CE Marking for Medical Devices
“Basic Steps to Compliance”
Ján Petrík, PhD.
EVPÚ, a.s. Nová Dubnica
Medical Devices Branch Office Bratislava
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Basic Steps to Compliance
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Determining Whether or Not the Product is
Within the Scope of the Directive
Classification
Conformity Assessment Routes
Compliance to the Essential Requirements of
the Directive
Harmonized Standards
Technical File
Risk Analysis
Notified Body
Authorized Representative and Competent Authority
- Registration
Vigilance System
CE Marking
Declaration of Conformity
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Within the Scope of the Directive?
•
Medical Device (MDD) 93/42/EEC
•
Active Implantable Medical Device (AIMD)
90/385/EEC
•
In-vitro Diagnostics (IVDD) 98/79/EC
The definition will determine the scope
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What are Medical Devices?
Medical devices are defined as all devices which
according to the manufacturer are intended to be used
in the treatment of humans, whether it concerns
diagnosing, monitoring, prevention, treatment or
alleviation.
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Classification
All medical devices must comply with all relevant
requirements of the Directive. Therefore the classification
only serves to determine which conformity assessment
procedure to apply and whether or not a notified body
must co-operate.
Annex IX
18 rules based on
- intended use
- duration of contact
- degree of invasiveness
- special situations
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Classification
The Directive divides the medical devices into four different
classes (I, IIa, IIb and III). In addition, class I is subdivided into
devices which are sold in a sterile condition and devices which are
sold with a measuring function.
The classification reflects the risks involved in the use of the
product, the vulnerability of the parts of the body on which the
devices are to be applied and the duration of use.
Classes
Class I
Class IIa
Classes IIb & III
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low risk
medium risk
high risk
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Classification
Duration of Contact
up to 60 minutes
up to 30 days
beyond 30 days
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‘transient’
‘short term’
‘long term’
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Classification
Degree of Invasiveness
 application to body surface or into body
orifice (as far as pharynx)
 surgically invasive
 implantable
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Classification
Invasive + Duration of Contact
 ‘transient’
 ‘short term’
 ‘long term’
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Class I
Class IIa
Class IIb
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Conformity Assessment Route
Class I (Sterile and Measuring), Class IIa, IIb,
and III require the intervention of a Notified
Body which will be responsible for auditing
the Manufacturer’s quality system
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In-vitro Diagnostic Devices (IVDD)
"any medical device which is a reagent, reagent product,
calibrator, control material, kit, instrument, apparatus,
equipment, or system, whether used alone or in
combination, intended by the manufacturer to be used invitro for the examination of specimens, including blood
and tissue donations, derived from the human body,
solely or principally for the purpose of providing
information:
• concerning a physiological or pathological state, or
• concerning a congenital abnormality, or
• to determine the safety and compatibility with potential
recipients, or
• to monitor therapeutic measures".
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IVDD
Classification
Directive 98/79/EC divides in vitro diagnostic medical
devices into the following four classes:
 All devices except devices for self-testing and devices
in Annex II
 Devices for self-testing which are not included in Annex II
 Devices in Annex II, List A
 Devices in Annex II, List B
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IVDD
Who Ensures that the Requirements Are Fulfilled?
The manufacturers themselves to some extent assume the
responsibility of complying with the requirements.
With respect to general IVDD, except from devices for selftesting and devices in Annex II, it is the manufacturer alone
who carries out the necessary evaluations. In the case of
devices for self-testing and devices in Annex II, the
manufacturer must always have the design and/or the
production of the device approved by an independent third
party, a notified body, before the product may be CE-marked
and marketed.
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Technical File
Technical File contains all the relevant
information that is needed to demonstrate that
the product meets the essential health and
safety requirements of the Directive
...information on e.g. product design, manufacture, testing, risk
analysis and clinical evaluations must be included in the
documentation.
The purpose of the documentation is to enable the manufacturer to
prove that his product complies with the "Essential Requirements"
of the Directive.
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Technical File
Application for the conformity assessment
• Notified Body
• Type of certification (e.g. CE marking...)
• Device classification (product + specified
Directive, Rule used for the devices
classification)
• Conformity assessment route
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Technical File
General description of the product
Intended Use (intended use of MD should be stated)
Principle of the Assay / Test / Function (exact description
of the MD’s function)
Device / Kit Content (description of the content of a pack,
set, etc.)
Shelf-life of the Device (the duration of shelf-life should
be specified, validity testing – references to relevant
standard(s), the place where the expiration date is stated
(label and its location, etc….))
Storage & Stability of the Product / Material / Reagent
(description of conditions in the raw material, semi
finished products and devices finished storerooms:
temperatures and other physical conditions, stability of
material, semi products and devices at defined
conditions..etc.)
Assay / Testing Procedure
Criteria of Acceptability of the Test Results
Calculation & Interpretation of the Results
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Technical File
Regulatory standards applied
• List of the Standards Applied (list of all applied standards /
regulations (usually EN and/or harmonized ones). Add
relevant
standards for sterilization, testing for biological safety, etc –
if
applicable)
• Check List in Respect to the Directive (Essential Safety
Requirements) @
• Correlation among Technical Documents (references, links)
Risk Analysis (Application of the Risk Management to
Medical Devices according with EN ISO 14971)
Clinical Evaluation (copies of completed clinical studies)
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Technical File
List of documents
• Labelling
• Package content
• Instruction for use
• Product technical sheet (product description, manufacturer – name
& address, technical features, in case of set give its content with
description of individual parts, shelf-life, storage and stability,
testing – type of test, results, protocols, standards used)
• Material safety data sheet (identification of raw materials:
physical/chemical properties, supplier, relevant tests – required
quality of materials, hazard identification, health
measures (if applicable during handling with
materials/components), storage - conditions, quality check,
exposure control/ personal protection, stability, toxicological
information, ecological effects, disposal info, transport
information, directives & standards)
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Technical File
Project Description
• History of the product (description of the device manufacture
with respect to its (respective) development (modifications) if
applicable, over the years)
• Customer Complaints (list of professional complaints to the
device according to complaint date, description of
complaint/problem, name of customer, list of investigations to
relevant complaints and solutions)
Detailed list of raw material(s)
• Strategic Raw Material / Reagents (the system of
checking of
raw material and its components (references to
standard, GMP
manual, QS manual should be stated)
• Material of Human Origin (if applicable)
• Information on Substances & Dangerous Materials
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Technical File
Specification of the Product (description of product
characteristics (e.g. by the references to documents given in other
part of the TF)
Compatibility with other MDs (if applicable)
Evaluation Results (if applicable) Electric Safety, EMC, etc.
Data of Stability (references to the relevant tests of device stability
should be stated)
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Technical File
Production
• Method of Manufacture & Procedure Standards
• Validation of the Production/Manufacturing Processes
• List of Equipments (description of purpose of individual
equipment + its location in the manufacture facility)
• Maintenance & Control Program
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Technical File
Quality System Documenation
• Control of Production (reference to GMP(QS) manual
chapter(s),
paragraph(s), etc.)
• Equipments (list of equipments used for QC. References to
standards/directives/technical procedures according to which
is
the control performed)
• Product Maintenance (If applicable. reference(s) to internal
manuals (GMP, QS…) according to which is maintenance
provided)
• Characteristic of the Environment (description of
manufacture
facilities & premises. Description of individual floors/ rooms,
give
dimension, type of activity, equipments installed…etc.)
Declaration of Conformity
Declaration of Agreement with a Notified Body
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Essential Requirements
- General Requirements
- Design & Construction Requirements
- Chemical, Physical and Biological Properties
- Infection and Microbial Contamination
- Construction and Environmental Properties
- Information Supplied by the Manufacturer on
the Label and in the Instructions for Use
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