Medical Device Directive (MDD) 93/42/EEC

as amended by 2007/42/EC

Pavan Kumar Malwade

01 April 2016

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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,

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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Definitions

Medical Device:

Any instrument, apparatus, appliance, software, material or other article, whether used aloneor in combination, including the software intended by its manufacturer to be used specificallyfor diagnostic and/or therapeutic purposes and necessary for its proper application, intendedby 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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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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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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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

demonstrated.

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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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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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MDD 93/42/EEC as amended by 2007/42/EC

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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ARTICLESArticle 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

Article 19 Decision in respect of refusal or restriction

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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

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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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 orificeSurgically invasive Implantable

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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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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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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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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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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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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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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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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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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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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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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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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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Notified Body

• Third party organization appointed by a Member State to undertake

prescribed activities

• Commercial contracts with manufacturers

• Certifications

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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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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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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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Declaration of Conformity

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Thank you

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