Underwriters Laboratories Inc Getting Medical Products into the EU It by batmanishere

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									                          Underwriters Laboratories, Inc.


Getting Medical Products into the EU




    It’s not all about Product Safety
             October 26, 2004
                                Working for a safer world
                                 Underwriters Laboratories, Inc.


Overview

 Background on device regulations in the EU
 Content of MDD and how it differs from other
directives
 Steps to CE marking
 Role of supporting documentation
 Notified Bodies
 ISO 13485 and the role it plays in the EU and other
markets
                                       Working for a safer world
                                          Underwriters Laboratories, Inc.


                     Amanda Pack
  Medical Devices Primary Reviewer – West Coast Division,
Underwriters Laboratories, Santa Clara Office
  Primary Technical Contact for Medical Device conformity assessment
services, including ISO, CMDCAS, and CE according MDD and/or IVDD
  Quality System Auditor for ISO 13485, ISO 9001, CMDCAS, MDD,
IVDD
  CE Technical File Assessor
  Lead Instructor for UL’s Technical Seminars, IEC 60601-1 and ISO
13485
  Project Handler and Reviewer for IEC 60601-1 and IEC 61010-1
  FDA 510(k) Third Party Reviewer
  BS Biological Systems Engineering, University of California, Davis


                                                 Working for a safer world
                              Underwriters Laboratories, Inc.


            Background


Device Regulations in the EU

New Approach Directives




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EU


                             Uniform rules
                               for all 18
                                 (+10)
                               EU and EEA
                                countries


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EU Regulatory Structure
                European Commission
                      DGIII D2




      United Kingdom            All other member states




     Secretary of State              Secretary of State


   Medical Devices Agency           Competent Authority


       Notified Body                   Notified Body
          UL-UK

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   New Approach Directives

Free trade
Common requirements
Intervention by Notified Bodies




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       Medical Directives

Medicinal Products (65/65/EEC)
Active Implantable Devices (90/385/EEC)
Medical Devices (93/42/EEC)
In Vitro Diagnostic Medical Devices
(98/79/EC) IVDD



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            Other Directives

Low Voltage Directive (LVD) - 73/23/EEC

Safety of Toys - 88/378/EEC

Construction Products - 89/106/EEC

Electromagnetic Compatibility - 89/336/EEC

Non-automatic Weighing Instruments - 90/384/EEC


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               LVD

Adopted 19 February 1973
Revised in 1993




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          MDD Directive

Adopted 1 July 1994
In force since 1 January 1995




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              Directives

Structure

Definitions

References to Harmonized Standards

Conformity Assessment Routes
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              Structure

Recitals (policies)

Articles (laws)

Annexes (how to)



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Definitions




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           “medical device”

Any instrument, apparatus, appliance, material or
other article, whether used alone or in combination,
including the software necessary for its proper
application intended by the manufacturer to be used
for human beings for the purpose of
    -diagnosis, prevention, monitoring, treatment or
           alleviation of disease or compensation for
           an injury or handicap
    -investigation, replacement or modification of the
           anatomy or of physiological process
    -control of conception

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   “authorised representative”

Established in the EU community
Designated by the manufacturer
Assumes the manufacturer’s obligations
under the Directive




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          “manufacturer”

The legal person with responsibility for the
design, manufacture, packaging and labelling
of a device before it is placed on the market
under his own name regardless of whether
these tasks are performed by the
manufacturer himself or a third party




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        “intended purpose”


That which you claim on labels, Instructions
For Use and promotional material




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Reference to standards (Article 5)

Basically says that if you comply with the
harmonised standard then there is a
presumption of conformity with the relevant
essential requirements described by Annex I




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Conformity Assessment Procedures

Defines the routes to CE marking
dependent on product categories.




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   Steps to CE Marking - MDD

Step 1 - Is it an MDD/IVD device?
Step 2 – Classification
Step 3 - Conformity Routes
Step 4 - Essential Requirements (Annex I)
Step 5 - Declaration of Conformity
Step 6 - Affixing the CE Mark
Step 7 - Register with CA
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Step 1 – Is it an MDD device?

Review the definitions to determine if the
scope of the directive covers your device.

          Antiseptic Band-Aid
         Blood Glucose Test Strip

          Glasses



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      Step 2 – Classification
Different for each directive

MDD classification can be very complex
   Annex IX contains the rules for classification
   Guidance document,
   MEDDEV 2.4/1 Rev. 8, July 2001
   When in doubt you should confirm with your
   Notified Body and possibility with the
   Competent Authority

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  Step 3 - Conformity Routes


Based on Modules:

  Design

  Quality Assurance

  Testing

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                                                                    NB intervention
                                      Annex                         required?
                                       IX
                                                                        No    Yes
                                                      Class IIa,
Class I           Class Is, Im, IIa
                                                       IIb, III

          Annex            Annex              Annex          Annex II
           VII              VII                III             EN
                                                              13485




                     Annex            Annex     Annex V
                      IV               VI         EN
                                       EN        13488
                                      46003                              See MDD,
                                                                         Article 11
                                                                         for full
                                                                         details
                                              Underwriters Laboratories, Inc.


Step 4 - Essential Requirements (Annex I)

    Need to consider every requirement, although not all may be
    relevant to your product

    You need to justify why particular requirements are not relevant

    Cross reference your technical documentation in an Essential
    Requirement checklist

    Presume compliance with Essential Requirements if Harmonized
    Standards used (Article 5)

    If Harmonized Standards not used, must justify and show
    equivalent level of safety

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Essential Requirements (Annex I)

Harmonized Standards:
 EN/ISO13485- Quality systems medical devices
 EN 13612 Performance evaluation
 Common technical specifications
 EN 13640 Stability testing
 EN 14971 Risk analysis
 EN 375 Information supplied by manufacturer
 EN 591 Instructions for use
 EN 1658 Marking requirements
 EN/IEC 60601-1 Product safety
 Others applicable and in preparation
    www.newapproaches.org/directivesList.asp
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Step 5 - Declaration of Conformity

The EU entity (manufacturer or Authorized
Representative) must draw up the
Declaration of Conformity.
It must contain all the information required
to identify the directives, the manufacturer,
the notified body, the product, the
standards.
You must keep it for 5 years after the last
product has been manufactured.
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  Step 6 - Affixing the CE Mark

The CE Mark must be visible, legible and indelible
on the device and IFU.

Where a notified body was involved, the notified
body number must accompany the CE Mark.

Misleading third party marks are not permitted.



                                           0843
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    Step 7 - Register with CA

You must provide information to the Competent
Authority in the Member State in which you have
your registered place of business as follows:
  Address
  General Device Information (all devices)
     Analytical/Diagnostic Parameters
  Performance Evaluation Outcomes (Annex VIII)
  Labelling Information (List A & Self Test
  required by some Competent Authorities)
BUT…
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    Step 7 - Register with CA

Currently you must register with the
Competent Authority of each Member
State of the EU in which you intend to
supply product!

For the Competent Authority in the UK for
example, see:
http://www.medical-devices.gov.uk

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Role of Supporting Documentation



Technical Files




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            Technical Files

Technical Documentation - Requirements

  Prepare documentation

  Make available

  Review

  Keep up to date

Even if no NB involved you still need to have

documentation available. 33
                       Slide
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     Role of Supporting Documentation
     Types of Technical Documentation - MDD
1.   General description               9.     Design calculations and
2.   Quality system information               inspections
3.   Design information                10.    If combined with other
                                              devices, combinations
4.   Essential Requirements
                                              meets essential
     checklist
                                              requirements
5.   Descriptions, including
                                       11.    Test reports – Product
     operation
                                              Safety & EMC
6.   Risk analysis
                                       12.    Performance data
7.   Harmonised standards used
                                       13.    Labels and instructions for
     to meet essential
                                              use
     requirements
                                       14.    Clinical Data – Studies or
8.   Sterility and Biocompatibility
                                              Reports
     studies/validations           Slide 34
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 Role of Supporting Documentation
Typical types of Technical Documentation - LVD
1. General description
2. Design and manufacturing drawings
3. Descriptions of drawings and the operation
   of the device
4. Harmonised standards used to meet
   requirements
5. Results of design calculations made,
   examinations carried out
6. Test reports – Product Safety & EMC
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          Notified Bodies

 What are they

 What roles do they play
in CE marking

 Important issues when
selected a NB
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   Notified Body Requirements


Registered with the Competent Authority (CA)
in the country where they are located

Undergo annual audits by CA to ensure
compliance with the NB requirements

Must be on EU soil

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      Roles of a Notified Body

Controls your legal market access to EU
market

Typically min. 3 year relationship

Assesses and certifies conformity to selected
conformity path

Only for higher risk devices
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     Criteria for NB Selection

Expertise
   Match with key hazards of your device, and your
   selected conformity assessment route
Responsive to your needs
   Identifies any concerns early
   Accessible as you work through concerns
Track record
One-stop for other needed service
   FDA 510(k), safety testing, EMC testing, ISO and
   CMDCAS
Cost
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           ISO 13485


What is ISO 13485

Why is it needed

How does it fit into worldwide
certification schemes
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       What is ISO 13485

Medical devices – Quality management
systems – Requirements for regulatory
purposes
 “specifies requirements for a quality
 management system where an organization
 needs to demonstrate its ability to provide
 medical devices and related services that
 consistently meet customer requirements
 and regulatory requirements applicable to
 medical devices”
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     Why is ISO 13485 needed

Different conformity assessment paths in the
MDD require Quality Systems
  EN/ISO 13485 is a harmonized standard that can be used to
  meet this requirement

When using ISO 13485 the following directive specific
requirements should be included:
  Risk management and ER as design inputs
  Verification and Validation methods
     Use of harmonized standards (or alternatives)
  Production procedures and controls
  Post market surveillance and vigilance
  Language translations
                          Slide 42
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     ISO 13485 - Worldwide

How does ISO 13485 fit into worldwide
certification schemes




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        Global Regulatory Structure

                                 Global compliance


  USA                                  Europe                                            Canada


21CFR820                         In Vitro Diagnostic                                  Medical Device
21CFR800                            MDD or IVDD
                                       Directive                                       Regulations
                                         IVDD                                             MDR


  QSR                                 ISO13485                                       CMDCAS/ISO13485


  Various     EN13612         EN375               EN14971           EN13640               Various
 guidance   Performance       IFU for           Risk analysis    Stability Testing       guidance
documents    evaluation    IVD reagents                                                 documents


                               EN 591                                EN13641
                               IFU for                            Infection Risk
                          IVD instruments                           Reduction

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Japan’s New Regulatory Structure


Will be in effect as of 1 April 2005

Requires ISO 13485:2003

Will have components similar to CE and
CMDCAS schemes.

                   Slide 45
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Questions?




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Contact Information


 Amanda Pack
 Amanda.g.pack@us.ul.com
 (408) 876-2756 - Phone
 (408) 556-6222 - Fax



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