IVD Regulatory Update February 2015

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Milo Douglas
6 years ago
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Content IVD proposals Expected timelines Impacts: Re-classification

website New harmonised standards list EN980 has been reinstated onto

3 On the move The IVD Directive has moved from Enterprise and Industry Many documents are on the move to the Growth part of the Commission website New harmonised standards list EN980 has been reinstated onto the harmonised standards list Copyright 2015 BSI. All rights reserved. 3

Timeline Regulations have direct entry into force upon publication No transposition period, as for a Directive Transition period currently being negotiated for 5 years for IVDs Additional

4 Timeline Regulations have direct entry into force upon publication No transposition period, as for a Directive Transition period currently being negotiated for 5 years for IVDs Additional implementing acts will be needed after the Regulation is published Implications for Manufacturers and Notified Bodies Guidance may not be issued until after the implementing acts have been published Copyright 2015 BSI. All rights reserved. 4

5 IVDR Timeline - Realistic expectation Greek Presidency Italian Presidency Latvian Presidency Council reaches general approach? Luxembourg Presidency Dutch Presidency Jan 2014 July 2014 Jan 2015 July 2015 Jan 2016 Parliament elections Parliament 1 st reading Rapporteurs appointed New Commissioners in place Begin trilogues? Conclude trilogues? Entry into force? Copyright 2015 BSI. All rights reserved. 5

6 Key Topics Scope and therefore the definitions The definition of an IVD will direct or indirect harm be included? Genetic tests Companion Diagnostics In-house exemptions what will the scope be, which classes of device and the extent of the Healthcare Institution Classification rules and associated conformity routes Clinical Evidence what are the expectations? device for genetic testing means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development; Companion diagnostic means a device specifically intended for and essential to the selection of patients with a previously diagnosed condition or predisposition as suitable or unsuitable for a specific therapy with a medicinal product or a range of medicinal products; Copyright 2015 BSI. All rights reserved. 6

8 Classification rules Draft IVDR rules have been based on the Global Harmonisation Task Force/GHTF rules (now found in IMDRF) Reference: Principles of IVD Medical Devices Classification SG1 Final Document GHTF/SG1/N045:2008 Already implemented by other IMDRF participating nations e.g. Australia and Canada (similar not identical) Copyright 2015 BSI. All rights reserved. 8

Classification rules Draft IVDR rules have been based on the Global Harmonisation Task Force/GHTF rules (now found in IMDRF) Reference: Principles of IVD Medical Devices Classification SG1 Final

9 Classification rules Draft IVDR rules have been based on the Global Harmonisation Task Force/GHTF rules (now found in IMDRF) Reference: Principles of IVD Medical Devices Classification SG1 Final Document GHTF/SG1/N045:2008 Already implemented by other IMDRF participating nations e.g. Australia and Canada (similar not identical) Rules are based on overall risk to Individual patient risk Population risk Copyright 2015 BSI. All rights reserved. 9

1.1. Application of the classification rules shall be governed by the intended purpose,

12 Work in progress Preparations to move from Annex II List A devices future Class D Common Technical Specification (CTS) Contain performance evaluation criteria Prepared by an Expert Group of the Commission Manufacturers expected to comply with the CTS if it exists Work in progress CTS in draft: HIV self-test CTS in progress Chagas disease Syphilis Copyright 2015 BSI. All rights reserved. 12

13 Under discussion Special Notified Bodies being viewed as a means of the European Commission and Regulators having greater scrutiny on NBs doing highest risk certifications Notified Body Class B & Class C Copyright 2015 BSI. All rights reserved. 13

IVD Regulation Require a Notified Body 80-90% Do not require a Notified Body

14 We are a growing team! IVD Directive Require a Notified Body Do not require a Notified Body 80-90% IVD Regulation Require a Notified Body 80-90% Do not require a Notified Body BSI IVD team Global span US, UK, Asia In-house expertise for all Annex II List A devices Copyright 2015 BSI. All rights reserved. 14

GHTF/SG5/N7:2012 - Clinical Evidence for IVD medical devices Scientific Validity Determination and Performance Evaluation.

16 Clinical Evidence under the proposed IVDR Increased expectation for clinical requirements Based on IMDRF (GHTF) guidance GHTF/SG5/N6:2012 Clinical Evidence for IVD medical devices Key Definitions and Concepts. GHTF/SG5/N7: Clinical Evidence for IVD medical devices Scientific Validity Determination and Performance Evaluation. GHTF/SG5/N8: Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices. Copyright 2015 BSI. All rights reserved. 16

Updates Development of a standard related to clinical performance studies for IVDs ISO TC 212 WG3 Clinical performance studies for in vitro diagnostic medical devices (IVDs) using specimens from

17 Updates Development of a standard related to clinical performance studies for IVDs ISO TC 212 WG3 Clinical performance studies for in vitro diagnostic medical devices (IVDs) using specimens from human subjects Good study practice. May be 5 years before publication New European requirements will be fully defined in an implementing act following IVDR publication Copyright 2015 BSI. All rights reserved. 17

Clinical Utility The usefulness of the results

population Clinical Utility has never been a

is still under discussion but likely to be

18 Clinical Utility The usefulness of the results obtained from testing with the IVD medical device and the value of the information to the individual being tested and/or the broader population Clinical Utility has never been a regulatory requirement in Europe Clinical Utility is still under discussion but likely to be required for Companion Diagnostics Copyright 2015 BSI. All rights reserved. 18

19 Three pillars of clinical evidence 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 Performance evaluation Data to support diagnostic accuracy compared to reference test; information related to expected values Copyright 2015 BSI. All rights reserved. 19

21 Impact! Planning for future clinical evidence requirements NOW! Future requirements need to be put into planning and development Transition period vital Existing IVD devices need to be reviewed There is no grandfathering Existing technical files / technical documentation may need to be supplemented This will be dependent on the device, intended use and risk Clinical evidence may be reviewed by a NB under the new classification rules Copyright 2015 BSI. All rights reserved. 21

Preparation! How would your devices be classified under the proposed rules? Plan for your products/ product families How could products be grouped under certificate scopes?

22 Preparation! How would your devices be classified under the proposed rules? Plan for your products/ product families How could products be grouped under certificate scopes? What conformity assessment routes would you take? Which first? Plan for technical file reviews Prioritise / sample QMS procedures Identify where new procedures will be needed or existing procedures may need to change Copyright 2015 BSI. All rights reserved. 22

Preparation! Talk to your Notified Body!

New BSI courses to help with the transition Performance Evaluation and clinical evidence for IVDs http://www.bsigroup.

24 New BSI courses to help with the transition Performance Evaluation and clinical evidence for IVDs Technical Files and Design Dossiers for IVDs US event: San Diego, 3, 4 & 5 March Preparing for the IVD Regulation Copyright 2015 BSI. All rights reserved. 24

Contacts Name: Sue Spencer Head of IVD Mobile: +44 (0)7785 716906 Email: sue.spencer@bsigroup.com Website: http://medicaldevices.

European IVD Regulations and Risk Based Classification. An Overview for Global Quality Professionals

European IVD Regulations and Risk Based Classification An Overview for Global Quality Professionals Anna Sadio IVD Technical Expert/Project Manager Oct 2013 Caution The new regulations are draft and subject