1. Medical Devices for the EU
Carl Youngmann, PhD
Regulatory Affairs Certified
Port Townsend, Washington
(360) 379 3660
CYoungmann@gmail.com
9/10/07 1
2. 27 member states of the
European Union
โข Austria โข Germany โข Netherlands
โข Belgium โข Greece โข Poland
โข Bulgaria โข Hungary Portugal
โข Cyprus โข Ireland โข Romania
โข Czech Republic โข Italy โข Slovakia
โข Denmark โข Latvia โข Slovenia
โข Spain
โข Estonia โข Lithuania
โข Sweden
โข Finland โข Luxembourg
โข United
โข France โข Malta Kingdom
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3. The European Free Trade
Association (EFTA)
โข 3 of the 4 states of โข The fourth state,
the EFTA are part of Switzerland, has
the EEA internal bilateral agreements
market: with the EEA.
โ Iceland
โ Norway
โ Liechtenstein
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4. US versus EU Medical Device
Regulation
โข Directives to Member States
โ Implemented by Member State parliaments
in national legislation
โ Overseen by national Competent Authorities
โ Compliance checked by Notified Bodies
โ Enforcement under national jurisdiction
โข Based on compliance not notice or approval
โข No EU centralized authority
โข Different approach to determining standard
of care: national health systems,
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5. The U.S. compared to the E.U.-1
US specific Shared EU specific
Quality System 21 CFR 820 ISO 13485
More definitions Few definitions
Quality Plan Quality System Quality Planning
& Policy
Management
responsibility
Audits
Personnel /
Training
Design Controls
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6. The U.S. compared to the E.U.-2
US specific Shared EU specific
Quality System, Purchasing
continued
Product
Identification
Process Control
Inspection
Measurement &
Test Equipment
Nonconforming
Product
Corrective &
Preventative Action
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7. The U.S. compared to the E.U.-3
US specific Shared EU specific
Quality System, Labeling Packaging Translation
continued Device Master
Record
Device History
Record
Handling,
Storage &
Delivery
Installation
Quality Records
Complaints
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8. The U.S. compared to the E.U.-4
US specific Shared EU specific
Quality System, Servicing
continued
Statistical
Techniques
Risk Management ISO 14971
Product FDA Guidance Biocompatibility MDD Essential
Requirements Requirements
Electrical Safety
Electromagnetic
Compatibility
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9. The U.S. compared to the E.U.-5
US specific Shared EU specific
Product Sterile
Requirements Packaging
continued shelf-life
sterile barrier
shipping
Sterilization
Validation
Post Market MDR Recalls & Post Market
Removals Surveillance
Regulatory 510(K), IDE & Technical File
Compliance PMA CE-Marking
Representation U. S. Agent for Authorized
Devices European
Representative
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10. The U.S. compared to the E.U.-6
US specific Shared EU specific
Clinical IDE ISO 14155-1, -2
Assessments Inspections Audits
biennial GMP initial
pre-PMA continuing
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11. The CE Mark
โข Possibly Communitee
Europรฉen, French for
European Community.
โข Could be Conformitรฉ
Europรฉen.
โข Invented by some
bureaucrat in Brussels.
โข Officially, just a logo
and has no linguistic
meaning.
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12. Medical Device Directives
โข Medical Devices โ Council Directive
93/42/EEC of 14 June 1993 (OJ No L 169/1 of
1993-07-12)
โข Active Implantable Medical Devices โ
Council Directive 90/385/EEC of 20 June
1990 (OJ No L 189/17 of 1990-07-20)
โข In-vitro diagnostic medical devices โ
Directive 98/79/EC of 27 October 1998
(1998-12-07 OJ No L 331/1)
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13. Recent Changes to the MDD
โข Clarification of design documentation and
design review requirements
โข Clarification of the clinical evaluation
requirements
โข Substances of animal origin or containing
human blood
โข Software validation
โข Alignment of the original MDD 93/42/EEC
with other directives
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14. Council Directive 93/42/EEC 14 June
1993 concerning medical devices โ 1
โข 23 Articles โ Classification
โ Definitions, scope โ Conformity assessment
โ Placing on the market and procedures
putting into service โ Registration of persons
โ Essential requirements responsible for placing devices
on the market
โ Free movement, devices
intended for special purposes โ Clinical investigation
โ Reference to standards โ Notified bodies
โ Committee on Standards and โ CE marking and Wrongly
Technical Regulations affixed CE marking
โ Safeguard clause โ Confidentiality
โ Information on incidents โ Implementation, transitional
occurring following placing of provisions
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devices on the market 14
15. Council Directive 93/42/EEC 14 June
1993 concerning medical devices โ 2
โข 12 Annexes
I Essential Requirements
II EC Declaration of Conformity (Full Quality
Assurance โ ISO 13485 + MDD )
III EC Type - Examination
IV EC Verification i.e. batch testing
V EC Declaration of Conformity (Production
Quality Assurance โ ISO 13485 MDD)
VI EC Declaration of Conformity (Product
Quality Assurance โ ISO 13485 + MDD)
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16. Council Directive 93/42/EEC 14 June
1993 concerning medical devices โ 3
โข 12 Annexes
VII EC Declaration of Conformity, self-
certification for Class I products
VIII Statement concerning devices for special
purposes
IX Classification criteria i.e. rules for the
classification of products
X Clinical evaluation
XI Criteria for the designation of Notified
Bodies
XII CE Marking of conformity
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17. CE-Marking Medical Devices
โข Classify the device
โข Assess device conformity
โ Essential Requirements
โ Risk Management
โ Certification Procedures
โข Performance
โข Quality
โ Labeling
โ Technical construction file or design dossier
โข Authorize a European representative
โข CE mark the product
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18. MDD Device Classification
โข Duration of use: transient, short-term
or long-term
โข Invasiveness: non-invasive, body
orifice, surgically invasive, implantable
โข Activity: therapeutical or diagnostic
โข Central circulatory contact
โข Central nervous system contact
MDD Annex IX
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20. 4 ( Really 6 ) Device Classes โ 2
โข Class I (Measuring)
โ scales
โ digital thermometers
โข Class IIa โ medium risk
โ IV catheters
โ tubings for anesthesia / ventilation
โ ultrasound devices
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21. 4 ( Really 6 ) Device Classes โ 3
โข Class IIb โ elevated risk
โ intra-ocular lenses
โ breast implants
โ endoprostheses
โ ventilators
โข Class III โ high risk
โ heart valves
โ reabsorbable implants
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22. Class I Conformity Assessment
โข Manufacturer self-declares conformity
for performance
and
for quality system
โข Aspects of sterile products and measuring
devices relating to sterility and/or metrology
are certified by a Notified Body.
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23. Class IIa Conformity Assessment
โข Manufacturer self-declares conformity
for performance
and
for design control
โข Notified Body must
โ certify full quality assurance system
โ certify production quality assurance system
โ certify final inspection and testing; or
โ exam and test sample products.
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24. Class IIb Conformity Assessment
โข Notified Body will either
certify full quality assurance system
or
test and certify product performance
and
certify production quality assurance system
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25. Class III Conformity Assessment
โข Notified Body will
certify full quality assurance system
and
certify the technical dossier
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26. Technical Construction File (Class I & II)
or Design Dossier (Class III)
โข Essential Requirements Analysis
โ Product design specifications
โ Hazard and risk analysis
โ Verification and validation reports
โข Engineering test reports
โข Laboratory reports
โข Clinical validation
โ Product labeling
โข A combination of elements from the Design
History File and the Device Master Record
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27. Declaration of Conformity
โข Document created by the person placing the
device on the market that clearly identifies:
โ The manufacturer or their AER
โ Manufactureโs or AERโs European Address
โ The device (models, serial numbers, lots,
etc.)
โ The applicable directives
โ The major standards complied with
โ Signed by a responsible authority
โข Included in the device labeling, usually in the
instructions for use and shipping documents
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28. Lumps in the Level Playing Field
โข Each Member State was permitted to
impose requirements particular to their
national cultures, i.e., use of languages
indigenous to their countries
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29. EU National Language Requirements -
1
Austria German
Belgium Dutch + German + French (All three must be used for
patient instructions)
Bulgaria English, Bulgarian for self-test devices only.
Croatia (Pending Croatian
EU state)
Cyprus Non-professional use devices in Greek. Professional
Use devices in Greek or English
Czech Republic Czech
Denmark Danish
Estonia Estonian
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30. EU National Language Requirements - 2
Finland Finnish + Swedish
France French
Germany German
Greece Greek
Hungary Hungarian
Iceland (EFTA) Icelandic
Ireland English
Italy Italian
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31. EU National Language Requirements - 3
Latvia Latvian for professional use; English or German is
accepted
Liechtenstein German
(EFTA)
Lithuania Lithuanian
Luxembourg French
Macedonia
(Pending EU
State)
Malta Maltese or English
Netherlands Dutch
Norway (EFTA) Norwegian
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32. EU National Language Requirements - 4
Poland Polish
Portugal Portuguese
Romania Romanian
Serbia Serbian
Slovakia Slovak
Slovenia Slovenian
Spain Spanish
Sweden Swedish
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33. EU National Language Requirements - 5
Switzerland French, German, Italian
(EFTA)
Turkey (Pending Turkish
EU State)
United Kingdom English
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34. How to label a device for
marketing in Europe - 1
โข Highly simplified instructions
โ Fourth grade vocabulary
โ Simple declarative sentences
โ No or minimal medical terminology
โ Maximum use of graphics
โข Graphics!
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35. How to label a device for
marketing in Europe - 2
โข 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
โ Label only for those markets
โข Sell products F.O.B. in market countries, others in the EU can
purchase across borders
โข Require training for professionals and service personnel where
more complete materials can be provided in English
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36. Post-Market Surveillance
โข Manufacturer must establish systems to
โ Record and analyze customer
responses
โ Process customer complaints
โ Collect, report and analyze any
adverse events
โ Actively monitor use and abuse of the
product
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37. Authorized European Representative
(AER)
โข A point of contact within the EU where the Competent
Authorities can serve notices
โข Generally not a sales office or a business facility
โข Required to be shown on all labeling
โข Only one required for the entire EU
โ Establishes the country of legal jurisdiction for criminal
and civil actions, including insurance
โข Should be knowledgeable in the mechanics of the MDD
โข May be required to respond within 2-3 days with technical
file
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38. Questions?
โข Ask the EU Commission:
ec.europa.eu/enterprise/medical_devic
es/index_en.htm
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