Supply Chain Management under the

MDR, Brexit and Swixit

2021 EU MDR & IVDR True Quality Summit Series

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Contents

MDR and Key Obligations of the Economic Operators

EU Importer
Brexit – UK Responsible Person & Importer
Swixit – CH-AR and CH-Importer

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Major Changes in MDR 2017/745

Comprehensive overhaul of the Medical Devices Directive (MDD) and Active

Implantable Medical Devices (AIMD) Directives
The scope includes non-medical and cosmetic devices not previously
regulated
Reclassification of many medical devices to a higher risk class and a new
classification for reusable surgical devices requiring notified body oversight.
Manufacturers need to provide more in-depth clinical data (pre and post)
Pivotal role for EUDAMED
Unique Device Identification (UDI) will be implemented to help track devices
throughout the economic operator supply chain and will be required on all
labels.
Initial Date of Application; May 26th, 2020….
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Major Changes in MDR 2017/745, continued

…however, it did not take long before panic set in among stakeholders and a
delay to the 2020 application date became inevitable
And of top of that, COVID added to the challenges to meet MDR compliance
deadlines
Regulation 2020/561 (April 24, 2020) brought some relieve and bought time
Amended MDR Article 120 Transitional Provisions
Allowed for Notified Bodies to continue issue MDD/AIMD certificates until
May 2021, but will become void by May 27, 2024…
…new bottleneck in the making?

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Major Changes in MDR 2017/745, continued

More responsibilities for 4 Economic Operators:

• Legal Manufacturer
• European Authorized Representative
• Importer
• Distributor
A March 2021 MedTech Summer Report included a survey of manufacturers
to determine MDR compliance states and indicated that:
• 17% felt fully ready
• 15% totally not
• 65% use full period of MDD/AIMD certificates

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Major Changes in MDR 2017/745, continued

The Manufacturer must have a clear understanding of the obligations of

the Economic Operators under the MDR and the impact this may have
on their supply chain in Europe

May 26, 2021 is just over two months away!

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MDR and Key Obligations of the
Economic Operators

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 Key Obligations Economic Operators
Authorized
Obligation Importer Distributor
Representative

Device is CE marked and EU declaration of conformity ✓ ✓ ✓

Correct conformity assessment procedure has been performed ✓
Ensure Labelling and accompanying information (IFU) ✓ ✓
/ verify Manufacturer has assigned UDI ✓ ✓
Importer has included name and contact details ✓ ✓
Manufacturer is identified / authorized representative has been assigned ✓
Appoint person responsible for regulatory compliance ✓
Storage and transportation requirements fulfilled ✓ ✓
Keep a register of complaints ✓ ✓ ✓
Inform manufacturer if device provides serious risk / is not in conformity ✓ ✓ ✓
Check Eudamed registration of all Economic Operators ✓ ✓ ✓
Other
Reporting to competent authority re. serious incidents/serious risk ✓ ✓ ✓
Check identification of devices within the supply chain ✓ ✓
Identified on labeling ✓ ✓
Registered in EUDAMED ✓ ✓
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Accountable / Liable ✓ ✓
MDR obligations need to be managed
parallel to the physical & fiscal workflow

Physical
Your shipments via air/sea to Europe

Fiscal
Customs & VAT handling in Europe
Manufacturer
Economic Operator in EU
MDR (e.g. Distributor, Hospital,
Legal access to the European market Clinic)

These flows can be organized

independently of each other!

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Importer under the MDR
“Places a device from a third country on the EU market”
Only places a device on the EU market that complies with the MDR and
verifies compliance
Is liable when placing non-compliant devices on the market
Importer is not necessarily the person who transports the product, but
can be the person on behalf of whom this logistic activity is carried out
(source: EU Blue Guide)
No requirement for physical inspections!

Who can qualify as “Importer”?

EU based legal entity of Legal Manufacturer
European Authorized Representative - EAR
Distributor(s)
3rd Party Logistics Services Provider(s) - 3PL
Independent Importer(s)
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General obligations of Importers
(Article 13)
Only place a device on the EU market that complies with the MDR
Verify:
• The device is CE marked and a Declaration of Conformity has been drawn up
• Manufacturer is identified and European Authorised Representative (EAR) is designated
• Device labelled according to requirements and accompanied by the required Instructions For Use (IFU)
• Unique Device Identification (UDI) has been assigned
Non-compliant products are not placed on the market
Indicate on the device, the device packaging or in a document accompanying the device the importer’s trade name or
trademark, place of business and address
Verify that the device is registered in EUDAMED
Ensure suitable storage and transportation
Register complaints, non-conforming devices, recalls and withdrawals (and keep manufacturer, distributors and EAR
informed)
Inform Competent Authority, the manufacturer and EAR if the importer believes the device is not in conformity with
MDR
Keep copy of Declaration of Conformity and relevant certificates
Cooperate with Competent Authorities
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Who can act as the MDR/IVDR Importer?

Legal Manufacturer Distributor(s) Independent Importer

• Full control
Pro’s • Own name on device /
packaging / document (IFU)
• Easywhen using Ex Works
incoterms – “They are already
importing”
• Central control
• Core activity and
solely
focused on MDR/IVDR role
• Only 1 name on device /
packaging / document (IFU)

• IP sensitivity? Share Tech File?

• Need a legal entity in EU
• Ensure the MDR/IVDR
Con’s obligations and liability in the
EU entity are covered
• Regulatory is not their core
business / role
• More than 1 party involved in • Additional Operator
MDR role – less control
• Multiple names on device /
packaging / document (IFU)

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 Importer related activities
Physical
Fiscal

Each Importation into the EU: When applicable:

Verify: Maintain records of complaints

• CE certification and non-conforming devices
• EU Declaration of Conformity Inform and coordinate with Economic
Manufacturer • Labeling Operator in EU
manufacturer, EAR and/or (e.g. Distributor,
• Identification of EAR, Importer, Competent Authorities Hospital, Clinic)
Manufacturer
• UDI assignment
• EUDAMED registration

Check Transport & Storage conditions

Track Shipments within EU

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 Develop a compliant process

Preparation Execution

Verify compliance with MDR

Receive notifications of intended and shipped
Verify that obligations of economic operators
orders
are covered in contracts
Activities Co-develop an efficient importation process
Verify, monitor and record MDR compliance of
shipments
(examples) around product release and shipment per
Keep record of shipments, nonconformities,
Generic Device Group
complaints
Align and test procedures / SOPs / work
instructions

Deliverables Importer processes ready for execution Compliant Importer process

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Pre-Shipping

Manufacturer

Importer

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Shipping to EU

Manufacturer

Importer

Distributor / (End User)

Note:
could be access to systems of Manufacturer

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Brexit

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Brexit

UK departed from the EU on January 31, 2020 and the Implementation Period
ended on December 31, 2020
UK is now a third country and UK manufacturers will now need to select an
EAR and Importer in the EU
Non-UK based manufacturers will now need to select a UK Responsible
Person (UKRP) and Importer in the UK
Roles of the UKRP and Importer are similar to the roles of the EAR and EU
Importer

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Brexit, continued…

Devices with CE Marking are allowed to be placed on the UK market till

July 1, 2023
As of July 1, 2023, UKCA Marking mandatory
Labeling requires listing of the UK Responsible Person, UK Importer can be
listed on the device, the label or a document accompanying the device
(similar to the MDR)

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Swixit

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Swixit

Current MRA between Union and Switzerland does not cover the MDR
MRA is part of the Institutional Framework Agreement which was rejected in a
Swiss referendum and therefore a new MRA proposal needs to be negotiated
Clock is ticking and not clear whether a signed MRA will be in place before
May 26, 2021
With no MRA in place, Switzerland will become a third country and require
Swiss based manufacturers to select an EAR and Importer for placing devices
on the EU market
Non-Swiss companies will need a “CHAR” and Importer for placing devices
on the Swiss market

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 Economic Operators in “United” Europe

UK RP

Non
EU/UK/Swiss
Manufacturer

CH

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Thanks!
Any questions?

USA Europe
Rene van de Zande Edgar Kasteel
Partner & Commercial Director Partner & Managing Director Visit our website
MedEnvoyGlobal.com
E: rvandezande@MedEnvoyGlobal.com E: ekasteel@MedEnvoyGlobal.com