that apply to you:

Official references

Reference	Description
MDR Art. 2(30)–(34)	Definitions of economic operators
MDR Art. 10	General obligations of manufacturers
MDR Art. 11	Authorised representative obligations
MDR Art. 13	Importer obligations
MDR Art. 14	Distributor obligations
MDR Art. 15	PRRC requirements
IVDR Arts. 10–15	Equivalent IVDR obligations
MDCG 2019-6	Guidance on the PRRC

Overview​

How obligations are assigned​

The role of the PRRC​

Healthcare institutions​

Explore by role​

Official references​