財團法人工業技術研究院量測技術發展中心 1999/5/141...

1999/5/14 1

財團法人工業技術研究院量測技術發展中心

歐盟對醫療器材之管理

張明正工程師

工研院量測中心 / 醫療器材驗證室

1999/5/14 2


European Council Regulations

• Brief in European Council Directive

• CE Marking Conformity Assessment

• EC Medical Devices Classification

• Medical Device Standards

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European Council Directives

• 90/385/EEC: – Active implantable medical devices directive.

• 93/42/EEC:– Medical devices directive.

• 98/79/EC:– In vitro medical devices directive.

• 93/86/EEC:– CE marking Directive.

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AIMD 90/385/EEC

• Cover all powered implants or partial implants that are left in the human body.

• Adopted by the European Council in June 1990.

• Came into effect on 1st January 1993.

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AIMD 90/385/EEC

• Article 1 ~17

– Definitions and Clarification

– Member States’ Responsibility

– Free Marketing Policy

– Custom-Made and Clinical Investigation Devices

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MD Directive 93/42/EEC

• Cover most other products.

• Took effect on 1st January 1995.

• A transitional period in force until 13th Jane 1998.

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• Does not apply to:

– In vitro diagnostic devices;

– Active implantable devices;

– Medical products covered by directive 65/65/EEC;

– Cosmetic products covered by 76/786/EEC.

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IVD Directive 98/79/EC

• Cover in vitro diagnostic medical devices.

• Took effect on 7th December 1998.

• A transitional period in force until December 2003.

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• In vitro diagnostic medical devices should provide patients, users, and third parties with a high level of health protection and attain the performance levels by the manufacturer.

• Maintenance of improvement of the level of health protection attained in the Member States is one of the main objectives of it.

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• Council directive 90/385 EEC and 93/42/EEC concerning medical devices with the exclusion of in vitro diagnostic medical devices.

• Seeks to extend the harmonization to in vitro medical devices

• Based largely on the provision of 90/385 & 93/42 EEC.

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CE Marking Directive 93/86/EEC

• Came into force on the 1st January 1995.

– Will be compulsory for all medical devices as the directives relating to them come into force.

– The only exceptions are custom-made and clinical investigation devices.

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AIMD 90/385/EEC

• ANNEX 1~6 (CE marking Procedures)

– Essential Requirements

– EC Declaration of Conformity

– EC Type-Examination

– EC Verification

– EC Declaration of Conformity to Type

– Device Intended for Special Purpose

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EC Declaration of Conformity( 90/385/EEC Annex 2)

• Complete quality assurance (EN 46001)

– from design to final control

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EC Type-Examination(90/385/EEC Annex 3)

• Notified bodied certification.

• The application shall be made by the manufacturer or by his authorized representative in the community.

• The application must make it possible to understand the design, the manufacture and the performances of the product.

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EC Verification(90/385/EEC Annex 4)

• The act by which a notified body verifies and certifies that products conform to the type describe in the EC type-examination certificate and satisfy the relevant requirements.

• The manufacturer shall undertake to institute and keep up-dated a post-marketing surveillance system.

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Declaration of Conformity to Type ( 90/385/EEC Annex 5)

• Assurance of production quality (EN 46002)

– from manufacture to final inspection.

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Conformity Assessment (90/385/EEC )

• The manufacturer must, in order to affix the CE mark, at his own choice:

– Annex 2 ; or

– Annex 3, coupled with:Annex 4 ( EC verification)

Annex 5 (Declaration of Conformity to type)

– Annex 6, for Custom-made devices

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Custom-made Devices (Declaration of Conformity 90/385 EEC)

• Data allowing the device in question to be identified.

• A statement affirming that the device is intended for exclusion use by a particular patient, together use his/her name.

• The name of doctor who drew up the prescription and, if applicable, the name of the clinic concerned,

• The particular features of the device as described by the medical prescription concerned,

• A statement affirming the device complies with essential requirements and, where applicable, indicating which have not been wholly met, together with the ground.

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Custom-made Devices(90/385/EEC )

• Documentation enabling the design, Manufacture and performances of the product, including the expected performances,

• Manufacturer shall take all necessary measure to see the manufacturing process ensures the products conform to the documentation referred to in the above paragraph.

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• Devices for clinical investigations:

– At least 60 days before the commencement of the investigations, submit the statement referred to in Annex 6 to the competent authorities of the Member State.

– The Member States shall, if necessary, take the appropriate steps to ensure public health and order.

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Devices Intended for Clinical Investigations (90/385/EEC)

• Data allowing the device in question to be identified,

• An investigation plan giving in particular the purpose, scope and number of the devices concerned,

• The name of doctor and of the institution responsible for the investigation,

• The place, date of commencement and duration scheduled for the investigation,

• A statement affirming the device complies with essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.

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Clinical Evaluation(Annex 7)

• General provision

– As referred to Annex 2, sec. 4.2 and Annex 3, sec. 3

• Clinical investigation

– Purpose

– Ethical consideration

– Methods

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• Article 1 ~ 23.

• Annex 1~7 (CE marking procedures):– Essential Requirements– Full Quality Assurance System– EC Type-Examination– EC Verification– Production Quality Assurance– Product Quality Assurance– Annex 7, Declaration of Conformity

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EC Declaration of Conformity( 93/42/EEC Annex 2)

• Full quality assurance (EN 46001)

– from design to final inspection.

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EC Type-Examination(93/42/EEC Annex 3)

• Notified bodied certification.

• The application shall be made by the manufacturer or by his authorized representative in the community.

• The application must make it possible to understand the design, the manufacture and the performances of the product.

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EC Verification(93/42/EEC Annex 4)

• The act by which a notified body verifies and certifies that products conform to the type describe in the EC type-examination certificate and satisfy the relevant requirements.

• The manufacturer shall undertake to institute and keep up-dated a post-marketing surveillance system.

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Declaration of Conformity( 93/42/EEC Annex 5)

• Assurance of production quality (EN 46002)

– from manufacture to final inspection.

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• Product quality assurance

– Final inspection and testing of the product.

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• Technical documents, and including the declaration of conformity statement,

• The technical documents must allow assessment of the conformity of the product with the requirements of the directive.

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Technical Documents

• A general description of the product,

• Design drawings. Methods of manufacture envisaged and diagrams of components, sub-assemblies, circuit, etc.,

• Risk analysis activities,

• Sterilization methods,

• Test report and clinical data( if any)

• Labeling

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• Class III devices:

– Annex 2 ; or

– Annex 3, coupled with:Annex 4 ( EC verification);

Annex 5 (Production quality assurance).

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• Class IIa devices:

– Annex 7 coupled with either:

Annex 4 (EC verification);

Annex 5 (Production quality assurance) ;

Annex 6 (Product quality assurance).

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• Class IIb devices:

– Annex 2 ( sec.4 is not applicable);

– Annex 3, coupled with:

Annex 4 (EC verification)

Annex 5 (Production quality assurance)

Annex 6 (Product quality assurance)

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• Class I devices:

– CE marking procedure referred to Annex 7.

– Draw up the EC declaration of conformity required before placing the device on the market.

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• Custom-made and devices for clinical investigation :

– CE marking procedure follows Annex 8.

– Draw up the EC declaration of conformity required before placing the device on the market

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Registration (93/42/EEC)

• To whom places devices on the market referred to in Article 11(5) and (6), and;

• Any other natural or legal person engaged in the activities referred to in Article 12 .

– Manufacturer, or

– Persons responsible for marketing.

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Notified Bodies (93/42/EEC)

• Carry out the tasks pertaining to the procedures referred to in Article 11 and other specific tasks.

• The commission shall assign identification numbers to these bodies, hereinafter referred to as ‘notified bodies’.

• Member States shall apply the criteria set out in Annex 11 for the designation of bodies.

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• Annex 1~8 (CE marking procedures)– Essential Requirements– Devices Referred to in Article 9(2) & (3)– EC Declaration of Conformity– Full Quality Assurance System– EC Type-Examination– EC Verification– Production Quality Assurance– Product Quality Assurance

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EC Declaration of Conformity (98/79/EC Annex 3)

• Manufacturer must prepare the technical documentation and ensure the manufacturing process follows the principles of quality assurance.

• Devices for self-testing, the manufacturer shall lodge an application for examination of the design with a notified body.

• Notified body shall examine the application.

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Conformity Assessment(1) (98/79/EC )

• All devices except for listed in Annex 2 and devices for performance evaluation:

– Annex 3, and declaration for conformity.

• Devices for self-testing other than in Annex2 and devices for performance evaluation:

– Annex 3, point 6, or

– Annex 2, or referred to (2) or (3)

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Conformity Assessment (2)(98/79/EC )

• Annex 2, list A devices:

– Annex 4 ( full quality assurance), or

– EC Type-Examination, coupled with:

Annex 7 (production quality assurance)

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Conformity Assessment (3)(98/79/EC )

• Annex 2, list B devices:

– Annex 4 ( full quality assurance), or

– EC Type-Examination, coupled with:

Annex 6 (EC verification), or

Annex 7 (production quality assurance)

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Performance Evaluation 98/79/EC(Annex 8)

• Data allowing identification of the device in question,

• An evaluation plan stating in the purpose, scientific, technical or medical ground, scope, and number of devices concerned.

• List of labs or institute taking part in,

• Starting date and scheduled duration,

• A statement of conformity to the Directive.

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Notified Bodies (98/79/EC)

• Carry out the tasks pertaining to the procedures referred to in Article 9 and other specific tasks.

• Member States shall apply the criteria set out in Annex 11 for the designation of bodies and apply continual surveillance.

• Notified Bodies shall, on request, supply all relevant information and documents, including budgetary documents.

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Criteria to Be Met for Notified Bodies

• Sound vocational training covering all the assessment and verification operations,

• Satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspection,

• The ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out

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Purpose of the EC Directives

• Not to create trade barriers against the free marketing of any CE-marked product within the EU;

• To indicate the product should complies with its relevant directive, and to be applied to any product imported from outside the EU.

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EC MD Classification

• For feasible economically and justifiable in practice.

• A graduated system of control is more appropriate.

• To channel medical devices into the proper conformity assessment route.

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• Active Implantable Device

• Medical Devices

– Class I (Low risk)

– Class IIa and IIb (Medium risk)

– Class III (High risk)

• In Vitro Diagnostic Devices

Four Class Classification vs. AIMD & IVD

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Philosophy of EC Medical Device Classification

• Technical features and potential hazard.

• Duration of contact with the body.

• Degree of invasiveness and local vs. system effect.

• The human body is a relatively unchanging element of the equation.

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Medical Devices Standards

• EN 46001/2:1996 ( application standard )

• BS EN 724: 1995 ( guidance standard )

– Non-active medical devices.


– In vitro diagnostics.


– Active medical devices.

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BS EN 50103: 1996

• Provides active medical device examples of how to meet the requirements, recognizing that other methods which achieve the same ends are equally acceptable;

• Gives general advice on how to meet the requirement;

• Draws attention to the aspects of requirements that may not be readily apparent to those unfamiliar with quality systems for the active medical device industry.

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BS EN 50103 Definition of ‘should’ and ‘may’

• Should:

– indicates that a certain course of action is preferred but not necessarily required.

• May:

– indicates a course of action often followed by established SUPPLIERS of similar ACTIVE MEDICAL DEVICCES.

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BS EN 50103: 1996

• Details additional information and GMP.

• For the benefit of the industry, suppliers, regulatory authorities, and auditors.

• They assist in the understanding and interpretation of the requirement.

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BS EN 724: 1996

• Provides guidance on the establishment and maintenance of the quality systems defined in EN 46001/2 for the manufacture of non-active medical devices.

• Seeks to assist in the transition from GMP to quality systems by presenting familiar concepts under the relevant paragraphs of EN 46001/2.

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BS EN 724: 1996

• Provides non-active medical device examples of how to meet the requirements, recognizing that other methods which achieve the same ends are equally acceptable;

• Gives general advice on how to meet the requirement;

• Draws attention to the aspects of requirements that may not be readily apparent to those unfamiliar with quality systems for non-active medical device industry.

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BS EN 928: 1996

• Intended to provide guidance to IVD manufacturers and also for certifying and regulatory bodies.

• Attempts to explain what should be done to fulfil customer needs and is not only a guide for quality assessors.

• The combination of standards embrace the principles of GMP.

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Sterilization Standards

• ISO 11134 ( BS EN 554):1994– requirement for validation and routine

control of moist heat sterilization.• ISO 11135 ( BS EN 550) :1994

– requirement for validation and routine control of ethylene oxide sterilization.

• ISO 11137 ( BS EN 552):1995– requirement for validation and routine

control of radiation sterilization

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TC 198 Sterilization of health care products

• ISO 13408-1: 1998

– Aseptic processing of health care products

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Software for Medical Devices

• EN 60601-1-4:1997 ( BS 5724 1.4:1997)

– Medical electrical equipment; part1: general requirements for safety; 4. Collateral standard, safety requirements for programmable electrical medical systems.

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Risk Analysis

• EN 1441: 1998 (BSI 96506771DC)

– risk analysis for medical devices.

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Environmental Standard

• ISO 14001:1996

– Environmental management systems -- Specification with guidance for use

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Collateral Directives

• Electrical Safety (Low Voltage Directive) (73/23/EEC)– mandatory since 1-1-1997

• Electromagnetic Compatibility (EMC) (89/336/EEC)– mandatory since 1-1-1996

• Terminal equipment (91/263/EEC)– mandatory since 1-1-1992

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CE Marking for Medical Device

A IMD Directive

(90/385/EEC)MDD Directive

(93/42/EEC)IVD Directive

98/76/EC

CE Marking Conformity Assessment

Third Party Review

Vigilance System

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Vigilance SystemManufacturers Incident

1. Inform

2. Assess

3. Review

4. Investigate

5. Action

6. Conclusion

7. Information

8. File

Competent Authority

Informed of incident

Initial assessment report

Propose/Implement action

Full investigation

Propose/Implement action

Final report issued

File report File report

Inform other European CAs

Receive or prepare final report

Informed consultation

Informed of progress

Monitor initial action

Informed by manufacturer within 10(30)days

Informed of incident

財團法人 工業技術研究院 量測技術發展中心 1999/5/141...

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財團法人工業技術研究院量測技術發展中心 1999/5/141...