Start with one question: who is the manufacturer?
Under the MDR and IVDR, the manufacturer is not necessarily the factory.
The manufacturer is the legal entity that places the device on the market under its own name or trademark and carries the regulatory responsibilities associated with that role.
That means outsourcing software development, manufacturing, testing or fulfilment does not necessarily outsource the manufacturer's regulatory responsibility.
Before launch, be clear about:
Who owns the product regulatory responsibility?
Everything else follows from that.
Understand the economic operators
The MDR and IVDR assign specific obligations to different actors in the supply chain.
Manufacturer
The manufacturer holds the primary responsibility for regulatory compliance of the device.
This includes areas such as:
- conformity assessment
- technical documentation
- QMS
- risk management
- clinical or performance evaluation
- declaration of conformity
- UDI
- registration
- post-market surveillance
- vigilance
Authorised Representative
A manufacturer established outside the EU generally needs an EU Authorised Representative.
The relationship is established through a written mandate, and the Authorised Representative has specific regulatory responsibilities of its own.
It is therefore more than a postal address.
Importer
The importer places a device from a third country onto the EU market.
Importers have their own verification, identification, registration, storage, complaint and cooperation obligations.
The importer is therefore not simply whichever logistics company happens to move the box across the border.
Distributor
Distributors also have regulatory responsibilities, including checking specified information before making devices available and ensuring appropriate storage and transport conditions.
A company may occupy more than one commercial role, but the regulatory role needs to be understood explicitly.
The European Commission provides dedicated guidance and factsheets for economic operators.
Identify your PRRC
Manufacturers also need access to a Person Responsible for Regulatory Compliance, or PRRC, who meets the qualification requirements of MDR or IVDR Article 15.
The PRRC has defined responsibilities relating to areas including:
- conformity of devices before release
- technical documentation
- post-market surveillance obligations
- regulatory reporting
- investigational devices or performance-study devices where applicable
Micro and small enterprises do not necessarily need to employ the PRRC internally, but must have an appropriately qualified person permanently and continuously at their disposal.
The European Commission's MDCG 2019-7 Rev.1 provides guidance on the PRRC role.
The PRRC should not be added as a name immediately before submission.
The role needs to be integrated into the manufacturer's regulatory system.
Understand UDI
The Unique Device Identification system provides a structured way of identifying medical devices throughout their lifecycle.
For manufacturers this involves concepts including:
- Basic UDI-DI
- UDI-DI
- UDI-PI
- issuing entities
- device and packaging identifiers
- labelling requirements
- device registration
The Basic UDI-DI is particularly important because it connects regulatory records relating to a device family and appears across documentation such as certificates, declarations of conformity and technical documentation.
Do not leave UDI until somebody is preparing the final label.
Its structure can affect regulatory documentation and product configuration decisions earlier than that.
Register the actors
EUDAMED is now part of the practical European market-access process.
Since 28 May 2026, the Actor Registration, UDI/Device, Notified Bodies & Certificates and Market Surveillance modules are mandatory.
The Actor module provides the EU-wide Single Registration Number, or SRN, for relevant economic operators. Manufacturers, authorised representatives and importers are among the actors that may need to register.
For non-EU manufacturers, an active Authorised Representative needs to be in place as part of the actor-registration process.
Register the device
The UDI/Device module also became mandatory on 28 May 2026.
Manufacturers are required to submit the relevant UDI and device information to EUDAMED for devices placed on the EU market.
The Commission provides:
- onboarding materials
- user guides
- data-set specifications
- training recordings
- a UDI helpdesk
- the EUDAMED Information Centre
You can therefore do much of this yourself.
A useful pre-market checklist
Before placing the device on the market, you should be able to answer:
Manufacturer
Which legal entity is taking manufacturer responsibility?
PRRC
Who fulfils Article 15 and how is that responsibility documented?
Authorised Representative
Is one required, and is the mandate in place?
Importer
Who will act as importer for devices entering the EU?
Distributor
Who will distribute the product and have the relevant obligations been addressed?
UDI
Have the Basic UDI-DI and applicable UDIs been assigned correctly?
EUDAMED
Are the necessary actors and devices registered?
Labelling
Do the labels and IFU identify the relevant economic operators correctly?
Records and contracts
Do your quality system and commercial agreements reflect these regulatory roles?
If those questions are answered early, the final steps towards market entry become considerably easier.
Where Fabola comes in
The difficult part is not filling in an EUDAMED form.
It is making sure that the legal, commercial and regulatory structure tells the same story.
Fabola can help you:
- determine who should act as manufacturer
- map economic-operator roles
- establish the appropriate Authorised Representative structure
- distinguish importer and distributor responsibilities
- define PRRC responsibilities
- provide an external PRRC service where appropriate
- establish UDI strategy
- prepare for EUDAMED actor and device registration
- review economic-operator agreements from a regulatory perspective
- integrate these responsibilities into the QMS
- make sure labels, technical documentation and regulatory registrations are consistent
This is particularly useful for startups with outsourced development or manufacturing, international company structures, or supply chains that were designed commercially before anyone considered MDR or IVDR roles.
The aim is simple:
when the product launches, everyone should know who is responsible for what.