Medical Devices Regulation (MDR) 2017/745 - Part II Placing devices on EU market

PLACING
DEVICESON
EUMARKET
PAGE 1

PLACING ON THE MARKET
 General Safety and Performance Requirements (Annex I)
 Devices made available online must have EU Declaration of Conformity
 Demonstration of Conformity with relevant Harmonized Standards
 Common specifications can be adopted where no relevant harmonized standards exist
 Manufacturers not established in the EU must designate authorized representative
PAGE 2
A device may be placed on the market or put into service only if it complies with
this Regulation when duly supplied and properly installed, maintained and used in
accordance with its intended purpose.

DEVICES MANUFACTURED AND
USED IN HEALTH INSTITUTIONS
 In-house manufacture refers to medical
devices that are made in a healthcare
establishment to be used for patients
within that establishment.
 Comply with Annex I Requirements only
 Appropriate Quality Management
Systems
 Health institutions must document
manufacturing process, design and
performance of the device
PAGE 3

DISTANCE SALES
 This Regulation applies to device offered
online to customers within EU
 Applies to devices not placed on the
market but used in the context of
commercial activity
 Copy of EU declaration of Conformity
must be made available
 Enforcement ensured by Member States

CLAIMS
It is prohibited to mislead the user
with regard the device’s intended
purpose, safety and performance
 Functions the device does not have
 False impression regarding treatment,
diagnosis or purpose
 Failure to inform of risks
 Suggesting uses other than intended
purpose

HARMONIZED STANDARDS
 Devices that are in conformity with
relevant harmonized standards are
presumed to be in conformity with this
Regulation.
 Applies to system and process
requirements
 Includes European Pharmacopoeia
(surgical sutures, combination products)
PAGE 6

COMMON SPECIFICATIONS (CS)
The EC may adopt Common Specifications:
 general safety and performance requirements,
 technical documentation,
 clinical evaluation, PMCF
 clinical investigation
Devices in conformity with CS shall be presumed
to be in conformity with this Regulation.
Products listed in Annex XVI shall comply with
relevant CS for those products (devices w/o
medical purpose).
 Contact lenses, dermal fillers
 Equipment for liposuction
 High-intensity EM radiation
 equipment for brain stimulation

Manufacturing
processCompliance
RISK
MANAGEMENT
SYSTEM
Clinical
evaluation
Declaration
of Conformity
Technical
documentation
QUALITY
MANAGEMENT
SYSTEM
Keep Technical
Documentation
AUTHORIZED
REPRESENTATIVEUDI system Corrective
actions
Label in
local
language
POST-MARKET
SURVEILLANCE
Incident
reporting
system
Cooperate
with
Competent
Authorities
Compensation
for damage
Field
Safety
Corrective
Actions
When placing their devices on the market
or putting them into service
GENERAL OBLIGATIONS
OF MANUFACTURERES

GENERAL OBLIGATIONS
OF MANUFACTURERES
 Design and manufacture in compliance with this Regulation
 System for risk management (Section 3 of Annex I)
 Clinical evaluation, Post-Market Clinical Follow-Up (PMCF) (Article 61 and Annex XIV)
 Technical documentation to allow conformity assessment shall be available for 10 years
(Annexes II and III)
 Technical documentation for custom-made devices (Section 2 of Annex XIII)
 Declaration of Conformation, CE marking of conformity (Article 19 and 20)
 UDI system (Article 27, 29 and 31)
 Technical documentation available for competent authorities for 10 years (implantable devices
for 15 years)
 Authorized representative permanently available
List of General Obligations of Manufacturers(Article 10)

GENERAL OBLIGATIONS
OF MANUFACTURERES
 Procedures to ensure conformity with this Regulation
 Quality management system
 Post-market surveillance system (Article 83).
 Label in local language (Section 23 of Annex I)
 Obligation to implement corrective actions, withdraw or recall devices in case of non-
conformity
 System for recording and reporting incidents and field safety corrective actions
(Articles 87 and 88).
 Demonstrate device conformity upon request from Competent authorities
 Disclosure of legal or natural persons designated to manufacture devices
 Right to claim compensation for damage caused by a defective device

Manufacturers of devices other
than custom-made devices shall
draw up and keep up to date
technical documentation to
allow assessment of conformity
with this Regulation and
Annexes II and III.
Delegated acts expected.
Technical
Documentation
Manufacturers shall keep the
technical documentation, the
EU declaration of conformity
and certificates (Article 56),
available for competent
authorities at least 10 years
after the last device has been
placed on the market.
Implantable devices shall be
kept at least 15 years.
Availability of
technical
documentation
General Obligations of Manufacturers
TECHNICAL DOCUMENTATION

Statement for a patient or user
 Name and address of the manufacturer (all sites)
 Name and address of the authorized representative
 Data allowing identification of the device
 A statement that the device is intended for exclusive use
by a particular identifiable patient or user
 Prescribing health professional, incl. health institution
 Specific characteristics of the product
 Conformity statement
 General safety and performance requirements
 Medicinal substances incorporated in the device
 Keep 10 years (implantable 15 years)
General requirements
Manufacturers shall draw up, keep up to date
and keep documentation available for
conformity assessment
Surveillance
The manufacturer shall review, and document
experience gained in the post-production phase,
including Post-Market Clinical Follow-Up and
implement appropriate corrective action
Reporting obligations
 Serious incidents
 Field safety corrective actions
CUSTOM-MADE DEVICES

• Continuous process throughout the entire
lifecycle of a device
• Regular systematic updating
• Establish and document a risk management
plan for each device
• Identify and analyze the known and
foreseeable hazards
• Evaluate risks associated with intended use
and reasonably foreseeable misuse
 Eliminate or control the risks
Manufacturers shall establish, implement, document and maintain a risk management system.
Evaluate the impact of information
from post-market surveillance
• Occurrence and frequency
of hazards, associated risks
• Overall risk, benefit-risk
ratio and risk acceptability
 Amend control measures
RISK MANAGEMENT SYSTEM
Annex I

Manufacturers shall establish, implement, document
and maintain a risk management system.
Risk control measures
 Shall conform to generally acknowledged state of the art safety
principles
 Residual risk associated with each hazard must be acceptable
 Overall residual risk must be judged as acceptable.
Annex I

Appropriate solutions:
1. Safe design and manufacture
2. Adequate protection measures such as alarms
3. Safety warnings, precautions, contra-indications
4. Training to users
Inform users of any residual risks
Manufacturers shall establish, implement, document and maintain a risk management system.
Annex I

USE ERROR
To eliminate/reduce risks related to use error, manufacturer shall:
• Adjust ergonomic features of the device
• Adjust environment to improve patient safety
• Consider user’s technical knowledge, experience, education,
training, use environment, and the medical and physical
conditions of intended users (i.e. layperson, disabled)
Manufacturers shall establish, implement, document
and maintain a risk management system.
Annex I

• Manufacturers shall have procedures to ensure
conformity of devices
• Changes in device design or harmonized
standards shall be addressed in a timely manner.
• QMS shall cover structure, responsibilities,
procedures, processes and management
resources required to ensure compliance
QUALITY MANAGEMENT SYSTEM
Manufacturers of devices shall establish, document,
implement, maintain, keep up to date and continually
improve a quality management system to ensure
compliance with this Regulation proportionately to the
risk class and type of device.
Annex I

The quality management system shall address:
 strategy for regulatory compliance
 identification of applicable requirements and
exploration of options how to address them
 responsibility of the management
 resource management
 control of suppliers and sub-contractors
 risk management
 clinical evaluation and PMCF
QUALITY MANAGEMENT SYSTEM
 product realization, incl. planning, design,
development, production and service provision
 verification of UDI assignments
 post-market surveillance system
 handling communication
 serious incidents, field safety corrective actions
 corrective and preventive actions
 product improvement.

AUTHORIZED REPRESENTATIVE
 Verify EU Declaration of Conformity and
technical documentation
 Keep copy of technical documentation
 Comply with registration obligations
 Provide documents to Competent
Authorities
 Cooperate on any CAPAs and FSCAs
 Legal liability for defective devices
 Procedures for change of AR

GENERAL OBLIGATIONS OF
IMPORTERS
• Ensure Conformity
• Authorized representative
• List the device in electronic registry
• Device described and labelled
• CE marking
• Declaration of Conformity
• UDI
• Forward incidents to manufacturer
• Registry of complaints

GENERAL OBLIGATIONS OF
DISTRIBUTORS
 Device properly described and labelled
 CE marking
 Declaration of Conformity
 UDI
 Forward incidents to manufacturer
 Registry of complaints
 Information supplied by the
manufacturer
 Storage and transport conditions
 CAPAs, FSCAs, recalls, withdrawals

PERSON RESPONSIBLE FOR REGULATORY
COMPLIANCE
 Manufacturers and Authorized
Representatives must have Responsible
Person at their disposal at all times
 Qualifications:
 science degree + 1-year professional
experience or 4 years experience
 RP ensures compliance with
 conformity requirements,
 technical documentation updates,
 Post-market surveillance obligations,
 Reporting obligations
PAGE 22

CASES WHEN OBLIGATIONS OF
MANUFACTURERS APPLY TO
IMPORTERS AND DISTRIBUTORS
 Devices made available under the
name of importer/distributor
 Changes the intended purpose or
modifies device placed on the market
 Quality management of translation of
labeling and packaging/repackaging
 Notification of intent to make a
relabeled/repackaged device
available required 28 days before
launch

SINGLE-USE DEVICES
 Reprocessing is only allowed when
permitted by national law
 Devices reprocessed in hospitals must be
equivalent to original device or in
compliance with common specifications
PAGE 24

IMPLANT CARDS
 Device identification, serial #, lot #,
UDI, model, manufacturer’s details
 Warnings, precautions or measures
to be taken (MRI, CT, X-rays etc.)
 Expected lifetime and follow-up
 Information to ensure safe use of
the device understandable to a lay
person
 Updates available online
 Patient’s identity
Exemptions:
Sutures, staples, dental fillings, dental
braces, tooth crowns, screws, wedges,
plates, wires, pins, clips and connectors.

 Manufacturer shall continuously
update Declaration of Conformity
 Single EU DoC, national languages
 Details in Annex IV
EU DECLARATION OF
CONFORMITY

EU Declaration of Conformity
 Name, registered trade name or registered trademark
 Authorized representative
 Manufacturer’s business address and Single Registration Identifier (SRN)
 Statement that EU declaration of conformity is issued under the responsibility of the manufacturer
 Basic UDI-DI (Part C of Annex VI)
 Unambiguous reference to the device (i.e. name, code, catalogue #) allowing traceability
 Intended purpose
 Risk class (Annex VIII)
 References to any Common Specifications to which conformity is declared
 Identification of the notified body, conformity assessment procedure,
 Identification of the certificate(s) issued
 Place and date of issue of the declaration, name and signature
PAGE 27
Article 19, Annex IV

 Devices considered to be in conformity
with the requirements of this Regulation
 Before placing on the market
 Visible, legible and indelible
 Affixed to sterile packaging, instructions for
use and sales packaging
 Pictograms indicating a special risk
 Notified body responsible for the
conformity assessment procedures
 Promotional materials which mention that
a device has CE marking
CE MARKING

DEVICES FOR SPECIAL
PURPOSES
Member States shall not create obstacles:
• Supply of investigational devices to
investigators
• Making available custom-made devices
compliant with Annex XIII
• Devices w/o CE marking at exhibitions,
trade shows and demonstrations

SYSTEMS AND PROCEDURE PACKS
 Any natural or legal person can combine
devices in a procedure pack
 Combine devices and in vitro devices
with CE marking and other products
 Statement: mutual compatibility,
information provided by manufacturer(s)
 Subject to internal monitoring
 Sterilized packs subject to Annex IX or
Part A of Annex XI
 Devices w/o CE marking require
conformity assessment
 Additional CE marking not required
PAGE 30

SPARE PARTS
 Any natural or legal person can make
and sell spare parts to replace an
identical or similar part of a device
 The item does not adversely affect the
safety and performance of the device.
 Keep supporting evidence
 A repaired device must be in
conformation with this Regulation
PAGE 31

FREE MOVEMENT
Member States shall not refuse,
prohibit or restrict sale of compliant
devices within their territory

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