歐盟對醫療器材之管理

1. 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

2. European Council Regulations • Brief in European Council Directive • CE Marking Conformity Assessment • EC Medical Devices Classification • Medical Device Standards

3. 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.

4. 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.

5. AIMD 90/385/EEC • Article 1 ~17 • Definitions and Clarification • Member States’ Responsibility • Free Marketing Policy • Custom-Made and Clinical Investigation Devices

6. MD Directive 93/42/EEC • Cover most other products. • Took effect on 1st January 1995. • A transitional period in force until 13th Jane 1998.

7. MD Directive 93/42/EEC • 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.

8. 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.

9. IVD Directive 98/79/EC • 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.

10. IVD Directive 98/79/EC • 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.

11. 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.

12. 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

13. EC Declaration of Conformity( 90/385/EEC Annex 2) • Complete quality assurance (EN 46001) • from design to final control

14. 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.

15. 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.

16. Declaration of Conformity to Type ( 90/385/EEC Annex 5) • Assurance of production quality (EN 46002) • from manufacture to final inspection.

17. 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

18. 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.

19. 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.

20. Conformity Assessment (90/385/EEC ) • 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.

21. 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.

22. 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

23. MD Directive 93/42/EEC • 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

24. EC Declaration of Conformity( 93/42/EEC Annex 2) • Full quality assurance (EN 46001) • from design to final inspection.

25. 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.

26. 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.

27. Declaration of Conformity( 93/42/EEC Annex 5) • Assurance of production quality (EN 46002) • from manufacture to final inspection.

28. Declaration of Conformity( 93/42/EEC Annex 6) • Product quality assurance • Final inspection and testing of the product.

29. Declaration of Conformity( 93/42/EEC Annex 7) • 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.

30. 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

31. Conformity Assessment (93/42/EEC ) • Class III devices: • Annex 2 ; or • Annex 3, coupled with: • Annex 4 ( EC verification); • Annex 5 (Production quality assurance).

32. Conformity Assessment (93/42/EEC ) • Class IIa devices: • Annex 7 coupled with either: • Annex 4 (EC verification); • Annex 5 (Production quality assurance) ; • Annex 6 (Product quality assurance).

33. Conformity Assessment (93/42/EEC ) • 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)

34. Conformity Assessment (93/42/EEC ) • 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.

35. Conformity Assessment (93/42/EEC ) • 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

36. 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.

37. 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.

38. IVD Directive 98/79/EC • 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

39. 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.

40. 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)

41. 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)

42. 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)

43. 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.

44. 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.

45. 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

46. 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.

47. 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.

48. Four Class Classification vs. AIMD & IVD • Active Implantable Device • Medical Devices • Class I (Low risk) • Class IIa and IIb (Medium risk) • Class III (High risk) • In Vitro Diagnostic Devices

49. 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.

50. Medical Devices Standards • EN 46001/2:1996 ( application standard ) • BS EN 724: 1995 ( guidance standard ) • Non-active medical devices. • BS EN 928: 1996 ( guidance standard ) • In vitro diagnostics. • BS EN 50103: 1996 ( guidance standard ) • Active medical devices.