EU MDR (2017/745)

Labeling Remediation and

Compliance

WHITEPAPER
TABLE OF CONTENTS
Abstract 3

Abbreviations 4

MDR Change Summary 5

Impact Analysis 7

Impact on Labeling 10

What is a Label 10

Types of Labels 10

EU-MDR Labeling Requirements 11

Market Trends and Challenges 14

EU-MDR-Labeling Remediation Process 15

Best Practices 16

Conclusion 16

Author Info 17

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE

Abstract
The new European Medical Device Regulation (EU-MDR) 2017/745 and In Vitro Diagnostic Regu-
lations (IVDR) 2017/746 published by the EU Commision on its official journal on the 5th of May,
2017, are intended for the medical devices sold in the European single market for patient safety.
The new MDR is replacing the existing MDD 93/42/EEC (Medical Device Directive) and AIMDD
90/385/EEC (Active Implantable Medical Devices).

The manufacturers, having a European presence, need to invest time and material to update their
QMS and all levels of process in their regular operations. As of today, these manufacturers might
have started with the prioritization of products to perform gap assessment and remediation. Any
further delay may significantly impact their business, adding risk to their product(s) in the market.

The big list of new labeling requirements are challenging the manufacturers’ competence to
manage and implement these changes to meet compliance requirements within the limited
time frame. Similar to the US Food and Drug Administration (FDA), the EU MDR regulation is
also endorsing unique device identifiers (UDIs) and the European database on medical devices
(EUDAMED). It is important to understand that support and involvement from various quarters
are required to fulfill the UDI and EUDAMED implementation.

In this paper, we will emphasize on the overview of labelling changes and HCL’s distinctive remedi-
ation approach to meet the EU-MDR compliance.

CFDMDR
EU BASED
(2017/745)
TEMPERATURE
LABELING
PREDICTION
REMEDIATION
OF AAND
SHEET
COMPLIANCE
OF PAPER IN A PRINTER 3
Abbreviations
[Link]. Abbreviations Definition

1 AIMDD Active Implantable Medical Devices

2 CER Clinical Evaluation Report

3 CMR Carcinogenic Mutagenic Reprotoxic Substances

4 CS Common Specifications

5 EC European Council

6 EO Economic Operators

7 EUDAMED European Databank on Medical Devices

8 FSCA Field Safety Corrective Action

9 GSPR General Safety and Performance Requirements

10 IVDR In Vitro Diagnostic Medical Devices

11 MDCG Medical Device Coordination Group

12 MDD Medical Device Directive

13 MQMS Medical Quality Management System

14 NB Notified Bodies

15 PMCF Post-market Clinical Follow-up

16 PMS Post Market Surveillance

17 UDI Unique Device Identifier

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 4

5
MDR Change
Summary
Scope

The European Medical Device Regulation is setting up new rules regarding market positioning,
availability, and the service of medical devices and accessories for human use in the EU. These
regulations have more stringent requirements for clinical investigations on medical devices
conducted in the EU region, UDI implementation, and post-market survilance.

Objective

To ensure high standards of quality and safety for medical devices, high-level health protection
and patient safety are key focus areas.

The Medical Device Coordination Group (MDCG) attempted to harmonize the standards and
guidance across the EU.

Transition Period

The three-year transition timer started from May 2017, aiming for complete implementation in
May 2020. The existing MDD certificates are still valid. Also the notified agency’s reissued MDD
certificates are valid for five years and no later than 2024. Along with the certification timeline,
the MDR regulation has other important timelines for the EUDAMED and UDI implementation
milestones as shown below:

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 5

Key Changes

The all new EU-MDR is different in many aspects from the current MDD and AIMDD. Compared
to MDD, the new regulation introduced over 100 articles and five additional annexes. There are
new definitions, rules, procedures, and requirements being covered in these new sections.

MDD Vs MDR
60 Pages 175 Pages

20 Articles 123 Articles

12 Annexes 17 Annexes

The regulation will have significant changes which is forcing medical device businesses to review
their MQMS, design documents, templates, procedures, and overall process.

The key changes are categorized as follows:

Scope Expansion Identification & Vigilance Risk Management CER & PMCF
& Device Traceability &
classification (UDI & Post Market
EUDAMED) Surveillance

The label is an end product in the overall EU-MDR implementation cycle. The information needs
to be derived from various work [Link] organizations need to set the priority for the work
streams to start with remediation and pass the information to labeling.

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 6

Impact Analysis
The following are high-level summative points of the EU-MDR impact assessment:

MDR device classification changes

The classification criteria under annex VIII in the new EU-MDR provides the overview about device
classification principles. Reclassification of some medical devices and additional rules of classifica-
tion are described in this section. Due to the classification changes, all the manufacturers need to
reassess their device classification based on current changes.

All the devices are coming under categories per Chapter III – Classification Rules:
• Non-invasive Devices
• Invasive Devices
• Active Devices
• Special Rules

The rules further provide the details regarding device classification as follows:

Classification Risk Level Remarks

Low Risk Non sterile or do not have a measuring
Class I
function which are self certified devices.
Low/Medium Risk Sterile and/or have a measuring
function.
Reusable surgical instruments
Medium Risk Sterile use
Class IIa
Medium/High Risk Implantable devices
Class IIb
High Risk High risk and active implantable devices
Class III

Identification and Traceability

The unique device identification system is required for the traceability of devices, described
as mandatory in Chapter III, titled UDI and Databases. Along with this, the European Databank
on Medical Devices (EUDAMED) will be used to have a complete track of devices placed in the
European market. The tracking mechanism provides end-to-end traceability and identification
of medical devices during any incident reporting, recalls, or adverse events. This reflects the
intent of the Global Unique Device Identification Database (GUDID) as part of the UDI final rule
regulated by the US FDA during October 2013.

EUDAMED works as a repository accessed by the public and certain information is available only
for the specific stakeholders like EC, NB, CA, and EO.

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 7

Vigilance and Post-market Surveillance

The manufacturers are required to report a serious incident like death/unanticipated serious health
deterioration/serious public threat to the EU database within a specified timeline. Article 92 clarifies
that vigilance reporting and FSCAs (field safety corrective actions) are a part of the EUDAMED
system (European Databank on Medical Devices). Also the manufacturers need to produce a PSUR
(periodic safety update report) to the notified body. All this information are accessible to the public
and other stakeholders.

Risk Management

Under Annex I, Chapter I, the general requirements are listed down with some key points. It talks
about reducing the risks as far as possible without adversely affecting the benefit-risk ratio. Also the
manufacturer should establish, implement, document, and maintain the risk management system.
The manufacturer shall conform to safety principles, taking account of the generally acknowledged
state of art.

Conformity assessment activities with GSPR referred to Annex I and where applicable relevant
requirements of Annex II under the normal conditions of the intended use of the device shall be
based on clinical data providing sufficient clinical evidence.

Chapter II talks about requirements regarding design and manufacture. Devices/parts or materials
come in direct contact with the human body. So materials containing CMR, endocrine-disrupting
substances, and ohthalate substances measuring more than 0.1% in weight by weight (W/W)
would need to provide justification. Also, it should cover the mandatory information on the label,
packaging, and instructions for use (IFU).

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 8

 EU-MDR Labeling Residual Risk (Hazardous Substances,CER,PMS,PMCF & Risk File)

CER and Post-market Clinical Follow-up (PMCF)

Manufacturers need to establish and update a clinical evaluation plan and identify available clinical
data relevant to the device. The results of the clinical evaluation and clinical evidence on which it
is based should be documented in the clinical evaluation report supporting the assessment of the
conformity of the device.

PMCF is a continuous process to update the clinical evaluation referred in Part A of Annex XIV and
shall be part of the manufacturer's post-market surveillance plan.

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 9

Impact on Labeling
The labeling work seems to be challenging the manufacturers to plan their labeling operations to
accommodate the new EU-MDR requirements. The observation is that almost every packaging
level of label needs to undergo the complete remediation.

What is a Label?
Label means the written, printed, or graphic information appearing either on the device itself,
or on each packaging unit or multiple devices;

Types of Labels
Various types of labels are available based on the kind of packaging required for the medical
device. Each kind of labels have specific set of content requirements.
• Device label
• Unit label
• Pouch label
• Inner carton label
• Shipping carton label
• IFU
• Implant card
• e-IFU

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 10

All these labels should have information such as brand name of the device, manufacturer
address, batch number, lot number, quantity, frequency of use, unique device identifier, storage
conditions, general warnings, and precautions.

EU-MDR Labeling
Requirements
EU-MDR 2017/745 has laid out the following sections which clearly describes the labeling require-
ments and the mandatory information to be included in the labels. All devices should have infor-
mation to identify the device, manufacturer, and safety and performance guidelines. All these
information should be updated in the manufacturer’s website.

Annex I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

Chapter I General requirements
Chapter II Requirements regarding design and manufacture
Chapter III Requirements regarding the information supplied with the device
23 Label and instructions for use
23.1 General requirements regarding the information supplied by the
manufacturer
23.2 Information on the label
23.3 Information on the packaging which maintains the sterile condition of
a device (‘sterile packaging’)
23.4 Information in the instructions for use

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 11

There are several new requirements added now in comparison to the earlier MDD 93/42/EEC
and AIMDD. All the MDD compliant labels should undergo the detailed gap analysis to capture
the additional labeling content requirements.

23. Label and Instructions for Use

23.1. General • The information provided should be readily understood

requirements by the intended user.
regarding the • Device should be accompanied by the information
information supplied provided on the label. Where it is impractical, the
by the manufacturer information may appear on the packaging.
• Information should be updated on the company
website.
• Labels should be readable by human and machine
standards.
• Non-paper format (electronic format) might be
provided only under conditions set out in Regulation
(EU) No 207/2012.
• Residual risks should be communicated to the user.
• Internationally recognized symbols should be used. The
symbol or colour should be described properly if they
do not meet harmonized standards or CS.

23.2. Information on • Name and trade name of the device.

the label • The details strictly necessary for a user to identify the
device such as the contents of packaging and intended
purpose of the device.
• The name, registered tradename/symbol, and
registered address of business.
• An indication that the device contains medicinal
substance, human blood, or animal derivatives.
• Lot number or serial number or an equivalent
symbol(UDI Carrier).
• Time limit for using implanting device safely (at least
year and month).
• Indication of any special storage/handling condition
that is applicable.
• Minimum information of warnings or precautions which
needs immediate attention of user. More details should
be there in the IFU.
• Indication for single-use devices must be present.
• Indication for the reprocessing, number of reprocessing
cycles performed, and limitations should be provided
for the single-use device once applicable.
• The word ‘custom-made device’ should be
mentioned clearly for custom-made devices.
• Qualitative and quantitative information for
devices composed of substances introduced into
the human body via orifices and skin.
• Active implants should have a serial number and
other implants should have a serial number
or lot number.

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 12

 23.3. Information on • An indication of sterile packaging and decleration for
the packaging which the device is in a sterile condition.
maintains the sterile • The method of sterilization must be stated.
condition of a • Name and address of the manufacturer must be
device (‘sterile stated.
packaging’) • Description of device must be stated.
• The month and year of manufacture must be stated.
• Time limit for using implanting device safely (atleast
year and month) must be stated.
• An instruction to check IFU when the sterile package
is damaged must be stated.

23.4. Information in • Specifications of patient target group must be stated.

the instructions for • Expected clinical benefits, if applicable, must be stated.
use • Links to the summary of safety and clinical performance
must be stated for Class III and Implantable devices
• The performance characteristics of the device must be
stated.
• Information to verify if the device is suitable must be
stated and then select the corresponding software and
accessories must also be stated.
• Any residual risk, contra-indications and undesirable
side effects must be stated.
• Specifications for the user requires to use the device
appropriately must be stated.
• Details of any preparatory treatment or handling of
device must be stated.
• Any requirement for special facilities or special training
or particular qulaifications of device user must be
stated.
• Information needed to verify whether the device is
properly installed must be stated.
• Instruction in the event of the sterile packaging being
damaged must be stated.
• Sterilize before use instructions for the non sterile
products, if applicable, must be stated.
• Information on the appropriate process for reuse must
be stated. The validated method of re-sterilisation
appropriate to member states, wherever applicable,
must be stated. Also, the maximum number of allowable
reuses should be provided. The device can be reused
only if it is re-conditioned under the responsibility of the
manufacturer should be indicated.
• Information on any restrictions to combination of
devices and their identification must be stated.

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 13

Market Trends and
Challenges
Considering the overall EU-MDR framework, there are a lot of challenges involved for a medical
device manufacturer to place a medical equipment/device in the European market. The regulation
is expected to heavily impact the current quality management systems, data management, and
regulatory compliance of the medical industry. Several updates require a detailed level of analysis
and remediation by qualified resources.

At HCL, we understood these challenges and developed the implementation process of EU-MDR
for medical industry parteners to face it with greater resilience.

Reclassification of devices based on

new rules

GSPR & Conformity Assessments

Labelling (UDI & EUDAMED)

Clinical Evaluation, PMCF

Vigilance & Market surveilance

Risk Management File Annual update

Technical File updates

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 14

EU-MDR Labeling
Remediation
Process
The medical device industry is aware of the impact on medical device labeling due to the regulato-
ry change in EU region. Since HCL is a strategic partner with many medical device manufacturers
and has significant experience in handling similar regulatory compliance projects like the US FDA
UDI Implementation and GUDID Data Submission, HCL would like to emphasize and reinforce its
commitment to implement a successful business model under this regulation.

HCL understands the big picture and processes of the EU-MDR labeling remediation as shown
below:

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 15

Best Practices
1. HCL Technologies has developed many automation tools to reduce repetitive work like gap
assessments. These automation tools will ensure the reliability of data and also meet stringent
timelines.

2. There is a Center of Excellence (CoE) team created for the labeling work stream to ensure
reliable quality of deliverables to meet EU-MDR compliance requirements.

Conclusion
The new EU medical device regulation aims to improve patient safety and the current regulation
process among all the medical device manufacturers who are selling in Europe. HCL Technologies,
as one of the medical device service providers in the global market, is involved in many regulatory
compliance projects, providing end-to-end solutions to implement them on time. Since the new
regulation has hit the the overall QMS and technical documentation part, HCL did a comprehensive
investigation and prepared a QMS gap analysis, a comparative analysis, a process flow, check lists,
and overall transition plans. These cautionary efforts will definitely save time for customers and
provide adequate support to launch innovative and sustainable products in the market.

References
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation
(EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

[Link]
mdr-2017745

[Link]
medical-device-market-approval-and-certification/medical-device-regulation

[Link]
remediation-european-medical-device

[Link]

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 16

Author Info
Gopi Ganesh Chandra Sekaran
Gopi has a Bachelor’s degree in Polymer Technology. He has over 13 years of
experience in product design and development. He spent five years in the med-
ical devices domain. He has a wide experience in containers and disposable
medical products, quality system regulations, and has also handled regulatory
compliance projects like FDA-UDI, ISO-Luer, Test Method Validation, and
EU-MDR Labeling.

Mathiyazhagan Muthusamy
Mathiyazhagan has a Master’s degree in Applied Chemistry and Chemical
Engineering. He has over 27 years of experience. He spent 18 years in the med-
ical devices domain as quality head, R&D, quality management representative
for US FDA-QSR, ISO 13485, MDD (CE Mark), and is a certified lead auditor for
quality management systems. He is currently working in an engagement for a
large medical devices OEM across quality, design control, manufacturing, and
sustaining services areas.

EU MDR (2017/745) LABELING REMEDIATION AND COMPLIANCE 17

 ABOUT HCL TECHNOLOGIES
HCL Technologies (HCL) is a leading global IT services company that helps
global enterprises re–imagine and transform their businesses through digital
technology transformation. HCL operates out of 32 countries and has consolidated
revenues of US$ 6.97 billion, for 12 months ended 31st December, 2016. HCL
focuses on providing an integrated portfolio of services underlined by its Mode
1–2–3 growth strategy. Mode 1 encompasses the core services in the areas of
Applications, Infrastructure, BPO, and Engineering & R&D services, leveraging
DRYiCE™Autonomics to transform clients’ business and IT landscape, making
them ‘lean’ and ‘agile’. Mode 2 focuses on experience–centric and outcome–
oriented, services such as Digital and Analytics Services (BEYONDigital™), IoT
WorKS™, Cloud and Security, utilizing DRYiCE™ Orchestration to drive business
outcomes and enable enterprise digitalization. Mode 3 strategy is ecosystem–
driven, creating innovative

IP–partnerships to build products and platforms business.

HCL leverages its global network of integrated co-innovation labs, and global
delivery capabilities to provide holistic multi–service delivery in key industry
verticals including Financial Services, Manufacturing, Telecommunications,
Media, Publishing, Entertainment, Retail CPG, Life Sciences Healthcare, Oil &
Gas, Energy & Utilities, Travel, Transportation & Logistics and Government. With
120,000 professionals from diverse nationalities, HCL focuses on creating real
value for customers by taking ‘Relationships Beyond the Contract’. For more
information, please visit [Link].

ABOUT HCL ENTERPRISE

HCL is a $7.5 billion leading global technology and IT enterprise comprising two
companies listed in India – HCL Technologies and HCL Infosystems. Founded
in 1976, HCL is one of India’s original IT garage start-ups. A pioneer of modern
computing, HCL is a global transformational enterprise today. Its range of

IT infrastructure services, IT hardware, systems integration, and distribution

of information and communications technology (ICT) products across a wide
range of focused industry verticals. The HCL team consists of over 120,000
ideapreneurs of diverse nationalities, who operate from 32 countries including
over

500 points of presence in India. HCL has partnerships with several leading global
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