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MEDICAL DEVICE COMPLIANCE The Who, What and How

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Title: MEDICAL DEVICE COMPLIANCE The Who, What and How


1
MEDICAL DEVICE COMPLIANCEThe Who, What and How
Carolyn Algar
2
What is Compliance?
  • A state of being in accordance with established
    guidelines, specifications, or legislation
  • or
  • The process of becoming so.

3
Medical Device Definition
  • A medical device is an instrument, apparatus,
    appliance, implement, machine, contrivance,
    implant, in vitro reagent, software, material, or
    other similar or related article, including a
    component part, or accessory which is
  • intended for use in the diagnosis of disease or
    other conditions, or in the cure, alleviation,
    mitigation, treatment, or prevention of disease,
    in man or other animals (US) or
  • intended to affect the structure or any function
    of the body of man or other animals, but which
    does not achieve its principal intended action in
    or on the human body by pharmacological,
    immunological or metabolic means, but which may
    be assisted in its function by such means

4
Is Software a Medical Device?
  • Software can be a device by itself (standalone),
    or it can be incorporated into another device,
    either as a component or part, or distributed
    separately for use as an accessory to another
    device.

5
Medical Device Classification
  • Class I. (low risk)
  • subjected to minimal regulation
  • Not intended to be
  • For use in supporting or sustaining life.
  • Of importance in preventing impairment to human
    life.
  • And may not present a potential unreasonable risk
    of illness or injury.
  • E.g. elastic bandages, tongue depressors, enema
    kits, band aids, gauze
  • Class II (medium risk)
  • general controls not sufficient to provide
    reasonable assurances of their safety and
    effectiveness.
  • Must meet performance standards.
  • E.g. powered wheelchairs, infusion pumps,
    surgical drapes, syringes, catheters,
    electrocardiographs
  • Class III (highest risk)
  • Most rigidly controlled.
  • General controls judged insufficient to provide
    reasonable assurances of their safety and
    effectiveness and sufficient information does not
    exist to establish performance standards.
  • Usually used to support or sustain human life,
    or substantial importance in preventing
    impairment of human health.
  • E.g. replacement heart valves, implanted
    cerebella stimulators, cardiac pacemakers,
    angioplasty balloons

6
Medical Device Classification
  • Class I General Controls
  • Most with exemptions 1
  • Few without exemptions
  • Class II General Controls and Special Controls
  • Few with exemptions 1
  • Most without exemptions
  • Class III General Controls and Premarket
    Approval
  • The higher the class, the greater the level of
    assessment

1 Except from Pre-market Notification
7
Why formalize my system?
  • Process and product/service control to ensure
    that customer specifications are consistently met
  • Legislative requirements have been met
  • Procedures are in place in the event of a product
    recall, withdrawal or a customer complaint or in
    the event that product/service non-conformance is
    identified during the production phase
  • Training procedures are established, documented
    and implemented
  • Processes and procedures are regularly reviewed
    and enhanced or improved where necessary

8
CE Marking
9
Where and What?
  • The CE Marking applies only to products placed in
    the market or put into service in the European
    Economic Area (currently 27 countries)
  • The CE Marking is required only for the following
    types of products-Toys-Machinery-Electrical
    and electronic equipment-Personal protective
    equipment-Pressure equipment-Medical
    devices-Active implantable medical devices-In
    vitro diagnostica-Simple pressure vessels
  • -Radio and Telecommunications
  • terminal equipment
  • The CE Marking is NOT required for the following
    products-Chemicals, Pharmaceuticals, Cosmetics,
    Foodstuffs

-Gas appliances-Lifts-Recreational
craft-Equipment and protective systems for use
in explosive atmospheres-Non-automatic weighing
instruments-Cableways-Construction
products-Explosives for civil use-New hot water
boilers-Measuring Equipment
10
Directives
  • CE Marking product requirements and certification
    procedures
  • Currently almost 25 CE Marking directives for
    different product groups (e.g. machinery, toys,
    medical devices) or product aspects (e.g.
    electromagnetic compatibility).
  • More than one directive can apply to a single
    product.
  • General Product Safety Directive (2001/95/EC)
    applies.

11
European Harmonized Standards
  • Product standards developed, adopted and
    published by one of the three European standards
    bodies CEN, CENELEC or ETSI
  • Content of these standards are harmonized with
    the content of the essential requirements of the
    directives to which they pertain. For every CE
    Marking directive there is a list of European
    harmonized standards.

12
Conformity assessment/Certification
  • BASICALLY there are only two types of procedures
  • 'self-certification' by the manufacturer, or
  • obligatory certification by a third party
    certification body (called 'Notified Body' or
    'Competent Body').
  • Conformity assessment may involve product
    testing, visual inspection, risk analysis, as
    well as a review of the product label and
    instructions

13
How?The Process in a Nutshell
14
Technical File
  • Every CE Marking directive requires the
    manufacturer or importer to compile and keep
    available for inspection a so-called Technical
    File.
  • The purpose of the Technical File is to provide
    documented evidence of the product's compliance.
  • The Technical File must be kept available for at
    least 10 years after the date of the last
    manufacture of the product.

15
Technical File
  • Which documentation exactly needs to be provided
    in the Technical File is stipulated in the text
    of the directives. However, mostly general
    descriptions of documents are given, and the
    directives do not specifically list the documents
    that need to be provided.
  • As a rule, the Technical File should cover the
    design, manufacture and operation of the product.

16
Technical File
  • The Technical File should contain at least all
    information about the product which allow the
    authorities to
  • identify the product
  • determine the configuration of the product that
    was approved
  • determine which standards were applied
  • determine which directives were applied
  • determine how the product meets the requirements
    of the relevant directives and standards
  • identify the manufacturer and manufacturing
    process
  • determine how the manufacturer ensures consistent
    quality of production and continuous product
    compliance

17
Technical File
  • Most CE Marking directives require a full copy of
    the Technical File to be kept in Europe.
  • A good solution is to appoint an 'Authorized
    Representative' that keeps the Technical File.
  • An Authorized Representative is strictly a
    regulatory representative, and not involved in
    the design, manufacture or sale of the products.

18
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19
Declaration of Conformity
  • Manufacturer states the fulfillment of the
    requirements of the relevant directives and
    standards.
  • Contain the references to the directives and
    standards that have been applied, a product
    specification and the contact details of the
    manufacturer.
  • The Declaration of Conformity must be signed by a
    person authorized to legally bind the company.
  • The Declaration of Conformity is kept available
    in the Technical File.

20
  • Affixing the CE Marking to a product may only be
    done by the manufacturer or his authorized
    representative.
  • Confirms that the product meets the applicable CE
    requirements.
  • Criminal offense that may be prosecuted.
  • The CE Marking must be affixed to the product
    visibly, legibly and indelibly.

21
ISO 134852003
22
What is ISO
  • ISO is the International Organization for
    Standardization.
  • Set up in 1947 and is located in Geneva,
    Switzerland.
  • Its purpose is to facilitate and support
    international trade by developing standards that
    people everywhere would recognize.

23
Why not 90012000?
  • ISO 13485 is a stand alone standard
  • It is based on ISO 90012000.
  • The Medical Device Industry did not agree with
    all the changes to ISO 90012000
  • Lacked process orientation
  • Primary objective of ISO13485 is to facilitate
    harmonized medical device regulatory requirements

24
ISO 134852003
  • A process standard not a product standard.
  • Establish a quality management system that
    is oriented towards the design, development,
    production, and installation of medical
    devices and related services.
  • Demonstrate the ability to supply medical devices
    and related services that meet customer
    expectations and comply with regulatory
    requirements.
  • Evaluate how well your organization is able
    to meet customer expectations and comply
    with regulatory requirements.

25
How do you do this?
  • In order to become certified, you need to develop
    a Quality Management System (QMS) that complies
    with the ISO 13485 2003 standard

26
Quality Management System
  • ISO 134852003 requires a minimum of 19
    procedures!
  • Quality Manual
  • 4.2.3 Control of Documents
  • 4.2.4 Control of Records
  • 6.2.2 Competence, awareness and training
  • 7.3 Design and Development
  • 7.4.1 Purchasing Process
  • 7.5.1.2 Installation activities (if applicable)
  • 7.5.1.3 Servicing activities (when required)
  • 7.5.3.1 Identification
  • 7.5.3.2 Traceability
  • 7.5.5 Preservation of Product
  • 7.6 Control of Measuring and Monitoring Devices
  • 8.1 Statistical Techniques (if used)
  • 8.2.2 Internal Audits
  • 8.3 Control of nonconforming product
  • 8.4 Analysis of Data
  • 8.5 Improvement
  • 8.5.2 Corrective Action

27
Establish, Demonstrate, Evaluate
28
FDA and the QSR21 CFR 820
29
FDA Organization
30
General Controls
  • Apply to all medical devices.
  • Considered to be the minimum requirements.
  • Register each manufacturing location
  • List all marketed devices
  • Label devices in accordance with applicable
    regulations
  • Submit a premarket notification 510(k), unless
    the device is exempt from premarket notification
    or if it identified as being subject to other
    requirements.
  • Manufacture devices in accordance with cGMP
    regulations (Current Good Manufacturing Practice)

31
Special Controls
  • Apply to Class II devices.
  • Assume that General Controls not sufficient to
    assure the safety and effectiveness of the
    device.
  • Vary from product to product. May include
  • Special labeling requirements
  • Conformance with certain FDA guidelines
  • Mandatory performance standards
  • Human clinical trials
  • Post market surveillance

32
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33
510(k) Premarket Notification
  • Most Class II devices are cleared for commercial
    distribution or marketing through this.
  • 510(k) clearance (not approval) is based on the
    being substantially equivalent to a predicate
    device
  • Usually a device marketed before MDA of 1976
    (preamendment device) or a postamendement device
    that was found to be substantially equivalent to
    a preamendment device.
  • FDA must be convinced that
  • Device performs the same function and falls
    within an established type of predicate device
  • The technological characteristics of the new
    device are comparable to the predicate device
  • Whatever differences in characteristics that do
    exist between the new and predicate device will
    not raise any new safety and effectiveness
    questions.

34
When is a 510(k) Required?
  • The device is introduced into commercial
    distribution for the first time
  • The device is in commercial distribution but is
    about to be significantly changed or modified
  • A change that could significantly affect the
    safety or effectiveness of the device
  • A major change or modification in the intended
    use of the device

35
What is required for a 510(k)?
  • General information
  • Definition of intended use in accordance with
    established product categories
  • Comparison to substantially equivalent device
  • Drawings
  • Product overview
  • Labeling
  • Truth and accuracy statement
  • Safety and effectiveness summary

36
What is required for a 510(k)? (cont.)
  • Supporting materials (attachments)
  • Design specifications (safety risk analysis,
    requirements specification, design description,
    test procedures, )
  • Conformance to recognized standards (general
    safety standards such as UL, IEC, etc.)
  • Clinical data to show performance or adherence to
    established Guidance requirements to
    demonstrate performance
  • Reference materials if a not widely recognized
    method

37
PMA Premarket Approval
  • A required process of scientific review to ensure
    the safety and effectiveness of most Class III
    devices
  • for which insufficient information exists to
    assure safety and effectiveness solely through
    general or special controls.
  • An approved PMA application is a private license
    granted to the applicant to market a particular
    medical device.
  • Submission-to-Decision time averaged 411 days in
    2001.

38
FDA Fees
39
When can You Market a Medical Device?
  • The device is exempt from premarket
    notification and has been listed with the FDA.
  • Applies to most Class I devices and a few Class
    II devices
  • The device has a clearance under the 510(k)
    program
  • Applies to most Class II devices
  • - or - the device has a pending clearance
    (FDAs Compliance guide section 300.600)
  • Although a firm may advertise a device that is
    the subject of a pending 510(k) a firm may not
    take orders that might result in contracts for
    sale unless limited to research or
    investigational use
  • The device has an approval under the PMA
    program
  • Applies to Class III devices

40
Quality System Regulations
  • 21 CFR 820

41
21 CFR Part 820
Quality System Regulations Consists of 15
subparts and 31 sections.
  • Subpart A General Provisions
  • Subpart B Quality Systems Requirements
  • Subpart C Design Controls
  • Subpart D Document Controls
  • Subpart E Purchasing Controls
  • Subpart F Identification and Traceability
  • Subpart G Production and Process Controls
  • Subpart H Acceptance Activities
  • Subpart I Nonconforming Product
  • Subpart J Corrective and Preventive Action
  • Subpart K Labeling and Packaging Control
  • Subpart L Handling, Storage, Distribution and
    Installation
  • Subpart M Records
  • Subpart N Servicing
  • Subpart O Statistical Techniques

42
The same but different
43
Setting up a Quality System
  • Plan, Document, Implement, Maintain
  • Documentation drives the whole Quality Management
    System
  • The document system is a highly controlled system

44
Document Levels
45
Examples
  • Quality Manual
  • Standard Operating Procedures
  • Document Control
  • Design Control
  • Purchasing Control
  • Equipment Control
  • Work Instructions
  • Test Reports
  • Equipment Usage
  • Forms
  • Document Change Form
  • Internal Audit Plan
  • DMRs and DHRs/batch records

46
Design Control
47
Customer Requirements, Business Requirements and
Product Requirements
DESIGN TRANSFER
Risk AnalysisTraceability Matrix
Development Project Plan
DESIGN
Plan and ProtocolInterim/Final ReportReview
Minutes and Approval
Patent DisclosuresCommercialization Plan (draft)
3lots
Design Output
Transfer ChecklistManufacturing ProceduresPilot
BuildProduct labeling MSDS
VERIFICATION
Plan and ProtocolFinal ReportReview Minutes and
Approval
VALIDATION
If requiredClinical Evaluation CE
Marking 510(k) Submission/ ClearanceCommercializ
ation Plan
Plan and ProtocolFinal ReportReview Minutes and
Approval
Final Design Review
MARKET RELEASE
48
The 1-10-100 Rule
Cost of preventing a defect before it occurs
1
Cost of correcting a defect before it reaches a
customer
10
Cost of correcting a defect after it reaches a
customer
100
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