The IVDR 2017/746 a Notified Body view on major changes and the designation process - 04_AWMF Symposium TÜV Rheinland ...
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The IVDR 2017/746 a Notified Body view on major changes and the designation process AWMF Symposium TH Lübeck, 28.02.2020
Whom are you listening to?
Ms. Katja Mierisch
Deputy Global Head Technical Competence Center IVD,
Certification Officer
Phone: +49 (0)221/806-2563
E-Mail: katja.mierisch@de.tuv.com
Agenda
Timelines and designation
Competency requirements
Conformity Assessment / Sampling of Tech Doc
Technical Documentation
Recommendations
Overview – Designation of Notified Bodies (NBs)
Designation process ongoing:
Currently 3 NBs (BSI UK, BSI BV, DEKRA GmbH)
Limited resources of EU Com and national CA (JAT teams)
May 5th 11/2017 09/2019 Q2/2020 05/2022
2017
Presumed designation of TÜV
Regulation 2017/746 Rheinland under IVDR
published in Official Journal Designation of TÜV
of EU Rheinland under MDR Date of
Application IVDR
Delegating act published for
the designation of NBs
(“NBOG Codes”)
Impact on NBs
Increased
Extended Designation
ressource
competencies
needs
Global recruiting strategy Coverage of „NBOG Codes“
Impact on NBs - Strategy
Global Involvement Designation
Analysis of Internal of external
recruiting of + service
existing development (clinical)
new experts /
competence
auditors
of experts experts provision
Establishment of
Global competence Technical Competence Center IVD: strategic
Ongoing globally
analysis partnership with
Tasks, e.g.:
Global harmonization of technical laboratory network
competence
Provision of trainings and technical
guidance
Participating in relevant
committees, working groups and/or
associations
Preparation of designation Global project team established within TÜV Rheinland to implement IVDR requirements and to prepare a reliable application for designation Participation in Notified Body working groups („Team NB“ / „VdTUEV“) Subgroup for CDx headed by TÜV Rheinland (with participation of EMA representatives) MDCG IVD working group (TÜV Rheinland invited as permanent participant) Stakeholder meetings with manufacturer associations (eg. VDGH / MedTech Europe) Close contact to (designating) authorities through EK-MED, NB-MED 7 05.03.2020 Bitte Fußzeile einfügen
IVDR, implementing regulation (EU) 2017/2185 „NBOG Codes“ – competency codes I. Codes reflecting the design (analyte) and intended purpose of the device IVR: These product codes should represent all devices in the scope of the IVDR (33) II. Horizontal codes (areas and technologies): IVS: In vitro diagnostic devices with specific characteristics (10) IVT: In vitro diagnostic devices for which specific technologies are used (11) IVP: In vitro diagnostic devices which require specific knowledge in examination procedures (14) IVD: In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification (12) 8 3/5/2020 Please insert footnote
Assignement of codes to the assessment activities IVDR
Product Specialist
Audits (QMS part) (TD assessments)
IVT: In vitro diagnostic devices for which specific IVR: These product codes should represent all devices
technologies are used in the scope of the IVDR
IVS: In vitro diagnostic devices with specific IVS: In vitro diagnostic devices with specific charact.
characteristics (IVS1004 / 1005 / 1009 only)
IVP: In vitro diagnostic devices which require specific
knowledge in examination procedures
IVD: In vitro diagnostic devices which require specific
knowledge in laboratory and clinical disciplines for the
purpose of product verification
9 3/5/2020 Please insert footnote
IVDR, implementing regulation 2017/2185 IVR : Codes reflecting the design (analyte) and intended purpose of the device 10 3/5/2020 Please insert footnote
IVDR, implementing regulation 2017/2185 IVR : Codes reflecting the design (analyte) and intended purpose of the device Examples: 11 3/5/2020 Please insert footnote
IVDR, implementing regulation 2017/2185 IVP: In vitro diagnostic devices which require specific knowledge in examination procedures 12 3/5/2020 Please insert footnote
Overview MDCG Guidance documents, examples Link to all MDCG guidances: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en Guidance on sampling of Class B / Class C devices for the assessment of the technical documentation: MDCG 2019-13 UDI (Unique Device Identifier): 9 guidances published Qualification and classification of software: MDCG 2019-11 Guidance on article 15 ‘person responsible for regulatory compliance’ (PRRC): MDCG 2019-7 Guidances on EUDAMED: MDCG 2019-4 + MDCG 2019-5
Classification
IVD Directive IVD Regulation
List A: high risk IVDs Annex VIII
(e.g. blood donor screening, HIV,HCV)
Rule based classification system (7 rules)
List B: moderate risk IVDs Origin GHTF model
(e.g. prenatal markers, infectious diseases)
4 risk classes: A, B, C and D
IVDs for self-testing
(lay users)
“other IVDs”Classification
Impact of new classification
2017 2022
IVDs under “Self-declared” IVDs
NB conf. assessment (other IVDs)
“Self-declared” IVDs IVDs under
(other IVDs) NB conf. assessmentConformity Assessment procedures
Self declaration (Annex II)
Class A
(except for sterile devices)
QMS + Review of the Technical Documentation
Class B
Annex IX
Type Examination
QMS + Review of the Technical
Notified Body
Class C Annex X +
Documentation
QMS production
Annex IX
Annex XI
Type Examination
QMS + Technical Annex X +
Class D Documentation + QMS production
Batch release Annex XI+
Annex IX Batch release
Annex IXConformity Assessment – Class B + C (Annex IX)
QMS – on-site audits Unannounced audits
Based on EN ISO 13485
randomly, at least every 5 years
• Audit team to be experienced with
„technology concerned“
/ devices (class C)
NoBo shall test product
sample (drawn from warehouse
• a lead auditor shall not lead [and and market)
attend] an audit for more than three
consecutive years
• NB may carry out or ask for
product testing
• Surveillance Audits at least once
every 12 monthsConformity Assessment – Class B + C (Annex IX)
Tech. Documentation Review Class B / C
AllSubmitted
evidencesfor NoBo review: to Annex II and III to be submitted
according
Information on device groups
Draft DoC
special review focus: NB has to establish a sampling plan
QMS documentation
• Clinical Evidence as documented in the performance
! covering the „range“ of devices
evaluation report For class B based on „product categories“
For class C based on „generic device
• benefit-risk determination, the risk management groups“
• the instructions for use
• manufacturer's post-market surveillance plan, and include a
review of the need for, and the adequacy of, the PMPF
NoBo issues TD assessment
reportConformity Assessment – Class B + C (Annex IX)
Sampling Tech. Documentation Class B / C
Number of TDs to be reviewd by NBs will increase significantly
! Important for transition plans and cost estimations of manufacturersConformity Assessment – Class C (Annex IX) European nomenclature on medical devices 20 05.03.2020 Bitte Fußzeile einfügen
Conformity Assessment – Class D (Annex IX)
QMS – on-site audits Tech. Documentation Review – Class D
Unannounced audits Submitted for NoBo
assessment review:
of TD by NoBo for the device
Information on device groups
concerned,
Draft DoC incl:
Basically as stated before Design + manufacturing information
QMS documentation
Clinical evidence / performance
Risk benefit
NoBo issues TD assessment
report and certificateConformity Assessment – Class D (Annex IX)
Batch release Verification by reference lab
• QC reports provided to NoBo • Designated reference laboratory:
• Verification of claimed
• Batch release testing by performance
reference laboratory • Compliance with CS
• Timeline: 30d after reception of • Laboratory tests mandatory,
samples focusing on:
analytical sensitivity
diagnostic sensitivity
Timeline: 60d
NoBo shall give „due consideration“Conformity Assessment – Specific Aspects (Annex IX)
Tech. Documentation Review for CDx
TD Assessment at NB
Consultation phase - NB with Competent Authority for medicinal
Submitted
product forEMA):
(e.g. NoBo review:
- Information on device
groups of draft “summary of safety and performance” report and
Submission
- Draft DoC
the draft instructions for use
- QMS documentation
Defined timelines for feeback (60d per review round)
NoBo issues EU technical
documentation assessment
certificateConformity Assessment – Specific Aspects (Annex IX)
Tech. Documentation Review for self testing devices and POCT
TD Assessment, applicable to class B,C and D
Focus: design and performance including:
- where practicable provision of a sample of the device
Submitted for NoBo review:
- - data
Information
showingonthedevice
suitability of the device in view of its
groups
intended purpose for self-testing or near patient-testing (lay-
- user
Draftstudy)
DoC ;
- QMS documentation
- the information to be provided with the device on its label and
its instructions for use.
NoBo issues EU technical
documentation assessment
certificateTechnical Documentation Requirements as per Annex II 1. Device Description and Specification, including variants and accessories e.g. including: • product or trade name and a general description • UDI device identifier • intended purpose / Classification details • Testing population / Target population (CDx only) • Description of active incredients (e.g. antibodies, primers) 2. Information supplied by the manufacturer e.g. including: • labelling • IFU
Technical Documentation
Requirements as per Annex II
3. Design and Manufacturing Information
e.g. including:
• Information to support the understanding of design stages, such as:
• Critical ingredients: antigens, AB, primers
• Manufacturing information, such as:
• Manufacturing processes
• Manufacturing sites involved, including suppliers and sub-contractors
4. General Safety and Performance Requirements
General demonstration of conformity with the general safety and performance:
• Layout of applicable requirements / harmonized standards / CS
• precise identity of the controlled documents offering evidence including cross-reference to the actual location within the
TDTechnical Documentation
Requirements as per Annex II
5. Risk / Benefit Analysis and Risk Management
Evidence for fulfillment of respective requirements of Annex I
6. Product Verification and Validation
Including:
• Analytical performance characteristics
• Clinical performance and clinical evidence
• performance evaluation report, reports on the scientific validity, the analytical and the clinical performance
• Documents shall be included and/or fully referenced
• Stability
• Software verification and validationClinical Evidence
Definition:
clinical data and performance evaluation results …. allow a qualified assessment of whether the device
is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer
Clinical Scientific Analytical Clinical
validity performance performance
EvidenceClinical Evidence
Clinical Scientific Analytical Clinical
validity performance performance
Evidence
Very detailed requirements defined which data to be compared and which sources are to utilized
! (including specifics for plans and reports)
! Level of clinical evidence required and data source to be utilized might depend on risk class, novelty or
complexity of the device
! „State of the art“ for the device in question has to be defined in the performance evaluation planRecommendation o Carry out a gap analysis for the products affected (Clinical Evidence / Technical Documentation) o Update your quality management system processes (e.g. PMS, Vigilance, Risk Management) o Apply for a Basic UDI-DI according to article 110 point 10. IVDR (GS1, HIBCC and ICCBBA) ! o Classify your products, product lists o Group your products (one TD for every device (i.e. Basic UDI-DI)) o Establish a transition plan o Get in touch with your Notified Body to discuss transition scenarios (e.g. legacy products) and timelines o TD review first (i.e. an IVDR audit can only be planned if the TD is OK)
Thanks for your attention
Ms. Katja Mierisch
Deputy Global Head Technical Competence Center IVD,
Certification Officer
Phone: +49 (0)221/806-2563
E-Mail: katja.mierisch@de.tuv.comOverview In-house products (Article 5.5) General safety and performance requirements set out in Annex I are applicable as well However no conformity assessment Defined prerequisites, e.g.: • devices manufactured and used only within health institutions • the device is not transferred to another legal entity • Does not apply to products manufactured on an industrial scale • manufacture and use of the device occur under appropriate quality management systems • the health institution justifies in its documentation that the target patient group’s specific needs cannot be met or cannot be met at the appropriate level of performance by an equivalent device available on the market
Overview Definitions (Chapter I / Article 2) 'in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system,…….., solely or principally for the purpose of providing information: • concerning a physiological or pathological process or state • concerning congenital physical or mental impairments • concerning the predisposition to a medical condition or a disease (e.g. genetic test) • to determine the safety and compatibility with potential recipients • to predict treatment response or reactions (Companion Diagnostics (CDx)) • to define or monitor therapeutic measures 'companion diagnostic' means a device which is essential for the safe and effective use of a corresponding medicinal product…. ‘device for near patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional
Overview Article 15 - Person responsible for regulatory compliance Manufacturers shall have available within their organisation, at least one person responsible for regulatory compliance who possesses the requisite expertise…. • University degree in a relevant scientific discipline + 1 year professional experience in RA or QMS for IVDs • or 4 years professional experience in RA or QMS for IVDs Responsible to ensure: • Conformity of the device in accordance with the quality management system • Technical Documentation and the declaration of conformity are drawn up and kept up-to-date • Post-market surveillance obligations fulfilled • Reporting obligations as part of the vigilance system
Classification
Article 47 and Annex VIII:
Rule 1 Rule 2 Rule 3
Screening assays Infectious disease
(transmissible agents) blood grouping
STIs
life-threatening tissue typing
disease Cancer
Compatibility
high risk of Testing CDx
N N N
propagation
Genetic testing
Viral load
Congenital testing
Y
Drug monitoring
Specific blood
grouping
Y Y
Y N
Class D Class D Class C Class CClassification
Article 47 and Annex VIII:
Rule 4 Rule 5 Rule 6 Rule 7
Self-testing General lab use
devices Accessories
controls without a
Instruments None of the quantitative or
N N Devices before N qualitative
Specimen assigned value
Recepticals
Y
Non-critical
(e.g. pregnancy)
Y Y Y
Y N
Class B Class C Class A Class B Class BOverview Implementation status IVDR corrigendum published on 2019-03-13 • mainly minor corrections • reference to “ISO 20916 on clinical performance studies using specimens from human subjects” included • clarification made concerning TD assessments and surveillance activities of class B devices • wording changed concerning NB´s approach for sampling of TDs CAMD MDR/ IVDR Roadmap • Steps and priorities of activities outlined EC: IVDR Implementation rolling plan (latest update August 2019) • Designation of EU reference laboratories: Q4 2019/Q1 2020 • Implementing act on EUDAMED: postponed to May 2022 • Implementing Act on Common Specifications for IVD Class D: Q4 2019
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