medical devices for the eu 070910

8/6/2019 Medical Devices for the EU 070910

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Carl Youngmann, PhDRegulatory Affairs Certified

Port Townsend, Washington(360) 379 3660

[email protected]

Medical Devices for the EU
mailto:[email protected]:[email protected]


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27 member states of the

European Union

Austria

Belgium

Bulgaria Cyprus

Czech Republic

Denmark

Estonia Finland

France

Germany

Greece

Hungary Ireland

Italy

Latvia

Lithuania Luxembourg

Malta

Netherlands

Poland

Portugal Romania

Slovakia

Slovenia

Spain Sweden

UnitedKingdom


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The European Free Trade

Association (EFTA)

3 of the 4 states ofthe EFTA are part of

the EEA internalmarket: Iceland

Norway

Liechtenstein

The fourth state,Switzerland, has

bilateral agreementswith the EEA.


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US versus EU Medical Device

Regulation

Directives to Member States Implemented by Member State parliaments

in national legislation Overseen by national Competent Authorities

Compliance checked by Notified Bodies

Enforcement under national jurisdiction

Based on compliance notnotice or approval

No EU centralized authority

Different approach to determining standardof care: national health systems,


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The U.S. compared to the E.U.-1

Design Controls

Personnel /Training

Audits

Managementresponsibility

Quality PlanningQuality System& Policy

Quality Plan

Few definitionsMore definitions

ISO 1348521 CFR 820Quality System

EU specificSharedUS specific


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Corrective &Preventative Action

NonconformingProduct

Measurement &Test Equipment

Inspection

Process Control

ProductIdentification

PurchasingQuality System,continued



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Complaints

Quality Records

Installation

Handling,Storage &Delivery

TranslationPackagingLabelingDevice Master

RecordDevice HistoryRecord

Quality System,continued



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MDD EssentialRequirements

BiocompatibilityFDA GuidanceProductRequirements

Electrical Safety

ElectromagneticCompatibility

ISO 14971Risk Management

StatisticalTechniques

ServicingQuality System,continued



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SterilizationValidation

Post MarketSurveillance

Recalls &Removals

MDRPost Market

Technical FileCE-Marking

510(K), IDE &

PMA

RegulatoryCompliance

AuthorizedEuropeanRepresentative

U. S. Agent forDevices

Representation

SterilePackaging

shelf-life

sterile barriershipping

ProductRequirements

continued



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ISO 14155-1, -2IDEClinical

Auditsinitial

continuing

Inspectionsbiennial GMPpre-PMA

Assessments



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The CE Mark

PossiblyCommuniteeEuropen, French for

European Community. Could be ConformitEuropen.

Invented by somebureaucrat in Brussels.

Officially, just a logoand has no linguisticmeaning.


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Medical Device Directives

Medical Devices Council Directive93/42/EEC of 14 June 1993 (OJ No L 169/1 of

1993-07-12) Active Implantable Medical Devices

Council Directive 90/385/EEC of 20 June1990 (OJ No L 189/17 of 1990-07-20)

In-vitro diagnostic medical devices Directive 98/79/EC of 27 October 1998(1998-12-07 OJ No L 331/1)


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Recent Changes to the MDD

Clarification of design documentation anddesign review requirements

Clarification of the clinical evaluationrequirements

Substances of animal origin or containinghuman blood

Software validation Alignment of the original MDD 93/42/EEC

with other directives


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Council Directive 93/42/EEC 14 June

1993 concerning medical devices 1

23 Articles Definitions, scope

Placing on the market and

putting into service

Essential requirements

Free movement, devicesintended for special purposes

Reference to standards

Committee on Standards andTechnical Regulations

Safeguard clause

Information on incidentsoccurring following placing ofdevices on the market

Classification

Conformity assessmentprocedures

Registration of personsresponsible for placing deviceson the market

Clinical investigation

Notified bodies

CE marking and Wronglyaffixed CE marking

Confidentiality

Implementation, transitionalprovisions


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12 AnnexesI Essential Requirements

II EC Declaration of Conformity (Full QualityAssurance ISO 13485 + MDD )

III EC Type - Examination

IV EC Verification i.e. batch testing

V EC Declaration of Conformity (Production

Quality Assurance ISO 13485MDD)VI EC Declaration of Conformity (Product

Quality Assurance ISO 13485+ MDD)


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12 AnnexesVII EC Declaration of Conformity, self-

certification for Class I productsVIII Statement concerning devices for special

purposes

IX Classification criteria i.e. rules for theclassification of products

X Clinical evaluationXI Criteria for the designation of Notified

Bodies

XII CE Marking of conformity


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CE-Marking Medical Devices

Classify the device

Assess device conformity Essential Requirements

Risk Management Certification Procedures

Performance

Quality

Labeling

Technical construction file or design dossier

Authorize a European representative

CE mark the product


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MDD Device Classification

Duration of use: transient, short-termor long-term

Invasiveness: non-invasive, bodyorifice, surgically invasive, implantable

Activity: therapeutical or diagnostic

Central circulatory contact

Central nervous system contact

MDD Annex IX


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4 ( Really 6 ) Device Classes 1

Class I low risk

non-sterile dressings

bandageshospital gowns

light sources

Class I (Sterile)

disposable surgical instruments

urine drainage bags


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Class I (Measuring)

scales

digital thermometers Class IIa medium risk

IV catheters

tubings for anesthesia / ventilation

ultrasound devices


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Class IIb elevated risk

intra-ocular lenses

breast implantsendoprostheses

ventilators

Class III high riskheart valves

reabsorbable implants


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Class I Conformity Assessment

Manufacturer self-declares conformity

for performance

and

for quality system

Aspects of sterile products and measuringdevices relating to sterility and/or metrologyare certified by a Notified Body.


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Class IIa Conformity Assessment

Manufacturer self-declares conformityfor performanceand

for design control

Notified Body must

certify full quality assurance system

certify production quality assurance system

certify final inspection and testing; or

exam and test sample products.


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Class IIb Conformity Assessment

Notified Body will either


or

test and certify product performanceandcertify production quality assurance system


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Class III Conformity Assessment Notified Body will


and

certify the technical dossier


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Technical Construction File (Class I & II)

orDesign Dossier (Class III)

Essential Requirements Analysis Product design specifications

Hazard and risk analysis Verification and validation reports

Engineering test reports

Laboratory reports

Clinical validation

Product labeling A combination of elements from the Design

History File and the Device Master Record


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Declaration of Conformity

Document created by the person placing thedevice on the market that clearly identifies: The manufacturer or their AER

Manufactures or AERs European Address The device (models, serial numbers, lots,

etc.)

The applicable directives

The major standards complied with

Signed by a responsible authority

Included in the device labeling, usually in theinstructions for use and shipping documents


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Lumps in the Level Playing Field

Each Member State was permitted toimpose requirements particular to their

national cultures, i.e., use of languagesindigenous to their countries


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EU National Language Requirements -

1

EstonianEstonia

DanishDenmark

CzechCzech Republic

Non-professional use devices in Greek. ProfessionalUse devices in Greek or English

Cyprus

CroatianCroatia (PendingEU state)

English, Bulgarian for self-test devices only.Bulgaria

Dutch + German + French (All three must be used forpatient instructions)

Belgium

GermanAustria


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EU National Language Requirements - 2

ItalianItaly

EnglishIreland

IcelandicIceland (EFTA)

HungarianHungary

GreekGreece

GermanGermany

FrenchFrance

Finnish + SwedishFinland


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NorwegianNorway (EFTA)

DutchNetherlands

Maltese or EnglishMalta

Macedonia(Pending EUState)

FrenchLuxembourg

LithuanianLithuania

GermanLiechtenstein(EFTA)

Latvian for professional use; English or German isaccepted

Latvia


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SwedishSweden

SpanishSpain

SlovenianSlovenia

SlovakSlovakia

SerbianSerbia

RomanianRomania

PortuguesePortugal

PolishPoland


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EnglishUnited Kingdom

TurkishTurkey (PendingEU State)

French, German, ItalianSwitzerland(EFTA)


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How to label a device for

marketing in Europe - 1

Highly simplified instructions

Fourth grade vocabulary

Simple declarative sentences No or minimal medical terminology

Maximum use of graphics

Graphics!


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How to label a device for

marketing in Europe - 2

Limit marketing to a few of the largest countries, e.g., UK (61M),

France (64M), Germany (84M), Italy (54M) & Spain (45M) to

reach 62% of the 494M EU residents

Label only for those markets

Sell products F.O.B. in market countries, others in the EU can

purchase across borders

Require training for professionals and service personnel where

more complete materials can be provided in English


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Post-Market Surveillance

Manufacturer must establish systems to

Record and analyze customer

responses

Process customer complaints

Collect, report and analyze anyadverse events

Actively monitor use and abuse of theproduct


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Authorized European Representative

(AER) A point of contact within the EU where the Competent

Authorities can serve notices

Generally not a sales office or a business facility

Required to be shown on all labeling Only one required for the entire EU

Establishes the country of legal jurisdiction for criminaland civil actions, including insurance

Should be knowledgeable in the mechanics of the MDD

May be required to respond within 2-3 days with technicalfile


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Questions?

Ask the EU Commission:ec.europa.eu/enterprise/medical_devic

es/index_en.htm

medical devices for the eu 070910

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