Medical Device Directive

1. Medical Device Directive (MDD)
93/42/EEC
as amended by 2007/42/EC
Pavan Kumar Malwade
01 April 2016
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2. European Union
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The EU is a unique economic and political partnership
between 28 European countries that together cover much of the
continent.
The EU was created in the aftermath of the Second World War.
• to foster economic cooperation
• economically interdependent and
• avoid conflict.
The result was the European Economic Community (EEC), created in 1958,

3. Device Directives (CE Marking)
 Medical Devices (MDD) – 93/42/EEC
 Active Implantable (AIMDD) - 90/385/EEC
 In-Vitro Diagnostics (IVDD) – 98/79/EC
Council Directive 2001/83/EC - Device is assembled by device is placed on
the market in such a way that the device and the medicinal product form a
single integral product which is intended exclusively for use in the given
combination and which is not reusable
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4. Definitions
Medical Device:
Any instrument, apparatus, appliance, software, material or other article, whether used alone
or in combination, including the software intended by its manufacturer to be used specifically
for diagnostic and/or therapeutic purposes and necessary for its proper application, intended
by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means;
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5. Definitions
Custom-made device
any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives,
under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.
Device intended for clinical investigation
any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in
Section 2.1 of Annex X in an adequate human clinical environment.
Manufacturer
The natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it
is placed on the market under his own name, regardless of whether these operations are carried out by that person
himself or on his behalf by a third party.
Notified Body
An entity that has been accredited by a Member State to assess whether a product to be placed on the EU market
meets certain preordained standards.
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6. Definitions
Intended purpose
The use for which the device is intended according to the data supplied by the manufacturer on the
labelling, in the instructions and/or in promotional materials.
Placing on the market
The first making available in return for payment or free of charge of a device other than a device intended
for clinical investigation, with a view to distribution and/or use on the Community market, regardless of
whether it is new or fully refurbished.
Putting into service
The stage at which a device has been made available to the final user as being ready for use on the
Community market for the first time for its intended purpose.
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7. Definitions
Authorised representative
Any natural or legal person established in the Community who, explicitly designated by the
manufacturer, acts and may be addressed by authorities and bodies in the Community
instead of the manufacturer with regard to the latter's obligations under this Directive.
Clinical data
The safety and/or performance information that is generated from the use of a device.
Clinical data are sourced from:
— clinical investigation(s) of the device concerned; or
— clinical investigation(s) or other studies reported in the scientific literature, of a similar
device for which equivalence to the device in question can be demonstrated; or
— published and/or unpublished reports on other clinical experience of either the device in
question or a similar device for which equivalence to the device in question can be 7

8. Definitions
Device subcategory
A set of devices having common areas of intended use or common technology.
Generic device group
A set of devices having the same or similar intended uses or commonality of technology
allowing them to be classified in a generic manner not reflecting specific characteristics.
Single use device
A device intended to be used once only for a single patient.
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9. MDD 93/42/EEC - Compliance
• Scope of the Directive 93/42/EEC
• Classification
• Conformity Assessment Route
• Compliance to the Essential Requirements
• Harmonized standards
• Technical File
• Risk assessment
• Notified Body
• Authorized Representative and Competent Authority registration
• Vigilance system
• CE Marking
• Declaration of Conformity
• Adherence to the MDD requirements for conducting self inspection
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10. 10
MDD 93/42/EEC as amended by 2007/42/EC

11. MDD 93/42/EEC shall NOT apply to
• invitro diagnostic devices;
• active implantable devices covered by Directive 90/385/EEC;
• medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that
Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
• cosmetic products covered by Directive 76/768/EEC (2);
• human blood, blood products, plasma or blood cells of human origin or to devices which
incorporate at the time of placing on the market such blood products, plasma or cells, with the exception
of devices referred to in paragraph 4a;
• transplants or tissues or cells of human origin nor to products incorporating or derived from tissues
or cells of human origin, with the exception of devices referred to in paragraph 4a;
• transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal
tissue which is rendered non-viable or non-viable products derived from animal tissue.
• n
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12. ARTICLES
Article 1 Definitions, scope
Article 2 Placing on the market and putting into service
Article 3 Essential requirements
Article 4 Free movement, devices intended for special purposes
Article 5 Reference to standards
Article 6 & Article 7 Committee on Standards and Technical Regulations
Article 8 Safeguard clause
Article 9 Classification
Article 10 Information on incidents occuring following placing of devices on the market
Article 11 Conformity assessment procedures
Article 12 Particular procedure for systems and procedure packs and procedure for sterilisation
Article 12a Reprocessing of medical devices
Article 13 Decisions with regard to classification and derogation clause
Article 14 Registration of persons responsible for placing devices on the market
Article 14a European databank
Article 14b Particular health monitoring measures
Article 15 Clinical investigation
Article 16 Notified bodies
Article 17 CE marking
Article 18 Wrongly affixed CE marking 12

13. ANNEX
Annex I: Essential requirements
a) General requirements
b) Requirements regarding design and construction.
Annex II: EC Declaration of conformity
Annex III: EC type examination
Annex IV:EC verification
Annex V,VI,VII: EC Declaration of conformity
Annex VIII: Statement concerning devices for special purposes
Annex IX: Classification criteria
a) Definition for the classification rules
b) Implementing rules
c) Classification
Annex X: Clinical evaluation
a) General provisions
b) Clinical investigation
Annex XI: Criteria to be met for the designation of notified bodies
Annex XII: CE marking of conformity 13

14. Guidance Documents
• EU Commission
INTERPRETATION OF THE MEDICAL DEVICE DIRECTIVES IN RELATION
TO MEDICAL DEVICE OWN BRAND LABELLERS
• MEDDEV (Medical Devices Info)
• Manuals (Borderline and Classification Expert Group)
• NB-MED
• GMDVS (EU Commission MEDDEV document regarding
• "Guidelines for Medical Device Vigilance System“)
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15. How device Classification is Determined
Duration of contact:
< 60 minutes Transient
< 30 days Short term
> 30 days Long term
Degree of invasiveness:
 Application to body surface or into body orifice
 Surgically invasive
 Implantable
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16. How Classification is Determined
Degree of invasiveness
Duration of contact
 Transient Class I Low risk Thermometers
 Short term Class IIa Medium risk Needles
 Long term Class IIb Medium risk Insulin pens
 Long term Class III High risk Implants
Class I non sterile and non measuring
Class I sterile and measuring
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17. Conformity Assessment Routes
• Class I – Non-Sterile, Non-Measuring - Annex VII
• Class I - Sterile or Measuring - Annex VII and Annex IV, V or VI.
• Class IIa - Annex II (except Section 4, Design Dossier), or Annex VII plus IV, V or VI.
• Class IIb - Annex II (except Section 4, Design Dossier), or Annex III plus IV, V or VI.
• Class III - Annex II (plus Section 4, Design Dossier), or Annex III plus IV or V.
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18. Conformity Assessment Routes
Annex II – EC Declaration of Conformity
(Full Quality Assurance System)
• Most comprehensive conformity assessment procedure
• Full quality system including the design phase for new devices or changes of
existing devices;
• EN ISO 13485 or use an equivalent quality system suitable
Class I (Sterile and Measuring), IIa, IIb and III manufacturers can choose to follow Annex
II and implement a full quality system that covers all classes of products.
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19. Conformity Assessment Routes
Annex III - EC Type Examination
• Procedure for the product design which involves examination
• Third party testing of representative samples of the device and certification that the device meets the
applicable essential requirements of the MDD;
• EC Type Examination is applicable only to class IIb and III devices
Class IIb and III manufacturers can elect to have a Notified Body do an audit using a representative sample of
the company’s production to ascertain compliance with the directive. Used when Annex II is not the preferred
route to compliance. Annex IV, V or VI must be used in conjunction with Annex III.
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20. Conformity Assessment Routes
Annex IV – EC Verification
• Comply applicable requirements as per MDD
• EN ISO 13485
• Other Technical Specifications
The Notified Body can sample up to 100% of the products, or may do statistical batch
testing. If batch testing is done and accepted by the Notified Body, all products in the
batch can bear the CE Marking.
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21. Conformity Assessment Routes
Annex V - EC Declaration of Conformity
(Production Quality Assurance)
• Excluding the design phase of new devices but including all other aspects of
conformity with the MDD
• Most suitable procedure for sterile class IIa devices
• EN ISO 13485.
This is much the same as Annex II but without design inspection. Often used by
companies that manufacturer Class I sterile/measuring and Class IIa, and those that do
not design their own products.
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22. Conformity Assessment Routes
Annex VI - EC Declaration of Conformity
(Product Quality Assurance)
• Devices whose relevant properties can be assessed in final inspection
• EN ISO 13485
• Not suitable for devices involving special manufacturing processes requiring validation,
like sterilization
• May not be used for the assessment of class III products.
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23. Conformity Assessment Routes
Annex VII - EC Declaration of Conformity
• Manufacturer himself declares the compliance of his devices with the MDD;
• Suitable for class I devices, and required for class IIa devices in combination
with one of the Annexes IV, V, or VI.
• Requires the manufacturer to compile a Technical File and conduct a risk
assessment.
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24. Harmonized Standards
• Harmonized European Standards
• “Voluntary” application of Standards
• Presumption of Conformity (Article 5, MDD and
IVDD)
• Conformity to Standard
• Conformity to Essential Requirements
• Hierarchy of Standards:
 Harmonized – published in the Official Journal
 EN
 ISO
 National (BS, DS, DIN, ASTM)
 Industry-specific
 Local, company-specific
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25. Technical File & Design Dossier
• Contains all the relevant information to
demonstrate that the product meets the
Essential Requirements of the Directive
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26. 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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27. Risk Management
EN ISO 14971:2012 is used to:
 Identify the product and describe the intended use
 Characteristics which could affect safety
 Identify possible hazards
 Estimate the risk, and…
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28. Notified Body
• Third party organization appointed by a Member State to undertake
prescribed activities
• Commercial contracts with manufacturers
• Certifications
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29. Authorized Representation
 Authorized Representative for Europe in the event the manufacturer is
not established within the EEA
 Listed on the label and/or packaging
 Name of the manufacturer and the device must be notified to the Competent
Authority
 Keeps the Technical File available for review by Competent Authorities
 Plays an essential role in vigilance procedures and Post-market Surveillance
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30. Post Marketing Surveillance
• Required for all devices
• Review of market, field data, complaints, investigation,
corrective actions
• Systematic records kept
• Vigilance, MEDDEV 2.12.1, Rev. 5
• The manufacturer must:
• Institute and keep up to date a systematic procedure
to review experience gained from devices in the post-
production phase and;
• Implement appropriate means to apply any necessary
corrective actions
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31. CE Marking
• Implies conformance with all European Directives
• Inspection Authorities
• Preempts all other marks for same requirements
• Not a quality mark!
• Measurement
• Affixing
• Labeling
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32. Declaration of Conformity
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33. Thank you
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