1. EU Regulatory Environment—2008
Evangeline Loh, Ph.D., RAC
Director Regulatory Affairs, Emergo Group
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2. Medical Devices and CE Marking in 2008
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3. European Union in 2008 27 member states 490 million 23 languages
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4. Recast of the Medical Devices Directives
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5. Principle EU Market Four Freedom Principles: Movement of Services
Capital
People
Products
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6. New Approach Directives (provide for CE Marking)
Medical Devices (MDD) – 93/42/EEC
Active Implantable (AIMDD) - 90/385/EEC
In-Vitro Diagnostics (IVDD) – 98/79/EC
Machinery Safety /42/EC
Personal Protective Equipment - 89/686/EEC
Low Voltage /95/EC
Electromagnetic Compatibility- 2004/108/EC
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8. Basic Steps to Compliance
Within the scope of which Directive?
Classification
Conformity Assessment Route
Compliance to the Essential Requirements
Harmonized standards
Technical File
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9. Basic Steps to Compliance
Risk assessment
Notified Body
Authorized Representative and Competent Authority registration
Vigilance system
CE Marking
Declaration of Conformity
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10. Guidance Documents EU Commission Interpretative Fiche MEDDEV
Manuals (Borderline and Classification Expert Group)
NB-MED
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11. How Classification is Determined
Duration of contact:
< 60 minutes Transient
< 30 days Short term
> 30 days Long term
Degree of invasiveness:
Application to body surface or into body orifice
Surgically invasive
Implantable
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12. How Classification is Determined
Degree of invasiveness
Duration of contact
Transient Class I Low risk
Short term Class Iia Medium risk
Long term Class Iib Medium risk
Long term Class III High risk
Class I non sterile and non measuring
Class I sterile and measuring
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13. Classification IVDD 98/79/EEC
Annex II, List A
Annex II, List B
Self-test, Annex III, Section 6
Self-certify or self-declaration, Annex III
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14. Annex II, List A
Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell,
reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.
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15. Annex II, List B
- Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd,
- reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies,
- reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis,
- reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria,
- reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia,
- reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B,
- reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA,
- reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21,
- the following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar.
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16. Conformity Assessment Route
MDD 93/42/EEC
Class I (sterile and measuring)
Class IIa, Class IIb, Class III
IVDD 98/79/EC
Annex II, List A and List B
Self-Test, Annex III,
Notified Body required
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17. Conformity Assessment Routes MDD 93/42/EEC
Class I – Non-Sterile, Non-Measuring Annex VII
Class I - Sterile or Measuring Annex VII and Annex IV, V or VI.
Class IIa Annex II (except Section 4, Design Dossier), or Annex VII plus IV, V or VI.
Class IIb Annex II (except Section 4, Design Dossier), or Annex III plus IV, V or VI.
Class III Annex II (plus Section 4, Design Dossier), or Annex III plus IV or V.
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18. Conformity Assessment Routes
Annex II – EC Declaration of Conformity (Full quality assurance system)
Class I (Sterile and Measuring), IIa, IIb and III manufacturers can choose to follow Annex II and implement a full quality system that covers all classes of products.
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19. Conformity Assessment Routes
Annex III – EC Type Examination
Class IIb and III manufacturers can elect to have a Notified Body do an audit using a representative sample of the company’s production to ascertain compliance with the directive. Used when Annex II is not the preferred route to compliance. Annex IV, V or VI must be used in conjunction with Annex III.
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20. Conformity Assessment Routes
Annex IV – EC Verification
Requires the manufacturer to meet the applicable requirements of the MDD and other technical specifications.
The Notified Body can sample up to 100% of the products, or may do statistical batch testing. If batch testing is done and accepted by the Notified Body, all products in the batch can bear the CE Marking.
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21. Conformity Assessment Routes
Annex V – EC Declaration of Conformity (Production quality assurance)
This is much the same as Annex II but without design inspection. Often used by companies that manufacturer Class I sterile/measuring and Class IIa, and those that do not design their own products.
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22. Conformity Assessment Routes
Annex VI – EC Declaration of Conformity (Product quality assurance)
This route is used by manufacturers of devices whose relevant properties can be determined during a final inspection. This means that this route to compliance cannot be used for devices that require special manufacturing processes such as sterilization. A Notified Body inspection is required.
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23. Conformity Assessment Routes
Annex VII – EC Declaration of Conformity
Requires the manufacturer to compile a Technical File and conduct a risk assessment. Used by Class I non-sterile, non-measuring device manufacturers to self–certify their products. If the Class I device has a Sterile or Measuring function, Annex V may also apply.
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24. Conformity Assessment Routes
Annex VIII – Statement Concerning Devices for Special Purposes
This Annex relates to custom made devices or devices for clinical investigation
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25. Conformity Assessment Routes IVDD 98/79/EC
Annex II, List A Annex IV or Annex V and Annex VII.
Annex II, List B Annex IV or Annex V plus Annex VI or Annex VII.
Self-test Annex III, Section 6 or procedures for Annex II, List A or Annex II, List B.
Self-declaration or self-certification Annex III
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26. Harmonized Standards Conformity to Standard
Harmonized European Standards
“Voluntary” application of Standards
Presumption of Conformity (Article 5, MDD and IVDD)
Conformity to Standard
Conformity to Essential Requirements
Hierarchy of Standards:
> Harmonized – published in the Official Journal
> EN
> ISO
> National (BS, DS, DIN, ASTM)
> Industry-specific
> Local, company-specific
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27. Technical File & Design Dossier
Contains all the relevant information to demonstrate that the product meets the Essential Requirements of the Directive =
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28. Essential Requirements
General requirements
Design & construction requirements
Chemical, physical and biological properties
Infection and microbial contamination
Construction and environmental properties
Information supplied by the manufacturer on the label and in the instructions for use
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29. Risk Assessment ISO 14971:2007 is used to:
Identify the product and describe the intended use
Characteristics which could affect safety
Identify possible hazards
Estimate the risk, and…
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30. Notified Body
Third party organization appointed by a Member State to undertake prescribed activities
Commercial contracts with manufacturers
Who is responsible?
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31. Authorized Representation
Authorized Representative for Europe in the event the manufacturer is not established within the EEA
Who to select?
Who is responsible?
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32. Authorized Representation
Listed on the label and/or packaging
Name of the manufacturer and the device must be notified to the Competent Authority
Keeps the Technical File available for review by Competent Authorities
Plays an essential role in vigilance procedures and Post-market Surveillance
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33. Post Marketing Surveillance
Required for all devices
Review of market, field data, complaints, investigation, corrective actions
Systematic records kept
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34. Vigilance, MEDDEV 2.12.1, Rev. 5 The manufacturer must:
Institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and;
Implement appropriate means to apply any necessary corrective actions
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35. CE Marking Implies conformance with all European Directives
Inspection Authorities
Preempts all other marks for same requirements
Not a quality mark!
Measurement
Affixing
Labeling
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36. Language
Member States required the labeling information to be in their official language
23 languages to date – will increase as new Member States join the EU
Label copy should only appear in one language in the Technical File
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37. Declaration of Conformity
Product identification
Identification of the manufacturer
Directives complied with
Standards used
Signature by authorized person
Language requirements
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38. Registration or Notification
Class I, AR register where they are established
(MDD 93/42/EEC, Article 14.1)
Member states latitude to transpose the directive to require “to be informed of all data allowing for identification” Class IIb and III
All IVDDs need to be registered in member states where they are to be marketed, including where the AR is established (IVDD 98/79/EEC, Article 10.6)
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39. Certificate Free Sale (CFS)
Issued by the member state’s Competent Authority or Ministry of Health to their member state-based manufacturers (or Authorized Representatives) for all devices which possess CE Marking including Class I self-certified medical devices or in vitro diagnostics devices. Each CFS can only reference one country, but there is no limit to the number of devices listed.
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40. OBL and PBL
Original Equipment Manufacturer (OEM) or Original Equipment Supplier (OES)
Own Brand Labeler (OBL) or Private Brand Labeler (PBL)
EU Commission Interpretative Document* *
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41. EU Device Regulations – Green Dot
Packaging Packaging Waste Directive 94/62/EC
German Green Dot Program
Licensed to Pro-Europe – other national organizations
“Green Dot”
Current Membership
28 European Countries
Alliance: UK, The Netherlands, Italy
Other: Canada
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42. EU Device Regulations – Green Dot
National Organization are Non-profit – pays regional / local waste management companies
Green Dot licenses – applied in each country
License fees determined on the basis of materials, weight and number of units
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43. EU Device Regulations - WEEE
Waste Electrical and Electronic Equipment Directive (WEEE)
Into effect August 2005
Aims to reduce electrical and electronic waste through collection, recovery, recycling and treatment of electrical products at the end of their useful life
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44. EU Device Regulations - WEEE
Applies to medical equipment
Excluded:
Implants and “infected” devices;
Devices designed for a voltage rating exceeding 1000 Volts AC and 1500 volts DC
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45. EU Device Regulations - WEEE
Producer pays principle
Producer prepare data on their device – instructions for recycle and disassembly and locations of dangerous substances
Producer responsible for take back - Two options:
Submit your individual take back plan to the relevant authorities
Become a member of a collective take back system in each Member State!
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46. EU Device Regulations - WEEE
Labeling Requirement – Wheelie Bin
Disposal Instruction Requirements
EN 50419
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47. EU Device Regulations A Work in Progress…
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