concepts of risk management - fdanews...• the iso 13485:2016 guidance document iso 13485:2016...

Ombu Enterprises, LLCEconomic Operators 1

Economic Operators

Dan O’Leary CBA, CQA, CQE, CRE, SSBB, CIRM

President

Ombu Enterprises, LLC

[email protected]

www.OmbuEnterprises.comOMBUENTERPRISES, LLC

©2020, Ombu Enterprises, LLC

mailto:[email protected]

http://www.ombuenterprises.com/


Topics• Economic Operator Basics

• EO as a Supplier

• EO as a Regulator

• Manufacturer

• Authorized Representative

• Importer

• Distributor

• EU-MDR Article 22

• Article 16

• Questions

Ombu Enterprises, LLC 3

EO Basics

Economic Operators


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

Economic Operators 4


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)]



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



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



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



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



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


Ombu Enterprises, LLC 11

EO As A Supplier

Economic Operators


Suppliers


Economic

Operators

Suppliers &

Sub-contractors


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



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



EO As A Regulator


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



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



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


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



Flows


Manufacturer

Supplier

Supplier

Supplier

Supplier

Importer

Importer

Distributor

Distributor

Distributor

Distributor

Authorized

RepresentativeMaterial

Product

Information


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



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


Manufacturer


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


Manufacturer


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






Manufacturer


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


Manufacturer


Declaration of Conformity


• 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


Manufacturer


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


Manufacturer


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


Manufacturer


Tracing


• 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


Manufacturer


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


Manufacturer


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


Manufacturer


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


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



– Identity and location of the Authorized Rep

– Identify and contact information of the PRRC








Authorized Rep


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






Authorized Rep


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


Authorized Rep


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


Authorized Rep


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


Authorized Rep


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


Authorized Rep


Financial Liability


• 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


Authorized Rep


Importer

Importer means any natural or legal person established within the Union that

places a device from a third country on the Union market


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



– Identity and location of the Importer








Importer


CE Mark & DoC


• Verify that the Manufacturer put the CE Mark on the device and prepared the Declaration of

Conformity


Importer


Identification


• 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


Importer


Identification (Importer)


• 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.


Importer


Labeling


• Verify that the Manufacturer labeled the device in accordance with the regulation and

provided the Instructions for Use


Importer


UDI


• Verify that the Manufacturer assigned a UDI




Importer


Device Registration


• 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


Importer


Suitable Conditions


• 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


Importer


Complaints


• Immediately forward to the Manufacturer and the Authorized Representative 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 Distributor


Importer


Record Retention


• Maintain a copy of the Manufacturer’s DoC and the NB’s certificates, including any

amendments and supplements


Importer


Tracing


• Importers are able to identify:




device



Importer


Market Surveillance


• 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


Importer


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


CE Mark & DoC


• 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


Distributor


Labels & IFU


• 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


by that distributor


Distributor


Importer’s Identification


• For imported devices, verify that the Importer’s identification is on the device, its packaging,

or in a document accompanying the device


Distributor


UDI


• Verify that the Manufacturer assigned a UDI


by that distributor




Distributor


Suitable Conditions


• Ensure that, while a device is under their responsibility, storage or transport conditions

comply with the conditions set by the manufacturer


Distributor


Complaints


• 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


Distributor


Tracing


• Distributors are able to identify:




device



Distributor


Market Surveillance


• 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


Distributor


EU-MDR Article 22


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


Art. 22


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)]


Art. 22


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


Art. 22


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


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


Art. 22


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


Art. 22


Article 16


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


Art. 16


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


Art. 16


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


Art. 16


Questions

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