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  • MDR With Brexit - How The Combination Is Impacting The European Medical Device Industry - Nelson

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    The combination of new Medical Device Regulations (MDR) and Brexit is impacting the European medical device industry in the following ways: 1) The new MDR requirements that take effect in 2021 are more stringent and require additional testing and compliance procedures that will be challenging for many companies to meet, especially with the deadline postponement to 2023 due to the COVID-19 pandemic. 2) Brexit adds further complications as the UK leaves the European regulatory system, meaning devices will need to comply with both UK and EU requirements which can differ. 3) Many existing devices on the EU market were approved under older and less rigorous standards, so will need to be re-evaluated and re-approved under the

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    The combination of new Medical Device Regulations (MDR) and Brexit is impacting the European medical device industry in the following ways: 1) The new MDR requirements that take effect in 2021 are more stringent and require additional testing and compliance procedures that will be challenging for many companies to meet, especially with the deadline postponement to 2023 due to the COVID-19 pandemic. 2) Brexit adds further complications as the UK leaves the European regulatory system, meaning devices will need to comply with both UK and EU requirements which can differ. 3) Many existing devices on the EU market were approved under older and less rigorous standards, so will need to be re-evaluated and re-approved under the

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    © All Rights Reserved
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    14 views26 pages

    MDR With Brexit - How The Combination Is Impacting The European Medical Device Industry - Nelson

    Uploaded by

    liesbeth alberts
    The combination of new Medical Device Regulations (MDR) and Brexit is impacting the European medical device industry in the following ways: 1) The new MDR requirements that take effect in 2021 are more stringent and require additional testing and compliance procedures that will be challenging for many companies to meet, especially with the deadline postponement to 2023 due to the COVID-19 pandemic. 2) Brexit adds further complications as the UK leaves the European regulatory system, meaning devices will need to comply with both UK and EU requirements which can differ. 3) Many existing devices on the EU market were approved under older and less rigorous standards, so will need to be re-evaluated and re-approved under the

    Copyright:

    © All Rights Reserved
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    of 26

    MDR with Brexit:

    How the Combination is Impacting the European Medical Device Industry

    Thor Rollins B.S. RM(NRCM)


    The Regulations, They Are a Changin’

    New MDRs (May 2021 is coming)


    -May 2020 deadline postponed

    New 10993-18 (2020)

    Recent ISO 10993-1 (2018)

    Feels Recent ISO 18562 (2017)

    1
    MDR is Postponed
    MDR Compliance
    Required for New Devices
    May 2017 May 2025
    or Resubmission

    All devices on market


    New MDRs Ratified May 2020 must be MDR compliant
    May 2021
    Devices submitted before May 2021
    meet their scheduled expiration date
    Some MDR Pinch Points:
    – There is no “grandfathering” provision
    – There is an expanded definition of what is considered a medical device
    – Requirement of a “Qualified Person” who is Responsible for Compliance

    2
    3
    MDR Remediation

    • It’s all about biocompatibility


    – Many devices on the market in EU were originally
    determined to be biocompatible based on history
    of clinical use
    – Outdated and limited testing methods were used
    – There are examples of patient injury because
    previous level of attention/scrutiny weren’t good
    enough

    • We can’t say “this knee is safe because it is the


    same material as that knee which has been on
    the market in the EU”

    4
    Meet Table A.1 from ISO 10993-1

    • Issued August
    2018

    • Replaced 2009
    version

    5
    ISO 10993 and RISK

    ISO 10993 is intended as a


    guidance to determine the Meaning, what is the risk of my
    potential biological risks arising materials and processes to the
    from the use of medical patient?
    devices.

    ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and


    testing within a risk management process

    6
    Biological Evaluation Plan (BEP) and Gap Assessment
    What should be included in a BEP?
    • Material Characterization
    • Suppliers
    • Patient contact
    • Specification sheets
    • Testing information on raw materials
    • Device description and categorization
    • Include pictures
    • Special Test Sample Preparations
    • Master product
    • Absorption capacity
    • Parts to include or exclude
    • Cut/don’t cut
    • Testing and risk assessments
    • Identify tests to perform based on risk to patient
    • Include conversation of areas where there is no risk
    (important if FDA asks for consideration in a particular
    area that does not apply to your specific device.)
    • Toxicological Risk Assessments

    7
    Step 2: Look at Options for Evaluations

    Device with Permanent Contact


    Tissue/bone

    Required Endpoint for Evaluation:


    • Cytotoxicity
    • Sensitization General Options to Address Risks:
    • Irritation • Written evaluation addressing
    • Material Mediated Pyrogenicity risk without testing
    • Acute Systemic Tox • Traditional biological tests
    • Subacute/Subchronic Tox • Chemistry testing followed by
    • Chronic Tox written evaluation
    • Genotox
    • Carcinogenicity
    • Implantation

    8
    Step 2: Look at Options for Evaluations

    Device with Permanent Contact


    Tissue/bone

    Required Endpoint for Evaluation:


    • Cytotoxicity
    • Sensitization General Options to Address Risks:
    • Irritation • Written evaluation addressing
    • Material Mediated Pyrogenicity risk without testing
    • Acute Systemic Tox • Traditional biological tests
    • Subacute/Subchronic Tox • Chemistry testing followed by
    • Chronic Tox written evaluation
    • Genotox
    • Carcinogenicity
    • Implantation

    9
    Step 2: Look at Options for Evaluations

    Device with Permanent Contact


    Tissue/bone

    Required Endpoint for Evaluation:


    • Cytotoxicity
    • Sensitization General Options to Address Risks:
    • Irritation • Written evaluation addressing
    • Material Mediated Pyrogenicity risk without testing
    • Acute Systemic Tox • Traditional biological tests
    • Subacute/Subchronic Tox • Chemistry testing followed by
    • Chronic Tox written evaluation
    • Genotox
    • Carcinogenicity
    • Implantation

    10
    Step 2: Look at Options for Evaluations

    Device with Permanent Contact


    Tissue/bone

    Required Endpoint for Evaluation:


    • Cytotoxicity
    • Sensitization General Options to Address Risks:
    • Irritation • Written evaluation addressing
    • Material Mediated Pyrogenicity risk without testing
    • Acute Systemic Tox • Traditional biological tests
    • Subacute/Subchronic Tox • Chemistry testing followed by
    • Chronic Tox written evaluation
    • Genotox
    • Carcinogenicity
    • Implantation

    11
    Step 2: Look at Options for Evaluations

    Device with Permanent Contact


    Tissue/bone

    Required Endpoint for Evaluation:


    • Cytotoxicity
    • Sensitization General Options to Address Risks:
    • Irritation • Written evaluation addressing
    • Material Mediated Pyrogenicity risk without testing
    • Acute Systemic Tox • Traditional biological tests
    • Subacute/Subchronic Tox • Chemistry testing followed by
    • Chronic Tox written evaluation
    • Genotox
    • Carcinogenicity
    • Implantation

    12
    Step 3: Family Groupings

    Set of Devices: Family Groupings:


    • 4 different plate sizes • Largest plate size
    • 5 different screw sizes • Largest screw size*
    • Each screw comes in two colors • Test cpTi and 316SS separately
    • Each plate available in cpTi or • Pool plates from different
    316SS suppliers
    • Each plate and screw
    equivalently available from 2 • Colored screws can be
    suppliers considered equivalent if
    colored using anodization
    • 36 line items to be considered
    • 80 different possible patient • One or two sets of parts can
    contacting configurations represent entire collection

    13
    What About GSPR 10.4 “CMRs”?

    14
    What About GSPR 10.4 “CMRs”?

    CLP Annex VI
    List of Chemicals

    REACH
    List of Chemicals

    15
    What About GSPR 10.4 “CMRs”? STEP 1: ASK INFORMATION FROM SUPPLIERS
    Are CMRs Present Above 0.1% w/w?

    YES Information on CMRs Available?


    Information on Concentration Available?
    NO
    NO Chemical characterization: ISO
    YES 10993-18
    Full digestion
    Is CMR > 0.1% w/w? Target Analysis for CMR RISK TO PATIENT
    SCREEN for CMRs, SEMI-QUANT
    YES
    Is a CMR Found Close to 0.1% w/w?
    YES NO
    RESULT: RESULT: NO
    Label Document
    RESULT:
    Evaluation
    Assess per ISO 10993-17
    Document Evaluation

    16
    How Does Brexit Impact?

    MHRA is now
    independent
    • Changes happened 01 Jan
    2021
    • MHRA is now the standalone
    UK regulator
    • MHRA will follow mostly
    the EU systems but allows
    them to regulate per their
    wims

    17
    Key Changes 2021
    MDR will not apply in Britain
    • Developing their own domestic system
    • Will engage with stakeholders
    • Recognize CE mark in Great Britain
    • New GB route and product marking

    18
    CE Marking
    To continue to have a supply of devices
    2 ½ years will recognize CE marks (30
    Jun 2023)

    Existing certificates by UK Notified


    Bodies will be recognized at GB marked
    and can be used in UK but not in the EU

    19
    UKCA Mark
    Valid from 01 Jan
    Requirements- MDD, UK approval body
    2021 and mandatory
    AIMDD, IVDD must be used.
    from 01 Jul 2023

    20
    Registration of devices in Great Britain
    Registration From Medical Devices to be Registered *
    01 May 2021 Class III medical devices
    Class IIb implantable
    Active implantable
    01 September 2021 Class IIb non-implantable
    Class IIa medical devices
    01 Jan 2022** Class I medical devices
    *Custom-made devices to eb registered in line with the risk class of the device
    **Applies only to devices that are not already required to be registered
    If manufacture is based outside the UK they need a responsible person in the UK to
    register on their behalf

    21
    UK Responsible Persons
    Required for non-UK manufactures placing devices on the BG market

    Can be an individual or company and just need to be competent

    Must be established in the UK

    The responsible person but register on behalf on the non-UK manufactures


    by grace periods.

    22
    Company Experts?
    “appropriately qualified by training
    and experience, who are able to
    interpret its requirements and judge
    the outcome of the evaluation for
    each medical device”

    23
    For More Educational Events & Resources Visit:

    Expert Lab Testing & Advisory Services Comprehensive Sterilization Solutions & Expert
    Industry-leading provider of global lab testing and Advisory Services
    expert consulting services. We perform Global leader in comprehensive sterilization
    microbiological and analytical laboratory tests solutions and advisory services. We have deep
    across the medical device, pharmaceutical, and expertise across Gamma, EO, NO2, E-Beam and
    tissue industries. X-Ray sterilization for multiple industries
    including medical device and pharmaceutical. Our
    www.nelsonlabs.com/education operations span 45 facilities in 13 countries.
    Sales@nelsonlabs.com www.Sterigenics.com/resources
    +1 801-232-6293 +1 800-472-4508

    Webinars Videos Open Houses Articles


    Seminars Whitepapers Trade Shows
    QUESTIONS?

    Thor Rollins B.S. RM(NRCM)


    trollins@nelsonlabs.com

    25

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