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

EU Regulatory Environment—2008

Evangeline Loh, Ph.D., RACDirector Regulatory Affairs, Emergo [email protected]



Medical Devices and CE Marking in 2008


European Union in 2008

27 member states490 million23 languages




Recast of the Medical Devices Directives



Principle EU Market

• Four Freedom Principles: Movement of- Services- Capital- People- Products


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





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



Risk assessment

Notified Body

Authorized Representative andCompetent Authority registration

Vigilance system

CE Marking

Declaration of Conformity

Basic Steps to ComplianceBasic Steps to Compliance



• EU Commission Interpretative Fiche

• MEDDEV

• Manuals (Borderline and Classification Expert Group)

• NB-MED

Guidance DocumentsGuidance Documents



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



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



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



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.



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.



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


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.



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.




• 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.




• 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.




• 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.




• 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.




• 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.




• Annex VIII – Statement Concerning Devices for Special Purposes

• This Annex relates to custom made devices or devices for clinical investigation



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




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



Technical File & Design DossierTechnical File & Design DossierContains all the relevant information to demonstrate that the product meets the Essential Requirements of the Directive

=



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



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…



Notified BodyNotified Body

Third party organization appointed by a Member State to undertake prescribed activities

Commercial contracts with manufacturers

Who is responsible?



Authorized RepresentationAuthorized Representation

Authorized Representative for Europe in the event the manufacturer is not established within the EEA

Who to select? Who is responsible?



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



Post Marketing Surveillance

Required for all devices Review of market, field data, complaints,

investigation, corrective actions Systematic records kept



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



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



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



Product identification Identification of the

manufacturer Directives complied with Standards used Signature by authorized

person Language requirements

Declaration of ConformityDeclaration of Conformity


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)



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.



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




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



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



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




• Applies to medical equipment

• Excluded:• Implants and “infected” devices;• Devices designed for a voltage rating exceeding 1000

Volts AC and 1500 volts DC



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!




• Labeling Requirement – Wheelie Bin • Disposal Instruction Requirements• EN 50419



EU Device Regulations

• A Work in Progress…