concepts of risk management - fdanews...• the iso 13485:2016 guidance document iso 13485:2016...
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Ombu Enterprises, LLCEconomic Operators 1
Economic Operators
Dan O’Leary CBA, CQA, CQE, CRE, SSBB, CIRM
President
Ombu Enterprises, LLC
www.OmbuEnterprises.comOMBUENTERPRISES, LLC
©2020, Ombu Enterprises, LLC
Ombu Enterprises, LLCEconomic Operators 2
Topics• Economic Operator Basics
• EO as a Supplier
• EO as a Regulator
• Manufacturer
• Authorized Representative
• Importer
• Distributor
• EU-MDR Article 22
• Article 16
• Questions
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EO Basics
Economic Operators
Ombu Enterprises, LLC
Point of View
• The presentation takes the point of view of a US based medical device manufacturer selling
devices in the EU
• The Economic Operators have a relationship with the US device manufacturer
– For the US based device Manufacturer, the types of Economic Operators are not the
same as for an EU based device manufacturer
• For convenience, the presentation uses EO for Economic Operator
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Ombu Enterprises, LLC
Definitions
• The types of Economic Operators differ between the EU-MDR and the EU-IVDR.
– There are six in the first case and four in the second
• Economic Operator means a manufacturer, an authorized representative, an importer, a
distributor, or the person referred to in Article 22(1) and 22(3) [EU-MDR Art. 2(35)]
• Economic Operator means a manufacturer, an authorized representative, an importer, or a
distributor [EU-IVDR Art. 2(28)]
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Ombu Enterprises, LLC
Distribution
• The presentation takes the point of view of the US based manufacturer
– Goods flow from the manufacturer to the end user in the distribution channels
– The regulations, on occasion, take the point of view of the end user and use the phrase
“supply chain”
– Goods flow from the suppliers to the manufacturer in the supply channels
• Suppliers, in this sense, are not Economic Operators
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Ombu Enterprises, LLC
EO Definitions• Manufacturer means a natural or legal person who manufactures or fully
refurbishes a device or has a device designed, manufactured, or fully
refurbished, and markets that device under its name or trade mark
• Authorized Representative means any natural or legal person established
within the Union who has received and accepted a written mandate from a
manufacturer, located outside the Union, to act on the manufacturer's behalf
in relation to specified tasks with regard to the latter's obligations under this
Regulation
• Importer means any natural or legal person established within the Union
that places a device from a third country on the Union market
• Distributor means any natural or legal person in the [distribution channels],
other than the manufacturer or the importer, that makes a device available
on the market, up until the point of putting into service
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Ombu Enterprises, LLC
EO Activity
• Making available on the market means any supply of a device, other than an investigational
device, for distribution, consumption, or use on the Union market in the course of a
commercial activity, whether in return for payment or free of charge
• Placing on the market means the first making available of a device, other than an
investigational device, on the Union market
• Putting into service means the stage at which a device, other than an investigational device,
has been made available to the final user as being ready for use on the Union market for the
first time for its intended purpose
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Ombu Enterprises, LLC
Flow Diagrams
• Understanding the role of each company in your distribution
channels is important
• Products flow in one direction from the manufacturer to the EOs to
the end user
– Make a diagram of the product flow naming each party, the type
of EO, and the activity performed
– Different products may have different distribution channels, so
you may need more than one diagram
• Information flows in two ways between the EOs
– Make a diagram of the information flow
– A separate diagram for each type of EO would be valuable
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Ombu Enterprises, LLC
EUDAMED• Eudamed is the “master” database for the EU-MDR and EU-IVDR.
• The database includes the following modules:
– Actors registration (ACT)
– UDI/Devices registration (UDID)
– Notified Bodies and Certificates (CRF)
– Clinical Investigations and performance studies (CIPS)
– Vigilance and post-market surveillance (VGL)
– Market Surveillance (MSU)
• Eudamed availability will be by module; Actor registration is planned for
December 2020. UDI/device registration and Notified Body and Certificates
will become available by May 2021
• The high level functional specification includes public access information for
each module
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Ombu Enterprises, LLC 11
EO As A Supplier
Economic Operators
Ombu Enterprises, LLC
Suppliers
Economic Operators 12
Economic
Operators
Suppliers &
Sub-contractors
Ombu Enterprises, LLC
Supplier Issues
• Under Article 10 the Manufacturer’s QMS includes “selection and control of suppliers and
sub-contractors”
• From the Manufacturer’s point of view the other EOs are service suppliers
• For selection and control follow ISO 13485:2016, 7.4
• The EOs perform an outsourced process, so follow ISO 13485:2016, 4.1.5
– The Clause 7.4 controls include written quality agreements
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Ombu Enterprises, LLC
Quality Agreements• There is a lot of folklore around quality agreements. In particular, when is
one required and what it should cover
• There is only place that requires a quality agreement
– A control for suppliers that perform an outsourced process
• The ISO 13485:2016 guidance document ISO 13485:2016 – Medical
Devices – A Practical Guide says:
– Quality agreements can be in various forms including information
provided on purchase orders or attachments to purchase orders (e.g.,
terms and conditions, specifications, drawings, other documented
information about quality requirements or roles and responsibilities) or a
formal documented separate quality agreement
• Recommendation: Don’t make a separate quality agreement – let the
contract with the EO cover it
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Ombu Enterprises, LLCEconomic Operators 15
EO As A Regulator
Ombu Enterprises, LLC
EO As A Regulator
• As device move through the distribution channels, they pass through the EOs
• The EOs perform checks on the devices and on other EOs
• In addition, the EOs provide information to other EOs
• In the slides below the colors use the following convention except for the Manufacturer:
– An EO requirement is in Green
– A check on a device or another EO is in Red
– Information provided to another EO is in Blue
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SummaryArea Manufacturer
Authorized
Rep Importer Distributor
EO Registration Required Required Required N/A
Device
Registration Required Verifies Verifies N/A
PRRC Required Required N/A N/A
UDI Required N/A Verifies Verifies
DoC Required Verifies Verifies Verifies
IFU Required N/A Verifies Verifies
Complaints Required Forwards Forwards Forwards
Tracing Required N/A Required Required
Market
Surveillance Required
Provides
Information
Provides
Information
Provides
Information
Financial
Liability Required Required N/A N/A
Economic Operators 17
Ombu Enterprises, LLCEconomic Operators 18
Manufacturer
Manufacturer means a natural or legal person who manufactures or fully
refurbishes a device or has a device designed, manufactured, or fully
refurbished, and markets that device under its name or trade mark
Ombu Enterprises, LLC
Flows
• In this view, the Manufacturer is at the center
• Material flows to the Manufacturer through the supply network
• Product flows from the Manufacturer to the Importers and the Distributors through the
distribution network
• Information flows from the Manufacturer to the Authorized Representative
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Ombu Enterprises, LLC
Flows
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Manufacturer
Supplier
Supplier
Supplier
Supplier
Importer
Importer
Distributor
Distributor
Distributor
Distributor
Authorized
RepresentativeMaterial
Product
Information
Ombu Enterprises, LLC
Manufacturer’s Systems
• The Manufacturer, under Article implements a variety of systems:
– Risk Management System, RMS
– Clinical Evaluation System, CES (MDR)
– Performance Evaluation System, PES (IVDR)
– Technical Documentation System, TDS
– Declaration of Conformity & CE Marking
– UDI System
– Record Retention System
– Quality Management system, QMS
– Post-market Surveillance System, PMSS
– Vigilance System
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Ombu Enterprises, LLC
Registration• Source: EU-MDR Art. 31 EU-IVDR Art. 28
• The Manufacturer registers as an Economic Operator in Eudamed
– The Actor Module will be available in December 2020
• The data includes:
– Identity and location of the manufacturer
– Identify and contact information of the PRRC
• The data goes to the Competent Authority for validation, then Eudamed
issues a Single Registration Number, SRN, to the Manufacturer
• ACT: View information on registered economic operators
– Make accessible to the public the actor data, which are not personal
data, entered in Eudamed about the economic operators. Enable the
public to be adequately informed about the relevant economic operators
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Manufacturer
Ombu Enterprises, LLC
Device Registration
• Source: EU-MDR Art. 29 EU-IVDR Art. 26
• The Manufacturer registers each device in Eudamed
– The UDI/device registration Module will be available by May 2021
• The data includes, for each device:
– About 15 data elements for device registration
– About 24 data elements for UDI
– The UDI data elements are loaded at device registration, not when the
UDI is on the device label
• UDID: View information on the registered Basic UDI-DI, UDI-DI and Device
– Eudamed shall enable the public to be adequately informed about
devices placed on the market
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Manufacturer
Ombu Enterprises, LLC
PRRC• Source: EU-MDR Art. 15 EU-IVDR Art. 15
• The Person Responsible for Regulatory Compliance, PRRC, is an
employee of the manufacturer (except for small or micro enterprises)
• The PRRC must have specified technical education and experience
• The PRRC is responsible to ensure the Conformity System, the Technical
Documentation System, The Post-market Surveillance System, and the
Vigilance System
• EO registration includes the identity of the PRRCs
• ACT: View information on registered economic operators
– Make accessible to the public the actor data, which are not personal
data, entered in Eudamed about the economic operators. Enable the
public to be adequately informed about the relevant economic operators
Economic Operators 24
Manufacturer
Ombu Enterprises, LLC
UDI• Source: EU-MDR Art. 27 EU-IVDR Art. 24
• The manufacturer establishes the UDI system
• The Basic UDI-DI defines the device family
• The UDI is the combination of the Device Identifier, DI, and the Production
Identifiers, PI.
– The UDI-DI identify the device and its packaging configurations
– The UDI-PIs define the methods to control production
• The UDI is on the device and packaging labels
• UDID: Download registered Basic UDI-DI and UDI-DI data
– Allow for extract of the Basic UDI-DI and UDI-DI related data
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Manufacturer
Ombu Enterprises, LLC
Declaration of Conformity
• Source: EU-MDR Art. 19 EU-IVDR Art. 17
• The Manufacturer prepares a Declaration of Conformity, DoC
• The DoC is a single document covering all EU legislation for the
device family
– Separate DoCs are no longer allowed
• The DoC includes the Basic UDI-DI, so make it for the device family
• The PRRC ensures the DoC is correct and maintained
• The DoC is not in Eudamed
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Manufacturer
Ombu Enterprises, LLC
Instructions for Use
• Source: EU-MDR Ann. I(23) EU-IVDR Ann. I(20)
• The Manufacturer prepares the Instructions for Use, IFU
– It includes all the required elements in Annex I
– Translate it into the languages of the Member States where the Manufacturer intends to
market the device
– The manufacturer lists the Member States as part of device registration
• The IFU is not in Eudamed
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Manufacturer
Ombu Enterprises, LLC
Complaints
• Source: EU-MDR Ann. III(1)(b)(4th indent) EU-IVDR Ann. III(1)(b)(4th indent)
• The Manufacturer develops and implements effective and appropriate methods and tools to
investigate complaints
• Complaints are not in Eudamed
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Manufacturer
Ombu Enterprises, LLC
Tracing
• Source: EU-MDR Art. 25 EU-IVDR Art. 22
• Manufacturers are able to identify:
– Any EO to whom they have directly supplied a device
– Any EO who has directly supplied them with a device
– Any health institution or healthcare professional to which they have directly supplied a
device
• Eudamed does not include tracing information
Economic Operators 29
Manufacturer
Ombu Enterprises, LLC
Market Surveillance
• Source: EU-MDR Chapter VII Section 3 EU-IVDR Chapter VII Section 3
• The Manufacturer implement procedures to respond to market surveillance activities:
– Competent Authority inspections
– Devices presenting an unacceptable risk to health and safety
– Non-compliant products
– Preventive health protection measures
• MSU: View a summary of the results of the reviews and assessments of the market surveillance
activities of a Member State
– Make accessible to the public summaries of the results of the reviews and assessments of the
market surveillance activities of the Member State
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Manufacturer
Ombu Enterprises, LLC
Financial Liability
• Source: EU-MDR Art. 10(16) EU-IVDR Art. 10(15)
• Manufacturers have sufficient financial coverage for liability under Directive 85/374/EEC that
is proportionate to the risk class, type of device, and the size of the enterprise
• Eudamed does not include financial liability
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Manufacturer
Ombu Enterprises, LLCEconomic Operators 32
Authorized Representative
Authorized Representative means any natural or legal person established
within the Union who has received and accepted a written mandate from a
manufacturer, located outside the Union, to act on the manufacturer's behalf
in relation to specified tasks with regard to the latter's obligations under this
Regulation
Ombu Enterprises, LLC
Registration• Source: EU-MDR Art. 31 & Art. 11(3)(c) EU-IVDR Art. 28 & Art. 11(3)(c)
• The Authorized Rep registers as an Economic Operator in Eudamed
– The Actor Module will be available in December 2020
• The data includes:
– Identity and location of the Authorized Rep
– Identify and contact information of the PRRC
• The data goes to the Competent Authority for validation, then Eudamed
issues a Single Registration Number, SRN, to the Manufacturer
• ACT: View information on registered economic operators
– Make accessible to the public the actor data, which are not personal
data, entered in Eudamed about the economic operators. Enable the
public to be adequately informed about the relevant economic operators
Economic Operators 33
Authorized Rep
Ombu Enterprises, LLC
PRRC• Source: EU-MDR Art. 15 EU-IVDR Art. 15
• The Person Responsible for Regulatory Compliance, PRRC, is permanently
and continuously at the disposal of the Authorized Rep
• The PRRC must have specified technical education and experience
• The PRRC verifies the Manufacturer’s DoC, Technical documentation, etc.
under Art. 11(3)(a)
• EO registration includes the identity of the PRRCs
• ACT: View information on registered economic operators
– Make accessible to the public the actor data, which are not personal
data, entered in Eudamed about the economic operators. Enable the
public to be adequately informed about the relevant economic operators
Economic Operators 34
Authorized Rep
Ombu Enterprises, LLC
Registration Checks
• Source: EU-MDR Art. 11(3)(c) EU-IVDR Art. 11(3)(c)
• Verify that the manufacturer complied with the device registration
requirements
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Authorized Rep
Ombu Enterprises, LLC
Technical Documentation
• Source: EU-MDR Art. 11(3)(a) EU-IVDR Art. 11(3)(a)
• Verify that the Manufacturer prepared the DoC, prepared the technical documentation, and
followed an appropriate conformity assessment procedure
• Source: EU-MDR Art. 11(3)(b) EU-IVDR Art. 11(3)(b)
• Maintain a copy of the Manufacturer’s technical documentation, the Manufacturer’s DoC, and
the NB’s certificates, including any amendments and supplements
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Authorized Rep
Ombu Enterprises, LLC
Market Surveillance
• Source: EU-MDR Art. 11(3)(d) EU-IVDR Art. 11(3)(d)
• If requested by a Competent Authority provide, in an official Union language determined by
the Member State, the information and documentation necessary to demonstrate device
conformity
• Source: EU-MDR Art. 11(3)(e) EU-IVDR Art. 11(3)(e)
• Forward a Competent Authority’s request for samples or device access to the manufacturer.
Verify that the Competent Authority received the samples or the access
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Authorized Rep
Ombu Enterprises, LLC
Complaints
• Source: EU-MDR Art. 11(3)(g) EU-IVDR Art. 11(3)(g)
• Immediately inform the Manufacturer about complaints and reports from healthcare
professionals, patients, and users about suspected incidents related to a device
Economic Operators 38
Authorized Rep
Ombu Enterprises, LLC
Financial Liability
• Source: EU-MDR Art. 11(5) EU-IVDR Art. 11(5)
• Where the Manufacturer has not complied with the obligations laid down in Article 10, the
authorized representative is legally liable for defective devices on the same basis as, and
jointly and severally with, the Manufacturer
Economic Operators 39
Authorized Rep
Ombu Enterprises, LLCEconomic Operators 40
Importer
Importer means any natural or legal person established within the Union that
places a device from a third country on the Union market
Ombu Enterprises, LLC
Registration• Source: EU-MDR Art. 31 & Art. 13(4) EU-IVDR Art. 28 & Art. 13(4)
• The Importer registers as an Economic Operator in Eudamed
– The Actor Module will be available in December 2020
• The data includes:
– Identity and location of the Importer
• The data goes to the Competent Authority for validation, then Eudamed
issues a Single Registration Number, SRN, to the Manufacturer
• ACT: View information on registered economic operators
– Make accessible to the public the actor data, which are not personal
data, entered in Eudamed about the economic operators. Enable the
public to be adequately informed about the relevant economic operators
Economic Operators 41
Importer
Ombu Enterprises, LLC
CE Mark & DoC
• Source: EU-MDR Art. 14(2)(a) EU-IVDR Art. 14(2)(a)
• Verify that the Manufacturer put the CE Mark on the device and prepared the Declaration of
Conformity
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Importer
Ombu Enterprises, LLC
Identification
• Source: EU-MDR Art. 13(2)(b) EU-IVDR Art. 13(2)(b)
• Verify the identification of the Manufacturer
• Verify that the Manufacturer designated an Authorized Representative
• Note: EU-MDR Ann. I(20.2)(c & d) require the identity of the Manufacturer and the
Authorized Representative on the device label
• Note: EU-IVDR Ann. I(23.2)(c & d) require the identity of the Manufacturer and the
Authorized Representative on the device label
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Importer
Ombu Enterprises, LLC
Identification (Importer)
• Source: EU-MDR Art. 13(3) EU-IVDR Art. 13(3)
• Indicate on the device, its packaging, or in a document accompanying the device the
Importer’s name, registered trade name or registered trade mark, registered place of
business, and their contact address.
• The Importer ensures that any additional label doesn’t obscure any Manufacturer’s
information on the label.
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Importer
Ombu Enterprises, LLC
Labeling
• Source: EU-MDR Art. 13(2)(c) EU-IVDR Art. 13(2)(c)
• Verify that the Manufacturer labeled the device in accordance with the regulation and
provided the Instructions for Use
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Importer
Ombu Enterprises, LLC
UDI
• Source: EU-MDR Art. 13(2)(d) EU-IVDR Art. 13(2)(d)
• Verify that the Manufacturer assigned a UDI
• UDID: Download registered Basic UDI-DI and UDI-DI data
– Allow for extract of the Basic UDI-DI and UDI-DI related data
Economic Operators 46
Importer
Ombu Enterprises, LLC
Device Registration
• Source: EU-MDR Art. 13(4) EU-IVDR Art. 13(4)
• Verify that the Manufacturer registered the device in Eudamed
• UDID: View information on the registered Basic UDI-DI, UDI-DI and Device
– Eudamed shall enable the public to be adequately informed about devices placed on the
market
Economic Operators 47
Importer
Ombu Enterprises, LLC
Suitable Conditions
• Source: EU-MDR Art. 13(5) EU-IVDR Art. 13(5)
• Ensure that, while a device is under their responsibility, storage or transport conditions do
not jeopardies compliance with Annex I
• Ensure compliance with the conditions set by the manufacturer
Economic Operators 48
Importer
Ombu Enterprises, LLC
Complaints
• Source: EU-MDR Art. 13(8) EU-IVDR Art. 13(8)
• Immediately forward to the Manufacturer and the Authorized Representative any complaint
or reports from healthcare professionals, patients, or users about suspected incidents
• Source: EU-MDR Art. 13(6) EU-IVDR Art. 13(6)
• Maintain a register of complaints, non-conforming devices, recalls, and withdrawals
• Provide any requested complaint information to the Manufacturer, Authorized
Representative, or Distributor
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Importer
Ombu Enterprises, LLC
Record Retention
• Source: EU-MDR Art. 13(9) EU-IVDR Art. 13(9)
• Maintain a copy of the Manufacturer’s DoC and the NB’s certificates, including any
amendments and supplements
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Importer
Ombu Enterprises, LLC
Tracing
• Source: EU-MDR Art. 25 EU-IVDR Art. 22
• Importers are able to identify:
– Any EO to whom they have directly supplied a device
– Any EO who has directly supplied them with a device
– Any health institution or healthcare professional to which they have directly supplied a
device
• Eudamed does not include tracing information
Economic Operators 51
Importer
Ombu Enterprises, LLC
Market Surveillance
• Source: EU-MDR Art. 13(10) EU-IVDR Art. 13(10)
• Cooperate with Competent Authorities on any action taken to eliminate or mitigate the risks
posed by devices which they have placed on the market.
• Upon request by a Competent Authority, provide samples of the device free of charge or,
where that is impracticable, grant access to the device
Economic Operators 52
Importer
Ombu Enterprises, LLCEconomic Operators 53
Distributor
Distributor means any natural or legal person in the [distribution] chain, other
than the manufacturer or the importer, that makes a device available on the
market, up until the point of putting into service
Ombu Enterprises, LLC
CE Mark & DoC
• Source: EU-MDR Art. 14(2)(a) EU-IVDR Art. 14(2)(a)
• Verify that the Manufacturer put the CE Mark on the device and prepared the Declaration of
Conformity
• The Distributor may apply a sampling method that is representative of the devices supplied
by that distributor
Economic Operators 54
Distributor
Ombu Enterprises, LLC
Labels & IFU
• Source: EU-MDR Art. 14(2)(b) EU-IVDR Art. 14(2)(b)
• Verify that the device is accompanied by the information to be supplied by the Manufacturer
in accordance with Annex I section on the label and the instructions for use
• The Distributor may apply a sampling method that is representative of the devices supplied
by that distributor
Economic Operators 55
Distributor
Ombu Enterprises, LLC
Importer’s Identification
• Source: EU-MDR Art. 14(2)(c) EU-IVDR Art. 14(2)(c)
• For imported devices, verify that the Importer’s identification is on the device, its packaging,
or in a document accompanying the device
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Distributor
Ombu Enterprises, LLC
UDI
• Source: EU-MDR Art. 14(2)(d) EU-IVDR Art. 14(2)(d)
• Verify that the Manufacturer assigned a UDI
• The Distributor may apply a sampling method that is representative of the devices supplied
by that distributor
• UDID: Download registered Basic UDI-DI and UDI-DI data
– Allow for extract of the Basic UDI-DI and UDI-DI related data
Economic Operators 57
Distributor
Ombu Enterprises, LLC
Suitable Conditions
• Source: EU-MDR Art. 14(3) EU-IVDR Art. 14(3)
• Ensure that, while a device is under their responsibility, storage or transport conditions
comply with the conditions set by the manufacturer
Economic Operators 58
Distributor
Ombu Enterprises, LLC
Complaints
• Source: EU-MDR Art. 14(5) EU-IVDR Art. 14(5)
• Immediately forward to the Manufacturer, the Authorized Representative, and the Importer
any complaint or reports from healthcare professionals, patients, or users about suspected
incidents
• Maintain a register of complaints, non-conforming devices, recalls, and withdrawals
• Provide any requested complaint information to the Manufacturer, Authorized
Representative, or Importer
Economic Operators 59
Distributor
Ombu Enterprises, LLC
Tracing
• Source: EU-MDR Art. 25 EU-IVDR Art. 22
• Distributors are able to identify:
– Any EO to whom they have directly supplied a device
– Any EO who has directly supplied them with a device
– Any health institution or healthcare professional to which they have directly supplied a
device
• Eudamed does not include tracing information
Economic Operators 60
Distributor
Ombu Enterprises, LLC
Market Surveillance
• Source: EU-MDR Art. 14(6) EU-IVDR Art. 14(6)
• Cooperate with Competent Authorities on any action taken to eliminate or mitigate the risks
posed by devices which they have placed on the market.
• Upon request by a Competent Authority, provide samples of the device free of charge or,
where that is impracticable, grant access to the device
• If requested by a Competent Authority provide any documentation necessary to demonstrate
device conformity
Economic Operators 61
Distributor
Ombu Enterprises, LLCEconomic Operators 62
EU-MDR Article 22
Ombu Enterprises, LLC
EOs
• In the EU-MDR, economic operators include:
– The person referred to in Article 22(1)
• A natural or legal person that combines devices bearing a CE mark with other devices
or products, in a manner that is compatible with the intended purpose of the devices
or other products and within the limits of use specified by their manufacturers, in order
to place them on the market as a system or procedure pack
– The person referred to in Article 22(3)
• Any natural or legal person who sterilizes systems or procedure packs for the purpose
of placing them on the market
Economic Operators 63
Art. 22
Ombu Enterprises, LLC
Definitions
• Procedure pack means a combination of products packaged together and placed on the
market with the purpose of being used for a specific medical purpose [Art. 2(10)]
• System means a combination of products, either packaged together or not, which are
intended to be inter-connected or combined to achieve a specific medical purpose [Art.
2(11)]
Economic Operators 64
Art. 22
Ombu Enterprises, LLC
Combining Products
• A system or procedure pack includes devices with a CE Mark combined with:
– Other devices bearing the CE Mark
– In vitro diagnostic medical devices with the CE Mark in conformity with the EU-IVDR
– Other products in conformity with legislation that applies to those products only where
they are used within a medical procedure or their presence in the system or procedure
pack is otherwise justified
Economic Operators 65
Art. 22
Ombu Enterprises, LLC
Statement• The person assembling a system or procedure prepares a statement
that declares:
– They verified the mutual compatibility of the devices and, if
applicable other products, in accordance with the manufacturers'
instructions and have carried out their activities in accordance
with those instructions
– They packaged the system or procedure pack and supplied
relevant information to users incorporating the information to be
supplied by the manufacturers of the devices or other products
which have been put together
– The activity of combining devices and, if applicable, other
products, as a system or procedure pack was subject to
appropriate methods of internal monitoring, verification, and
validation Economic Operators 66
Art. 22
Ombu Enterprises, LLC
Labels and Labeling
• Systems and procedure packs do not have a CE Mark
• They have the name, registered trade name or registered trade mark, and address of person
that assembled the system or procedure pack
• They have the name, registered trade name or registered trade mark, and address of person
that sterilized the system or procedure pack
• The system or procedure pack is accompanied by the Annex I(23) information on the label
and the IFU
Economic Operators 67
Art. 22
Ombu Enterprises, LLC
Exception
• IF the system or procedure pack:
– Incorporates devices that don’t have the CE Mark OR
– The combination of devices is not compatible in view of their original intended purpose
OR
– The sterilization has not been carried out in accordance with the manufacturer's
instructions
• THEN treat the system or procedure pack as a device in its own right
• It is subject to conformity assessment in Article 52
• The natural or legal person assumes the obligations of a manufacturer
Economic Operators 68
Art. 22
Ombu Enterprises, LLCEconomic Operators 69
Article 16
Ombu Enterprises, LLC
Becoming a Manufacturer
• A Distributor, Importer, or other natural or legal person assumes the obligations of a Manufacturer if it:
– Makes available on the market a device under its name, registered trade name, or registered trade
mark
• Except when there is an agreement that the manufacture is identified on the label and is
responsible for compliance with the regulation
• Except when the person adapts a device already on the market for an individual patient without
changing its intended purpose
– Changes the intended purpose of a device already placed on the market or put into service
– Modifies a device already placed on the market or put into service in such a way that compliance
with the applicable requirements may be affected
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Ombu Enterprises, LLC
Except
• The following activities don’t affect regulatory compliance:
– Providing, including translation, the information supplied by the manufacturer in Annex I for a
device already placed on the market or additional information required in a Member State
– Changes to the outer packaging of a device already placed on the market, including a change of
pack size, if the repackaging is necessary in order to market the device in the relevant Member
State
• The repackaging doesn’t affect the original condition of the device
• For sterile devices, the original condition of the device is adversely affected if the packaging to
maintain the sterile condition is opened, damaged, or otherwise negatively affected
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Ombu Enterprises, LLC
Status
• Consider an Importer or Distributor who performs these activities as a relabeler or repackager
– There are not EU-MDR or EU-IVDR terms but help clarify the status
• For the device, include the activity carried out with the name and address of the company
• Implement a QMS that includes:
– Accurate and up-to-date translation
– Proper conditions for repackaging or relabeling
– Information from the Manufacturer on any corrective actions taken
• At least 28 days before repackaging or relabeling, inform the Manufacturer and the Competent
Authority and provide a sample
• At least 28 before repackaging or relabeling submit an NB certificate to the Competent Authority
attesting a compliant QMS
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Questions