Changes to the Regulation of IVDs in Europe. Copyright 2012 BSI. All rights reserved.

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Eleanor Reed
5 years ago
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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 2

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 Annex IV Annex V Annex VI Declaration of Conformity CE marking Registration and UDI Annex VII Classification Requirements for Notified Bodies Annex VIII Conformity Assessment based on Full QA or Design Examination Annex IX Annex X Annex XI Conformity Assessment based on Type Examination Conformity Assessment based on Production QA 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 3

2021/22 Class A IVDs under the IVDR can be placed on market under IVDR CE Certificates can

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 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 2016 BSI. All rights reserved. 6

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. 7

9 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 9

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. 10

11 IVD Classification Application of the classification rules shall be governed by the intended purpose, novelty, complexity and inherent risk of the devices. 27/04/201 11

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 12

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 13

14 Class B Moderate to low personal risk, low public health risk Examples Thyroid function Infertility assays Clinical chemistry 14

15 Class A Low personal risk, low public health risk Examples Accessories Wash buffers Specimen receptacles Instruments 15

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. 16

17 Conformity Assessment Routes 27/04/201 17

18 Conformity Assessment Routes A B C D EU Declaration of Conformity Annex III Quality Management System Assurance Annex VIII 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 category of device Annex VIII 6.1 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 consultation Batch Verification Batch Verification All technical file reviews will be in depth BUT there is more sampling for D v C v B 4/27/

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. 19

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 20

21 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 21

22 Quantum Leap IVD Directive IVD Regulation Require a Notified Body Require a Notified Body 80-90% Do not require a Notified Body 80-90% Do not require a Notified Body 22

24 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 SCIENTIFIC VALIDITY Clinical Performance CLINICAL UTILITY 24

25 Clinical Evidence 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 25

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

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 26

27 Contact Name: Sue Spencer Title: Head IVD Address: BSI Kitemark Court, Davy Avenue, Milton Keynes, MK5 8PP, UK Telephone: +44 (0) Website: 27

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