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Copyright © 2012 BSI. All rights reserved.
Changes to the Regulation of IVDs in Europe
Copyright © 2014 BSI. All rights reserved. 2
Caution
• The new regulations are draft and subject to change
• Further details will be added later pre and post application through implementing and delegating legislation
Copyright © 2014 BSI. All rights reserved. 3
Structure of the IVDR
Chapters 10
Articles 90
Annexes 14
Annex I General Safety and Performance Requirements
• Equivalent to the current essential requirement
• Broadly similar with additional clarification
• New sections for software and requirements for use with mobile platforms
• Requirements for self tests are extended to include near patient testing
Annex II Technical documentation
• Significantly more detail regarding the expectations for technical documentation
Annex III Declaration of Conformity
Annex IV CE marking
Annex V Registration and UDI
Annex VI Requirements for Notified Bodies
Annex VII Classification
Annex VIII Conformity Assessment based on Full QA or Design Examination
Annex IX Conformity Assessment based on Type Examination
Annex X Conformity Assessment based on Production QA
Annex XI Notified Bodies Certificate content
Annex XII Clinical Evidence and Post Market Follow up
Annex XIII Interventional Clinical Performance Studies
Annex XIV Correlation table
More detailed consistent with the proposed Medical Device Regulation
Copyright © 2014 BSI. All rights reserved. 4
Copyright © 2012 BSI. All rights reserved.
When?
Copyright © 2014 BSI. All rights reserved. 5
The IVDR Approval Timeline
General Agreement
Oct 2015
Informal Agreement
June 2016
First Reading Oct 2016
Accelerated Second Reading
Adoption Q4 2016
Copyright © 2016 BSI. All rights reserved.
Copyright © 2014 BSI. All rights reserved. 6
Transitional Arrangements
Entry into force Q4 2016/ 2017
Adoption + 6 months NB can
apply for Designation
5 Year Transition
Manuf can meet IVDD or IVDR
Date of application
(DoA) 2021/22
Copyright © 2016 BSI. All rights reserved.
Class A IVDs under the IVDR can be placed
on market under IVDR
CE Certificates can be renewed during the transition
Max expiry DoA + 2 years
Copyright © 2014 BSI. All rights reserved. 7
Notified Body Designation
• Details of NB designation will be in an Implementing Act prepared in the 6 months following the Entry into Force
• The implementing acts will define the details for designation, including a joint on-site audit with the Commission and at least one additional CA
• During this 6 month period manufacturers requiring a NB and those who can self declare will not be able to place product on the market using the IVDR they will have to use the IVDD.
• It could take up to 18 months to designate all NBs
Copyright © 2016 BSI. All rights reserved.
Copyright © 2014 BSI. All rights reserved. 8
Copyright © 2012 BSI. All rights reserved.
Classification and Conformity
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Change to scope of IVDR through MDR
• ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific direct or indirect medical purposes of:
• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability,
• investigation, replacement or modification of the anatomy or of a physiological process or state,
• investigation, replacement or modification of the anatomy or of a physiological process or state,
• disinfection or sterilisation of any of the above-mentioned products,
• providing information concerning direct or indirect impacts on health,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
Impact
Tests to predict the likelihood patients will develop cancer or heart disease will be included, Life
style tests for example tests to suggest dietary changes for health reasons will be included
Copyright © 2014 BSI. All rights reserved. 10
Scope
'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, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
• concerning a physiological or pathological state;
• concerning a physical or mental impairments; In vitro diagnostic medical devices used for DNA-testing shall be subject to this Regulation
• concerning the predisposition to a medical condition or a disease;
• to determine the safety and compatibility with potential recipients;
• to predict treatment response or reactions;
• to define or monitor therapeutic measures.
Copyright © 2014 BSI. All rights reserved. 11
IVD Classification
27/04/2016
Application of the classification rules shall be governed by the intended purpose, novelty, complexity and inherent risk of the devices.
Copyright © 2014 BSI. All rights reserved. 12
Class D
• High public health risk, high personal risk
Examples
• HIV 1/2,
• Hepatitis C virus,
• Hepatitis B virus
• HTLV I/II
• CHAGAS
• Syphilis (Used to screen blood donations)
• Blood grouping ABO, Rhesus (including RHW1), Kell, Kidd and Duffy systems
Copyright © 2014 BSI. All rights reserved. 13
Class C
• High personal risk, moderate to low public health risk
Examples
• Syphilis (Used for diagnosis only)
• Neonatal screening for metabolic disorders e.g. PKU
• Rubella
• Cancer markers
• Genetic tests
• Companion diagnostics
• Blood glucose meters and strips
• Blood gas analysers
• Self tests
Copyright © 2014 BSI. All rights reserved. 14
Class B
• Moderate to low personal risk, low public health risk
Examples
• Thyroid function
• Infertility assays
• Clinical chemistry
Copyright © 2014 BSI. All rights reserved. 15
Class A
• Low personal risk, low public health risk
Examples
• Accessories
• Wash buffers
• Specimen receptacles
• Instruments
Copyright © 2014 BSI. All rights reserved. 16
Classification
• It will continue to be the manufacturers responsibility to classify devices
• The Notified Body will verify the proposed classification for every application
• There will be borderline issues so it is best to try to classify devices early and identify any issues
• The IVD Technical Group will prepare guidance
• Borderline issues will be referred to the CA of the manufacturer or AR if this is different to the NB they will consult
• If there is more than one application for a test and the manufacturers intended use is the lower classification then there must be a specific exclusion in the labelling e.g. near patient not self test, syphilis screening v self-test
Copyright © 2016 BSI. All rights reserved.
Copyright © 2014 BSI. All rights reserved. 17
Conformity Assessment Routes
27/04/2016
Copyright © 2014 BSI. All rights reserved. 18
Conformity Assessment Routes
4/27/2016
A B C D
EU Declaration of
Conformity
Annex III
Quality
Management
System Assurance
Annex VIII
Assessment of
Technical
Documentation for
each category of
device
Annex VIII 6.1
Quality
Management
System Assurance
Annex VIII
Type Examination
Annex IX
(includes Technical
Documentation)
Quality
Management
System Assurance
Annex VIII
Type Examination
Annex IX
(includes Technical
Documentation)
Assessment of
Technical
Documentation for
each generic
device class -
Annex VIII 6.1
Production Quality
Assurance
Annex X
Assessment of
Technical
Documentation for
each device
Annex VIII 6.1
Production Quality
Assurance
Annex X
For Companion
Diagnostics CA
consultation
For Companion
Diagnostics CA
consultationBatch Verification Batch Verification
All technical file reviews will be in depth BUT there is more sampling for D v C v B
Copyright © 2014 BSI. All rights reserved. 19
Sampling
Class D
• Assessment of the technical documentation
Class C
• Assessment of the technical documentation of at least one device representative per generic device group
Class B
• Assessment of the technical documentation of at least one representative device for each category of devices
Class A
• Notified Body not required unless sterile
In choosing representative sample(s) the notified body shall take into account the guidance developed and published by the MDCG
• in particular the novelty of the technology,
• the potential impact on the patient and practice of medicine,
• similarities in design, technology, manufacturing and sterilisation methods, the
• intended purpose and the results of any previous relevant assessments that have been carried out in accordance with this Regulation.
• The notified body shall document its rationale for the sample(s) taken.
Copyright © 2014 BSI. All rights reserved. 20
Sampling Plans
• All devices will now get an in depth review
• This is a significant change
• Low risk devices will get less sampling but will still receive and in-depth review
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Additional Scrutiny for Class D devices
Pre Certification
• As part of the conformity assessment a reference laboratory will test the device to the Common Specification with specific focus on sensitivity. The notified body must take this into consideration the Reference lab has 60 days to respond
Post certification
• The NB informs the Commission of all Class D certificates
• A Competent Authority or the Commission can select a file for review following concerns outlined in the IVDR
• The Commission will create an electronic document exchange system with the Notified Body
Copyright © 2014 BSI. All rights reserved. 22
Quantum Leap
Do not require a Notified
Body
80-90%
Require a Notified Body
80-90%
Require a Notified Body
Do not require a Notified
Body
IVD Directive IVD Regulation
Copyright © 2014 BSI. All rights reserved. 23
Copyright © 2012 BSI. All rights reserved.
Clinical Expectations
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Clinical Requirements
• Increased expectation for clinical requirements
• Clinical evidence is to be kept up to date during the life time of the device
The GHTF documents now in the IMDRF archive best guidance
• Clinical Performance Studies for In Vitro Diagnostic Medical Devices
• Clinical Evidence for IVD Medical Devices – Key Definitions and Concepts
• Clinical Evidence for IVD Medical Devices – Scientific Validity Determination and Performance Evaluation
CLINICAL
EVIDENCE Analytical Performance
CLINICAL
UTILITY
SCIENTIFIC
VALIDITY
Clinical Performance
Copyright © 2014 BSI. All rights reserved. 25
Scientific validity
Refers to the association of an analyte to a clinical condition or physiological state
Analytical
performance Refers to the ability of an IVD medical device to correctly detect and measure a particular analyte
Clinical performance Refers to its ability to yield results that relate to a particular clinical condition physiological state for the intended use and in accordance with target population and where applicable to the intended user
For established analytes, this may be from literature; but for companion diagnostics or novel analytes this needs to be established
Performance requirements similar to IVD Directive essential requirements
Data to support diagnostic accuracy compared to reference test; information related to expected values
Performance Evaluation
Clinical Evidence
Copyright © 2014 BSI. All rights reserved. 26
Final Summary
• This is happening and is nearing completion
• Requirements and expectations are increasing
• Understand the impact to your organisations wider regulatory landscape
• Talk to notified bodies about their plans for designation and resource
• Classify your devices
• Look at the clinical data you have, is it enough how can you get what you need?
• Discuss at management reviews
Copyright © 2014 BSI. All rights reserved. 27
Contact
Name: Sue Spencer
Title: Head IVD
Address: BSI
Kitemark Court,
Davy Avenue,
Milton Keynes, MK5 8PP, UK
Telephone: +44 (0)1908 814861
Email: [email protected]
Website: http://medicaldevices.bsigroup.com/
Copyright © 2014 BSI. All rights reserved. 28