medical devices for the eu 070910
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Carl Youngmann, PhDRegulatory Affairs Certified
Port Townsend, Washington(360) 379 3660
CYoungmann@gmail.com
Medical Devices for the EU
mailto:CYoungmann@gmail.commailto:CYoungmann@gmail.com -
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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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The U.S. compared to the E.U.-2
Corrective &Preventative Action
NonconformingProduct
Measurement &Test Equipment
Inspection
Process Control
ProductIdentification
PurchasingQuality System,continued
EU specificSharedUS specific
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The U.S. compared to the E.U.-3
Complaints
Quality Records
Installation
Handling,Storage &Delivery
TranslationPackagingLabelingDevice Master
RecordDevice HistoryRecord
Quality System,continued
EU specificSharedUS specific
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The U.S. compared to the E.U.-4
MDD EssentialRequirements
BiocompatibilityFDA GuidanceProductRequirements
Electrical Safety
ElectromagneticCompatibility
ISO 14971Risk Management
StatisticalTechniques
ServicingQuality System,continued
EU specificSharedUS specific
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The U.S. compared to the E.U.-5
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
EU specificSharedUS specific
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The U.S. compared to the E.U.-6
ISO 14155-1, -2IDEClinical
Auditsinitial
continuing
Inspectionsbiennial GMPpre-PMA
Assessments
EU specificSharedUS specific
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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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Council Directive 93/42/EEC 14 June
1993 concerning medical devices 2
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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Council Directive 93/42/EEC 14 June
1993 concerning medical devices 3
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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4 ( Really 6 ) Device Classes 2
Class I (Measuring)
scales
digital thermometers Class IIa medium risk
IV catheters
tubings for anesthesia / ventilation
ultrasound devices
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4 ( Really 6 ) Device Classes 3
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
certify full quality assurance system
or
test and certify product performanceandcertify production quality assurance system
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Class III Conformity Assessment Notified Body will
certify full quality assurance system
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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EU National Language Requirements - 3
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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EU National Language Requirements - 4
SwedishSweden
SpanishSpain
SlovenianSlovenia
SlovakSlovakia
SerbianSerbia
RomanianRomania
PortuguesePortugal
PolishPoland
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EU National Language Requirements - 5
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
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