1. Medical Devices for the EU
Carl Youngmann, PhD
Regulatory Affairs Certified
Port Townsend, Washington
(360) 379 3660
CYoungmann@gmail.com
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2. 27 member states of the
European Union
• Austria • Germany • Netherlands
• Belgium • Greece • Poland
• Bulgaria • Hungary Portugal
• Cyprus • Ireland • Romania
• Czech Republic • Italy • Slovakia
• Denmark • Latvia • Slovenia
• Spain
• Estonia • Lithuania
• Sweden
• Finland • Luxembourg
• United
• France • Malta Kingdom
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3. The European Free Trade
Association (EFTA)
• 3 of the 4 states of • The fourth state,
the EFTA are part of Switzerland, has
the EEA internal bilateral agreements
market: with the EEA.
– Iceland
– Norway
– Liechtenstein
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4. 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 not notice or approval
• No EU centralized authority
• 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
• Possibly Communitee
Européen, French for
European Community.
• Could be Conformité
Européen.
• Invented by some
bureaucrat in Brussels.
• Officially, just a logo
and has no linguistic
meaning.
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12. Medical Device Directives
• Medical Devices — Council Directive
93/42/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 June
1990 (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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13. Recent Changes to the MDD
• Clarification of design documentation and
design review requirements
• Clarification of the clinical evaluation
requirements
• Substances of animal origin or containing
human blood
• Software validation
• 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 — 1
• 23 Articles – Classification
– Definitions, scope – Conformity assessment
– Placing on the market and procedures
putting into service – Registration of persons
– Essential requirements responsible for placing devices
on the market
– Free movement, devices
intended for special purposes – Clinical investigation
– Reference to standards – Notified bodies
– Committee on Standards and – CE marking and Wrongly
Technical Regulations affixed CE marking
– Safeguard clause – Confidentiality
– Information on incidents – 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 — 2
• 12 Annexes
I Essential Requirements
II EC Declaration of Conformity (Full Quality
Assurance – ISO 13485 + MDD )
III EC Type - Examination
IV EC Verification i.e. batch testing
V EC Declaration of Conformity (Production
Quality Assurance – ISO 13485 MDD)
VI EC Declaration of Conformity (Product
Quality Assurance – ISO 13485 + MDD)
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16. Council Directive 93/42/EEC 14 June
1993 concerning medical devices — 3
• 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
• 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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18. MDD Device Classification
• Duration of use: transient, short-term
or long-term
• Invasiveness: non-invasive, body
orifice, surgically invasive, implantable
• Activity: therapeutical or diagnostic
• Central circulatory contact
• Central nervous system contact
MDD Annex IX
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19. 4 ( Really 6 ) Device Classes — 1
• Class I – low risk
– non-sterile dressings
– bandages
– hospital gowns
– light sources
• Class I (Sterile)
– disposable surgical instruments
– urine drainage bags
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20. 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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21. 4 ( Really 6 ) Device Classes — 3
• Class IIb – elevated risk
– intra-ocular lenses
– breast implants
– endoprostheses
– ventilators
• Class III – high risk
– heart valves
– reabsorbable implants
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22. Class I Conformity Assessment
• Manufacturer self-declares conformity
for performance
and
for quality system
• 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
• Manufacturer self-declares conformity
for performance
and
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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24. Class IIb Conformity Assessment
• 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
• 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)
• 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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27. Declaration of Conformity
• Document created by the person placing the
device on the market that clearly identifies:
– The manufacturer or their AER
– Manufacture’s or AER’s 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 the
instructions for use and shipping documents
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28. Lumps in the Level Playing Field
• 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
• Highly simplified instructions
– Fourth grade vocabulary
– Simple declarative sentences
– No or minimal medical terminology
– Maximum use of graphics
• Graphics!
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35. 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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36. Post-Market Surveillance
• Manufacturer must establish systems to
– Record and analyze customer
responses
– Process customer complaints
– Collect, report and analyze any
adverse events
– Actively monitor use and abuse of the
product
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37. 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 criminal
and civil actions, including insurance
• Should be knowledgeable in the mechanics of the MDD
• May be required to respond within 2-3 days with technical
file
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38. Questions?
• Ask the EU Commission:
ec.europa.eu/enterprise/medical_devic
es/index_en.htm
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