australia | canada | china | europe | japan | united states © 2007 emergo group, inc. australia...
TRANSCRIPT
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
EU Regulatory Environment—2008
Evangeline Loh, Ph.D., RACDirector Regulatory Affairs, Emergo [email protected]
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Medical Devices and CE Marking in 2008
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
European Union in 2008
27 member states490 million23 languages
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Recast of the Medical Devices Directives
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Principle EU Market
• Four Freedom Principles: Movement of- Services- Capital- People- Products
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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 - 2006/42/EC Personal Protective Equipment - 89/686/EEC Low Voltage - 2006/95/EC Electromagnetic Compatibility- 2004/108/EC
© 2007 Emergo Group, Inc. Autralia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Basic Steps to ComplianceBasic Steps to Compliance
Within the scope of which Directive?
Classification
Conformity Assessment Route
Compliance to the Essential Requirements
Harmonized standards
Technical File
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Risk assessment
Notified Body
Authorized Representative andCompetent Authority registration
Vigilance system
CE Marking
Declaration of Conformity
Basic Steps to ComplianceBasic Steps to Compliance
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
• EU Commission Interpretative Fiche
• MEDDEV
• Manuals (Borderline and Classification Expert Group)
• NB-MED
Guidance DocumentsGuidance Documents
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
How Classification is DeterminedHow 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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
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 measuringClass I sterile and measuring
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Classification IVDD 98/79/EECClassification 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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
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.
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
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.
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Conformity Assessment RouteConformity Assessment RouteMDD 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 requiredNotified Body required
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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 IIbAnnex II (except Section 4, Design Dossier), orAnnex III plus IV, V or VI.
• Class IIIAnnex II (plus Section 4, Design Dossier), orAnnex III plus IV or V.
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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.
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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.
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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.
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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.
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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.
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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.
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
Conformity Assessment Routes
• Annex VIII – Statement Concerning Devices for Special Purposes
• This Annex relates to custom made devices or devices for clinical investigation
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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-certificationAnnex III
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Harmonized StandardsHarmonized Standards 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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Technical File & Design DossierTechnical File & Design DossierContains all the relevant information to demonstrate that the product meets the Essential Requirements of the Directive
=
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Essential RequirementsEssential 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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Risk AssessmentRisk 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…
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Notified BodyNotified Body
Third party organization appointed by a Member State to undertake prescribed activities
Commercial contracts with manufacturers
Who is responsible?
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Authorized RepresentationAuthorized Representation
Authorized Representative for Europe in the event the manufacturer is not established within the EEA
Who to select? Who is responsible?
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Authorized RepresentationAuthorized 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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Post Marketing Surveillance
Required for all devices Review of market, field data, complaints,
investigation, corrective actions Systematic records kept
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Vigilance, MEDDEV 2.12.1, Rev. 5Vigilance, MEDDEV 2.12.1, Rev. 5The 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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
CE MarkingCE Marking Implies conformance with all European
Directives Inspection Authorities Preempts all other marks for same
requirements Not a quality mark! Measurement Affixing Labeling
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
LanguageLanguage
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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
Product identification Identification of the
manufacturer Directives complied with Standards used Signature by authorized
person Language requirements
Declaration of ConformityDeclaration of Conformity
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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)
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
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.
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
OBL and PBLOriginal Equipment Manufacturer (OEM) or Original Equipment
Supplier (OES)
Own Brand Labeler (OBL) or Private Brand Labeler (PBL)
EU Commission Interpretative Document*
* http://ec.europa.eu/enterprise/medical_devices/guide-stds-directives/interpretative_fiche_obl.pdf
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
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
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
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:1. Submit your individual take back plan to the
relevant authorities2. Become a member of a collective take back system
in each Member State!
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
EU Device Regulations - WEEE
• Labeling Requirement – Wheelie Bin • Disposal Instruction Requirements• EN 50419
AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES
© 2007 Emergo Group, Inc. Australia > Canada > China > The Netherlands > United States 1.800.956.6588
EU Device Regulations
• A Work in Progress…