Slide 1

A Regulation of the European Parliament and of the Council on [/in vitrodiagnostic] medical devices (approved by EP on 5 April 2017; published 5 May 2017 in the Official Journal of the EU; date of application 26 May 2020):

Whereas: (41/38) The traceability of devices by means of a Unique Device Identification (UDI) system … should significantly enhance the effectiveness of the post-market safety-related activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against falsified devices. Use of the UDI system should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators and, where possible, be compatible with other authentication systems already in place in those settings.

Slide 2

The US and EU MDR/IVDRUDI Requirements

Similarities, Differences and Implementation Issues

5 December 2017

Jay CrowleyVice President & Practice Lead – UDI Services and Solutions

USDM Life Sciences

Slide 3

Agenda• The History and Development of the US UDI System• Overview of the EU MDR and IVDR UDI Regulations• The EU UDI System• Similarities and Differences with the US UDI Regulation• Summary• Q&A

Slide 4

US Legislation (FDAAA 07; FDASIA 12)Not later than December 31, 2012, the Secretary shall issue proposed regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number. The Secretary shall finalize the proposed regulations not later than 6 months after the close of the comment period and shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies.

Slide 5

Public Health BenefitsUDI and GUDID provides global visibility and supports:• Medical device recalls• Adverse event reporting• Tracking and tracing• Supply chain security• Anti-counterfeiting/diversion• Disaster/terror preparation• Shortages/substitutions• Reduction of medical errors (e.g., bedside scanning)• An accessible source of device information for patients & clinicians

Slide 6

National Medical Device Postmarket Surveillance Plan

Slide 7

Phased-In US Compliance DatesImplementation (compliance) timeframes – September 24:• 2014: class III and devices licensed under PHS Act• 2015: class II/I implants and life-supporting/sustaining• 2016: rest of class II• 2016: Non-sterile implants• 2018: class I [enforcement discretion to 2020]

For Direct Marking:• Compliance dates are extended by 2 years• except for FDASIA (year 2) devices – still at year 2.

Slide 8

IMDRF Guidance – Goal Largely Realized

Slide 9

The Evolving UDI Global Landscape

US UDI

EUMDR

UKNHS

RegulatoryRequirements

“Commercial” or (Ministry of) Health/Cost/Import Control RequirementsQatar (all devices)Denmark (implants)

In the US – Also IDNs (Kaiser); GPOsONC/EHRs, CMS

South Korea – 2019-2022India – 2022Saudi Arabia – ~2018-

2020Taiwan – ~2018-2020Canada – “IMDRF”?China – any day…?Singapore – coming…

Traceability Requirements

Slide 10

Benefits/Needs of the EU UDI SystemThe EU Unique Device Identification (UDI) System will:1. Provide for the traceability of devices 2. Enhance the effectiveness of post-market safety-related activities 3. Improve incident reporting4. Provide for targeted field safety corrective actions 5. Provide for better monitoring by competent authorities6. Reduce medical errors 7. Fight against falsified devices8. Improve purchasing, waste disposal policies and stock-management by

health institutions

Slide 11

Before placing a device on the market…NEW PROCESS: Before the first making available of a device…1.Manufacturers, authorized representatives and importers submit

information (Annex VI, Part A, Section 1) – and keep updated2.The competent authority provides a single registration number (SRN) –

used when applying to a NB and for accessing Eudamed3.MNF assigns a Basic UDI-DI (BUDI) to the device4.MNF enters/verifies the BUDI and device registration information (Annex

VI, Part A, Section 2) – and keeps updated5.MNF assigns UDI-DI(s) to the device and (higher levels) packaging6.MNF provides the BUDI, UDI-DI(s), SRN and core data elements to the

UDI database (Annex VI, Part B) – and keeps updated7.UDI carriers placed on device label and higher levels of packaging

Slide 12

Placing Devices on EU Market

Obtain a Single

Registration NumberFrom the

competentauthorityArticle 25Annex VPart A

section 1

Registration of Medical

Devicesin EUDAMEDArticle 24b

(3a)Annex V

Part 1 section 2

Register in the Electronic

UDIDatabase

Article 24aAnnex V

Part B

Obtain a UDI from an

assigningentities

Article 24§2+

Article 94§9

Obtain the certificatefrom the

notified boby(If required

according to the class of the medical

device)

Place the Medical

Device on the Market

STEP 1 STEP 5STEP 4STEP 3STEP 2 STEP 6

Slide 13

Overview of UDIAssign Device Identifier (DI)

to devices and packages

Utilize appropriate Production Identifier(s) (PIs)

Place the UDI (DI+PI) carrier on the Label and Package

Send UDI-DI and core date elements to UDI Database

Collect, store, verify datafor the UDI database

Assess changes for new DI or new/updated data

Work w/Issuing agency(GS1, AISBL, HIBCC, ICCBBA)

The UDI DatabaseStore the UDI internally

Distribute UDIcompliant devices

Slide 14

Overview of MDR/IVDR UDI RegulationsArticle 10 General obligations of manufacturers• 7[/6]. Manufacturers shall comply with the obligations relating to the UDI

system referred to in Article 27[/24] and with the registration obligations referred to in Articles 29[/26] and 31[/28].

• 9[/8]. The quality management system shall address at least the following aspects: (h) verification of the UDI assignments made in accordance with Article 27[/24](3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29[/26].

Slide 15

Overview of MDR/IVDR UDI Regulations• Article 27[/24] Unique Device Identification system• Article 28[/25] UDI database• Article 29[/26] Registration of devices• Article 33[/30] European database on medical devices – including UDID• Article 87[/82] Reporting of serious incidents and field safety corrective

actions (Article 27[/24]-5 The UDI shall be used for reporting serious incidents and field safety corrective actions)

• Article 92[/87] Electronic system on vigilance and on post-market surveillance – “That electronic system shall include relevant links to the UDI database.”

Slide 16

Overview of MDR/IVDR UDI RegulationsArticle 13 General obligations of importers• 2. In order to place a device on the market, importers shall verify that:

(d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27[/24].

Article 14 General obligations of distributors• 2. Before making a device available on the market, distributors shall

verify that: (d) where applicable, a UDI has been assigned by the manufacturer.

Slide 17

Overview of MDR/IVDR UDI RegulationsArticle 18 [MDR only] Implant card and information to be supplied to the patient with an implanted device• 1. The manufacturer of an implantable device shall provide together

with the device the following:– (a) information allowing the identification of the device, including the

device name, …. the UDI, … as well as the name, address and…

• In addition, the manufacturer shall provide the information referred to in point (a) … on an implant card delivered with the device.

Slide 18

Overview of MDR/IVDR UDI Regulations• Annex VI – Part A: Information to be submitted upon the registration of

devices and economic operators in accordance with articles 29(4)[/26(3)] and 31[/28] (Basic UDI-DI)

• Annex VI – Part B: Core data elements to be provided to the UDI database together with the UDI-DI in accordance with articles 28[/25] and 29[/26]

• Annex VI – Part C: The UDI System• 2.1. The affixing of the UDI is an additional requirement – it does not

replace any other marking or labelling requirements laid down in Annex I to this Regulation.

Slide 19

Basic UDI-DI“…is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU DoCs.”• Article 27[/24], 29[/26]• Article 32[/29] Summary of safety and clinical performance• Article 60[/55] Certificate of free sale• Annex II Technical documentation• annex IV EU declaration of conformity (DoCs)• Annex VI Parts A and B• Annex XII Certificates issued by a notified body

Slide 20

Classification Changes• For example: spinal, joints to Class III; reusable surgical instruments

from class I to Class IIa• Annex XV – products with no Medical Purpose regulated as devices

(e.g., contact lenses, liposuction) • Products specifically intended for the cleaning, disinfection or

sterilization of medical devices are considered medical devices• Devices for the purpose of control or support of conception shall be

considered medical devices• Significant IVD classification changes

Slide 21

The EU UDI System• The UDI system shall allow the identification and facilitate the

traceability of devices.• “The label shall bear … (h[/g]) the UDI Carrier …• UDI – UDI-DI (Device Identifier – specific to a model) + UDI-PI

(Production Identifier(s) – include lot, serial number, software identification or expiration date); manufacturing date if only PI.

• UDI assigned to device itself or its package.• Developed using global standard (e.g., GS1, HIBCC, ICCBBA)• The UDI-DI shall be unique at each level of device packaging.• Accessories are considered devices and subject to UDI.

Slide 22

The UDI Carrier• The UDI Carrier (Annex VI, Part C) “…is the means of conveying the

UDI by using AIDC and, if applicable, its HRI.”• The UDI carrier shall be placed on the label or on the device itself and

on all higher levels of device packaging.• The HRI format shall follow the rules of the … issuing entity.• The DI and PI may be concatenated or non-concatenated.• If the manufacturer is using RFID … a linear or 2D bar code … shall

also be provided on the label.• The UDI carrier (label and DM) shall be readable during normal use and

throughout the intended lifetime of the device.

Slide 23

The UDI Carrier is technology neutral…BUT – Article 27[/24] states:

– When designating issuing entities, the Commission shall endeavor to ensure that UDI carriers, as defined in Part C of Annex VI, are universally readable regardless of the system used by the issuing entity, with a view to minimizing financial and administrative burdens for economic operators, health institutions and healthcare professionals.

Slide 24

Direct Marking• Devices that are reusable shall bear a UDI carrier (AIDC and HRI

representation of the UDI) on the device itself.• The UDI carrier for reusable devices that require cleaning, disinfection,

sterilization or refurbishing between patient uses:• shall be permanent• must be readable throughout the device’s intended lifetime

• This shall not apply to devices when the direct marking:– (a) would interfere with the safety or performance;– (b) is not technologically feasible.

EU UDI SYSTEM

Slide 25

Exceptions• Custom + investigational [/performance studies] devices exempt.• Devices for retail/POS do not require PIs in AIDC on POS UDI label.• Individual class I and IIa [/class A and B] SUDs do not require the UDI

Carrier – UDI can be on a higher level of packaging.• If there are significant space constraints (???):

• on the unit of use packaging – the UDI carrier may be placed on the next higher packaging level.

• limiting both AIDC and HRI on the label – only AIDC is required.– However, for devices intended for e.g., home care, the HRI must be on

the label – even if then there is no space for the AIDC.

Slide 26

Shipping Containers• “… a container in relation to which traceability is controlled by a

process specific to logistics systems” are exempt.• US - a container used during the shipment or transportation of devices,

and whose contents may vary from one shipment to another.

• By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices … and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.

Slide 27

Systems, Configurable Devices, Packs/KitsA separate UDI must be on a:• System (products combined to achieve a medical purpose),• Configurable device (device consisting of several components),• Procedural pack (products packaged for a medical purpose), and• IVD kit (products packaged together to perform an IVD exam).

A UDI must ALSO be on the individual devices/packages or componentsof a system, configurable device or procedure pack [NOT IVD kit], except:

• SUDs which are not intended for use outside the system/pack, or• Devices that are (already) exempt are not subject when included.

Slide 28

Configurable Device vs System• Configurable device – is a device that consists of several components

[undefined?] which can be assembled by the manufacturer in multiple configurations.

• System – means a combination of products [undefined?], either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose.

Slide 29

A Configurable Device is a DEVICE• Only called out specifically in Annex VI (PART C The UDI System)• Configurable device UDI assigned to the entire configurable device• Configurable device UDI-DI assigned to groups of configurations –

which is the collection of possible configurations• The configurable device UDI carrier must be on the assembly that is

most unlikely to be exchanged during the lifetime of the system.• Individual components may be [???] devices in themselves• A component commercially available on its own needs its own UDI• Include CT systems, ultrasound systems, anaesthesia systems,

physiological Monitoring systems, etc.

Slide 30

A System is a “combination of products”Natural/legal person:• Must verify the mutual compatibility and develop statement if they intend

to combine CE marked device with other CE marked devices, IVDs, or other conforming products –compatible with the intended purpose and use specified by their manufacturers

• Becomes the manufacturer of the “system” (then a device in its own right) if it incorporates non-CE marked devices or uses not compatible with the original intended purpose.

• Responsible for identifying the system with UDI-DI and UDI-PI.

Slide 31

A New UDI-DIA new UDI-DI is required when there is a change:• That could lead to misidentification of the device and/or ambiguity in its

traceability.• In the UDI Database for information in fields: Brand Name or Trade

name; Device version or model; Labelled as single use; Packaged sterile; Need for sterilization before use; Quantity of devices provided in a package; or Critical warnings or contraindications.

• For software, whenever there is a modification that affects the original performance and effectiveness; the safety or the intended use; or interpretation of data.

Slide 32

Additional RequirementsFor Implantable Devices:• The lowest level of packaging shall be marked with a UDI.• Active implantable devices must have a serial number.• The device’s UDI must be identifiable prior to implantation.• An implant card, including its UDI, must be provided with device.For Software (as a Medical Device – SaMD):• That is a device and separately distributed must have its own UDI.• The UDI is assigned at the system level.• The label (AIDC and HRI) and software UDI must be identical.• The UDI must be in HRI on readily accessible (e.g., about) screen.

Slide 33

Borderline (“Combination) ProductsA medical (borderline/“combination”) product is subject to the MDR – and therefore UDI – if the device:• Incorporates as an integral part an IVD medical device [MDR].• Incorporates a medicinal product … including a product derived from

human blood or plasma … with action ancillary to the device [PMOA device].

• Is intended to administer gene therapy medicinal products.• Incorporates tissues or cells of human origin or their derivatives with

action ancillary to the device [PMOA device].

Slide 34

Except…A borderline (“combination”) medical product is subject to the applicable non-device directive/regulation :• If the action of the medicinal substance is principal, not ancillary to that

of the device [PMOA drug]. • If the device is intended to administer a medicinal product and it forms a

single integral product which is intended exclusively for use in the given combination and which is not reusable [single entity CP]

• If the action of the tissues or cells or their derivatives is principal, not ancillary to that of the device and the product is not governed by the advanced therapy medicinal products [PMOA biologic].

Slide 35

The EU UDI Database• Annex VI, Part B lists the ~22 mandatory + optional data elements.• The UDI-DI and core data elements are only about the device – no

specific production identifiers (PIs) are collected.• The database should not contain commercial confidential data.• The data must be validated and periodically reconfirmed.• Data for a new UDI-DI must be entered before the device is placed on

the market.• If changes do NOT require a new UDI-DI, record must be updated within

30 days.

Slide 36

Obligations of Responsible Parties• The manufacturer [the person who manufactures … or has a device

designed, manufactured … and markets that device under his name] is responsible for UDI assignment and the UDI database.

• A distributor/importer…assumes the obligations of a manufacturer if he markets a device under his name…except when an agreement states the manufacturer is identified (on label) and is responsible.

• A person who reprocesses a SUD is considered the (re-) manufacturer of the SUD; assumes the traceability obligations.

• Manufacturers, authorized representatives, or importers must ensure the UDI-DI in the registration system is complete, correct and updated…

Slide 37

TraceabilityEconomic operators (the manufacturer, authorized representative, importer, distributor, and system or procedure pack producers or sterilizers) must keep (preferably by electronic means), the UDI of these devices that they have BOTH supplied and been supplied with:

• Class III implantable devices, and• Other devices the EC adopts through delegated acts.

Health institutions must keep (preferably by electronic means) UDI of:• Class III implantable devices, and• Others devices added by member states.

Slide 38

Implementation – UDI DatabaseDate of Application: for MDR – 26 May 2020; for IVDR 26 May 2022

Article 29(1{2})[/26(1)] Registration of devices – due the later of the date of application or 6 months after publication of notice in Article 34(3):• Before placing a device {,system or procedure pack} … on the market,

the manufacturer shall … assign a Basic UDI-DI … and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI…

Slide 39

Implementation – Label and PackagesThe UDI carrier must be placed on the label of the device and on all higher levels of packaging:• For implantable and Class III devices/class D IVDs: 26 May 2021/2023• For Class IIa/IIb devices/class B/C IVDs: 26 May 2023/2025• For Class I devices/Class A IVDs: 26 May 2025/2027

For reusable devices that require UDI Carrier on the device itself:• 2 years after the applicable class compliance date.

Slide 40

Implementation – Priority ListThe seven priority areas are:1. Clinical Evaluation & Clinical Investigation (MD); Performance

Evaluation & Performance Studies (IVD)2. Scope & Classification3. Notified Bodies & Conformity Assessment4. Post-Market Surveillance & Vigilance for both MD and IVD5. Eudamed & UDI6. Market Surveillance7. IVD-specific Issues

Slide 41

Implementation – Priority for CAs

Slide 42

Implementation – Priority for CAs

Slide 43

Accessories (vs service/spare parts)US: accessories… support, supplement, and/or augment the performance of a parent device…

EU: Article 2(2) ‘accessory for a medical device’ means an article which … is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s)

Slide 44

EU definition “The manufacturer is any natural or legal person who is responsible for designing and manufacturing a product with a view to placing it on the Community market "under his own name" (or trademark).”

US: “Labeler” is any person who causes a label to be:• applied to a device with the intent that the device will be

commercially distributed; or • replaced or modified with the intent that the device will be

commercially distributed.

Who is the “Labeler”?

Slide 45

Barcode Verification is…• Verification: A technical measurement process to confirm that a

barcode conforms to the applicable ISO symbol specifications.

• Verifier: The tool used to make technical measurements.o Measures the symbols vs. standardso Calculates a Grade for the symbolo Creates an Assessment Reporto Minimum grade is usually ‘C’ or better

Figure from: GS1 2D Barcode Verification Process, Issue 1.3.21, Final, June 2014

Slide 46

The label* of EVERY medical device (including all IVDs) must have a UDI.

* Section 201(k) defines 'label' as a display of written, printed, or graphic matter upon the immediate container of any article...

US UDI General Rule #1

Slide 47

• On 19 November 2014 – FDA extended the labeling requirements compliance date for most non-sterile implants from 2015 to 2016

• “Most of the devices that meet these … criteria are supplied non-sterile by the manufacturer” and are “intended to be sterilized (or cleaned and sterilized) before use.”

• “FDA is initiating this extension to allow time for the development and implementation of an alternative that would provide for more accurate and precise device identification than the requirements of 21 CFR 801 subpart B.”

US Non-Sterile Implant Extension

Slide 48

EU Implantable devices• 6.1.1. Implantable devices shall, at their lowest level of packaging (‘unit

packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI)

• 6.1.2. The UDI-PI shall have at least the following characteristics: (a) the serial number for active implantable devices, (b) the serial number or lot number for other implantable devices.

• 6.1.3. The UDI of the implantable device shall be identifiable prior to implantation.

Slide 49

• Almost all class I devices exempt from premarket requirements.• Consequently, often significant ambiguity about whether

device/accessory is a regulated medical product.• Procodes (self-assigned) may not be current/relevant• Listing number needed for GUDID entry – so R&L must also be

current.• Many downstream users will expect full UDI (DI and PIs).

“Unique” US Class I Issues

Slide 50

SUD packaging exception EU: … classes I and IIa SUDs packaged and labelled individually … • However, when the healthcare provider is not expected to have access

… to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.

US: not on the individual SUDs – given that the devices are:• all of a single version or model,• not implantable devices,• distributed together in a single device package,• intended to be stored in that device package until removed for use, and• which are not intended for individual commercial distribution.

Slide 51

Implementation – US UDI Similarities (1/2)• As in the US, largely based on GHTF + IMDRF UDI guidances• UDI assigned/marked with AIDC+HRI on device labels & packages• Use of global Issuing Agencies (GS1, HIBCC, ICCBBA)• UDI for accessories, systems (and configurable devices), and procedure

packs/convenience kits• “Combination products” – if regulated as device – needs UDI• UDI for SaS/SaMD in embedded screen and label/physical media• Shipping containers, custom and investigational devices – exempt• PIs (generally) not specified• Retail/POS do not require PIs in UDI (US class I, others by request).

Slide 52

Implementation – US UDI Similarities (2/2)• Technology neutral approach (no specific AIDC required)• Reusable devices need “direct mark” (permanent) UDI on device• UDI for implants MUST be identifiable prior to implantation.• UDI Database – submit (static) core data attributes for each device• Data for a new UDI-DI must be entered before the device is placed on

the market; other changes within 30 days.• New UDI-DI is required when there is a change to the device or in

certain UDI Database fields• Barcode verification

Slide 53

Implementation – US UDI Differences (1/2)• Responsibility: US Labeler vs EU Manufacturer• SUD packaging exception: EU limited to class I/IIa [/class A/B] – also,

less restrictions (SUD and individually labeled and packaged)• Procedure packs (aka “convenience kits”) and Systems: EU individual

devices must ALSO be UDI compliant – unless SUD or already exempted

• Configurable device: EU UDI on separately distributed components• IVD Kits: EU UDI ALSO for individually distributed reagents and articles

(but not parts of kit)• Standardized date format (YYYY-MM-DD): EU not required

Slide 54

Implementation – US UDI Differences (2/2)• Software: EU label and software UDI must be identical• Class I devices: EU needs both DI and PI• DM UDI: EU UDI must be both AIDC and HRI• Direct Mark: EU does NOT exempt devices that are only cleaned

between different patient use and single patient use.• “Existing inventory” exemption: EU does not have

Slide 55

Implementation – Database Similarities US GUDID EU Eudamed

1 Primary DI number (and issuing agency)

UDI-DI

2 Labeler company name and physical address (as represented by labeler DUNS)

Name and address of the manufacturer (as on the label),

3 Brand name Name or trade name (optional) 4 Version or model Device model, reference, or catalogue

number (optional) 5 Catalog number (optional) 6 Device description (optional) Additional product description

(optional) 7 Clinically relevant size (size type, size

value, and size unit of measure – or size type text)

Clinical size – including volume, length, gauge, diameter (optional)

8 Production identifier(s) – lot or batch number, manufacturing date, serial number, expiration date, and/or donation identification number

Manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number)

9 For single-use (y/n) Labelled as a single-use device (y/n) 10 Device packaged as sterile (y/n) Device labelled sterile (y/n) 11 Requires sterilization prior to use (y/n) Need for sterilisation before use (y/n) 12 Device labeled as containing natural

rubber latex or dry natural rubber (y/n) Containing latex (y/n)

13 Storage and handling (type, low value, high value, and unit of measure)

Storage and/or handling conditions – as indicated on the label or in the instructions for use (optional)

14 Device Count (for primary DI) Quantity per package configuration 15 Package DI number

Quantity per package Contains DI package

16 Unit of use DI number The unit of use UDI-DI 17 DI record publish date

Commercial distribution end date Status of the device (on the market, no longer placed on the market

Slide 56

Implementation – Database DifferencesUnique US GUDID Attributes Unique EU Eudamed Attributes

Labeler DUNS Number (Company Name and Company Physical Address)

The Basic UDI-DI

Secondary DI Number (and Issuing Agency)

The Single Registration Number (SRN)

Device subject to direct marking DM), but exempt

If applicable, name and address of the authorised representative (as on the label)

DM DI different from primary DI (and DM DI number)

If applicable, additional trade names of the device

Customer Contact – phone and email Risk class of the device Prescription use (Rx) and/or Over the Counter (OTC)

The medical device nomenclature code as provided for in Article 26

Device is also a HCT/P, kit and/or combination product

If applicable, the maximum number of reuses

Premarket submission number (PMA, PMA supplement number, 510k, or device exempt)

Where applicable, information labelled in accordance with Section 10.4.5 of Annex I

FDA product code (auto-populates product code name)

URL for additional information, such as electronic instructions for use (optional)

FDA listing number If applicable, critical warnings or contra-indications

GMDN code (auto-populates name and definition)

Status – recalled, field safety corrective action initiated

Device labeled as "Not made with natural rubber latex"

MRI safety status (safe, unsafe, or conditional – or label does not contain)

Special storage conditions Sterilization method (specified list of values)

Package type

Slide 57

Implementation – Database TranslationsThese fields, which are common to GUDID and Eudamed, will most likely need to be translated into the 24 official languages of the EU:1. Name or trade name2. Additional product description3. Clinical size – including volume, length, gauge, diameter4. Storage and/or handling conditions – as indicated on label or IFU5. Additional trade names of the device6. Critical warnings or contra-indications

Slide 58

The future is fast approaching…

What you need to do…starting now…• Understand what devices you sell in the EU• Replace, remediate or retire• Develop strategy/program• Understand MDM approach• Start collecting and managing data for UDID

Turning back time is not an option…

Slide 59