Medical Devices for the EU

Carl Youngmann, PhD

Regulatory Affairs Certified

Port Townsend, Washington (360) 379 3660 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 United Kingdom
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The European Free Trade Association (EFTA)

3 of the 4 states of the EFTA are part of the EEA internal market:
Iceland Norway Liechtenstein

The fourth state, Switzerland, has bilateral agreements with 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 not notice or approval No EU centralized authority Different approach to determining standard of care: national health systems,
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The U.S. compared to the E.U.-1

US specific
Quality System 21 CFR 820 More definitions Quality Plan Quality System & Policy Management responsibility Audits Personnel / Training Design Controls
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Shared

EU specific
ISO 13485 Few definitions Quality Planning

The U.S. compared to the E.U.-2

US specific
Quality System, continued

Shared
Purchasing Product Identification Process Control Inspection Measurement & Test Equipment Nonconforming Product Corrective & Preventative Action

EU specific

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The U.S. compared to the E.U.-3

US specific
Quality System, continued Labeling Device Master Record Device History Record

Shared
Packaging

EU specific
Translation

Handling, Storage & Delivery Installation Quality Records Complaints

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The U.S. compared to the E.U.-4

US specific
Quality System, continued

Shared
Servicing Statistical Techniques

EU specific

Risk Management Product Requirements FDA Guidance

ISO 14971 Biocompatibility Electrical Safety Electromagnetic Compatibility MDD Essential Requirements

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The U.S. compared to the E.U.-5

US specific
Product Requirements continued

Shared
Sterile Packaging shelf-life sterile barrier shipping Sterilization Validation

EU specific

Post Market Regulatory Compliance Representation

MDR 510(K), IDE & PMA U. S. Agent for Devices

Recalls & Removals

Post Market Surveillance Technical File CE-Marking Authorized European Representative

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The U.S. compared to the E.U.-6

US specific
Clinical Assessments IDE Inspections biennial GMP pre-PMA

Shared

EU specific
ISO 14155-1, -2 Audits initial continuing

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The CE Mark
Possibly Communitee Europen, French for European Community. Could be Conformit Europen. Invented by some bureaucrat in Brussels. Officially, just a logo and has no linguistic meaning.
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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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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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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, devices intended for special purposes Reference to standards Committee on Standards and Technical Regulations Safeguard clause Information on incidents occurring following placing of devices on the market 9/10/07 Classification Conformity assessment procedures Registration of persons responsible for placing devices on the market Clinical investigation Notified bodies CE marking and Wrongly affixed CE marking Confidentiality Implementation, transitional provisions
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Council Directive 93/42/EEC 14 June 1993 concerning medical devices 2 12 Annexes

Essential Requirements 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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I II

Council Directive 93/42/EEC 14 June 1993 concerning medical devices 3 12 Annexes

VII EC Declaration of Conformity, selfcertification 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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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-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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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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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 implants endoprostheses ventilators

Class III high risk

heart 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 measuring devices relating to sterility and/or metrology are certified by a Notified Body.
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Class IIa Conformity Assessment

Manufacturer self-declares conformity for performance and for design control Notified Body must

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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 performance and certify 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) 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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Declaration of Conformity
Document created by the person placing the device 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 the instructions for use and shipping documents
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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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EU National Language Requirements 1

Austria Belgium Bulgaria Croatia (Pending EU state) Cyprus Czech Republic Denmark Estonia
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German Dutch + German + French (All three must be used for patient instructions) English, Bulgarian for self-test devices only. Croatian Non-professional use devices in Greek. Professional Use devices in Greek or English Czech Danish Estonian
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EU National Language Requirements - 2

Finland France Germany Greece Hungary Iceland (EFTA) Ireland Italy Finnish + Swedish French German Greek Hungarian Icelandic English Italian

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EU National Language Requirements - 3

Latvia Liechtenstein (EFTA) Lithuania Luxembourg Macedonia (Pending EU State) Malta Netherlands Norway (EFTA)
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Latvian for professional use; English or German is accepted German Lithuanian French

Maltese or English Dutch Norwegian

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EU National Language Requirements - 4

Poland Portugal Romania Serbia Slovakia Slovenia Spain Sweden Polish Portuguese Romanian Serbian Slovak Slovenian Spanish Swedish

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EU National Language Requirements - 5

Switzerland (EFTA) Turkey (Pending EU State) United Kingdom French, German, Italian Turkish English

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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 any adverse events Actively monitor use and abuse of the product
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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 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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Questions?
Ask the EU Commission: ec.europa.eu/enterprise/medical_devic es/index_en.htm

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