Economic Operators

Implementation Challenges
and Opportunities
Hilde Viroux
hilde.viroux@paconsulting.com

Bringing Ingenuity to Life

paconsulting.com
Contents

1 What are the new responsibilities of Economic Operators 4

2 How does this impact the Supply Chain 13

3 Key elements for successful implementation 16

4 How to turn compliance into opportunities 18

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 “The supply chain
stuff is really tricky”
Elon Musk,
CEO of Tesla and SpaceX

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1

What are the new

responsibilities of
Economic Operators
 Economic Operators Traceability requirements
have been added to the have been added to
definitions risk classification of
devices and IVDs
In some cases, notified
bodies will have to Each Economic Operator has
inspect distributors specific obligations, including
registration in EUDAMED or
in a national database
(distributors)
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Economic Operators
have to be able to trace the
device using the UDI
(Unique Device Identifier)
Economic Operators
are involved with the
manufacturer’s post market
surveillance activities
 05-2021
MDR transition period
IVDR transition period
Transition period
• Class l devices have
to be compliant to MDR
• >80% of existing IVDs have
to be fully compliant to IVDR
• QMS fully compliant
• Economic operator obligations
met, PRRC assigned
• New devices/IVDs can only go to
market if fully compliant to MDR/IVDR
• EUDAMED economic operator
registration has started
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05-2022
MDR grace period
IVDR grace period
Grace period
• Gradual transfer of remaining
devices with valid MDD/IVDD
certificate to MDR/IVDR in line
with certificate expiry
• EUDAMED data collection and
implementation of a change
management system to keep
the data up to date
05-2024 05-2025
Empty out the
supply chain
Empty out the supply chain
• Manufacturers can no longer sell
any devices that are not compliant
to MDR/IVDR
• Devices in the supply chain can
continue to be sold
• All non-MDR/IVDR compliant
devices have to be removed from
the supply chain after May 2025
 MANUFACTURER IMPORTER DISTRIBUTOR AUTHORIZED
REPRESENTATIVE

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When the legal manufacturer is based in the EU it is simple

• Legal manufacturer is in Belgium

• The devices are made in China • Manufacturer (Belgium)
and coming into the EU through the
port in Rotterdam (Netherlands) • 2 Distributors (France, Poland)

• Distribution centers in France and Poland

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 When the legal manufacturer is not based in the EU, it is more complex

• Legal manufacturer is in the US

• The devices are made in China and coming into the • Manufacturer (US)
EU through the port in Rotterdam (Netherlands) • 2 Distributors (France, Poland)
• Distribution centers in France and Poland • 1 Importer (Germany)
• The affiliate in Germany has financial ownership of • 1 Authorized Representative (Belgium)
the devices when they cross the EU border

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 OBLIGATION IMPORTER DISTRIBUTOR
Register EUDAMED National database
Perform checks ✓ ✓
Name and address on label ✓ -
Keep copy of DoC and certificate ✓ -
Register of complaints ✓ ✓
Forward complaints to manufacturer/ AR/Importer ✓ ✓
Traceability ✓ ✓
Good distribution practices ✓ ✓
Device compliance ✓ ✓
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 Rebranding Repackaging
With a licensing Distributors can change
agreement, and the case count but need to pay
original manufacturer is attention not to tamper the
identified on the label as sterile packaging and
the legal manufacturer keeping the labelling
compliant
Translating the IFU
Distribution can translate
the IFU to ensure local
language requirements
are being met

Without agreement Repackaging and translation activities require

or correct labeling • Procedures
Distributor becomes the • Notification of the legal manufacturer
legal manufacturer and the local authorities
• A notified body inspection

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 Authorized Representatives need to have the processes,
technology and resources in place to fulfill their obligations

MUST HAVE: CANNOT DO: MUST DO:

 A mandate in writing
from the manufacturer
 Liability insurance
 A PRRC permanently
and continuously at
their disposal
 Draw up the DoC  Verify EU DoC and Tech File availability
 Assign and register  Check appropriate conformity
the UDI assessment procedure
 Be responsible for  Keep copies of the documentation and
the manufacturer’s certificates available
QMS  Register in EUDAMED
 Cooperate with the competent authorities
 Inform manufacturer of complaints

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2

How does
this impact the
Supply Chain
 MANUFACTURER LOGISTICS/ PHARMACIES
DISTRIBUTORS

SUPERMARKETS ONLINE OPTICIANS

RETAILERS

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 Medical device companies have usually multiple products, from
multiple production sites, and multiple distributors in the EU.
Ireland Netherlands
Distributor Distributor Distributor Distributor Germany
Distributor
Importer
Distributor Distributor Germany
Belgium Germany Distributor Distributor
Distributor Importer Distributor
Distributor Germany
Poland
UK Importer Importer
Distributor France
Distributor
France
Distributor Belfast Distributor UK Czechia
Importer
Distributor
Distributor UK International Distributor
Distributor Austria Importer Italy Importer
Importer
IMPORTER Austria
Spain Distributor
Distributor Distributor Distributor Espana Importer

Careful mapping of the supply chain and the product flows

is needed to clarify the roles of the various entities
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3

Key elements for

successful
implementation
 Establish and
Start with Transparent
communicate a
mapping out the status reporting
clear set of
supply chain​ to track progress
requirements​

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4

How to turn compliance

into opportunities
 All product moving Reducing Centralizing
into the EU through the number of repackaging /
the same importer distributors translation activities

Simplification of the supply chain leads to more

efficient use of resources and increases compliance

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 paconsulting.com
Hilde Viroux
hilde.viroux@paconsulting.com

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