Regulation of CDx under the new In Vitro Diagnostics Regulation

Transcription

1 TOPRA Annual Medical Devices Symposium 2017 Regulation of CDx under the new In Vitro Diagnostics Regulation Challenges for Industry Peter Martin ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

2 Agenda: Regulation of CDx under the IVDR Authority Interactions during Conformity Assessment Transition for existing CDx

3 CDx definition CDx is defined in EU law for the first time IVDR Art. 2 (6) A device which is essential for the safe and effective use of a corresponding medicinal product to: identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or identify, before and/or during treatment, patients likely to be at increased risk for serious adverse reactions as a result of treatment with the corresponding medicinal product 3

4 CDx classification CDx are classified as class C or D! CDx are in risk class C (second highest risk) or D (highest risk) CDx are explicitly mentioned in Rule 3 as being in risk class C When would a CDx fall in risk class D? If it is used to determine the infectious load of a life-threatening disease where its monitoring is critical in the process of patient management 4

5 Instructions for use and device description How the drug shall be named in these documents The instructions for use for a CDx shall contain the INN (International Non-proprietary Name) of the associated medicinal product for which it is a companion test The device description for a CDx shall state, among others, the relevant target population and the associated medicinal product(s) This indicates that it is not possible to link the test to a specific branded drug 5

6 Instructions for use and device description Instructions for use shall include a link to public information For CDx intended to be used to assess the patient eligibility to a treatment with a specific medicinal product the instructions for use shall contain a link to the website where the summary of safety and performance is made available to the public via Eudamed This requirement to link to the publicly available information applies to commercialized tests 6

7 Clinical evidence Clinical evidence in practice The manufacturer must carry out systematic literature reviews including gap analysis, to appraise the data and as needed generate new data There is an obligation to carry out clinical performance studies unless it is duly justified to rely on other sources - interpretation space being explored Studies with CDx belong to the category special studies which are subject to strict requirements including prior approval by authorities, ethics review etc. Exception: Use of left-over samples only, in which case the study shall be subject to notification with the competent authority (& data protection law) 7

8 What will be public? Summary of safety and performance for class C and D IVDs What content? Summary of safety and performance for class C and D IVDs (including CDx) Formalia Should be written to be well understood by the public Publication Prepared by the manufacturer and uploaded by the Notified Body on Eudamed Label or instructions for use must state where the summary report is available 8

9 Agenda: Regulation of CDx under the IVDR Authority Interactions during Conformity Assessment Transition for existing CDx

10 Regulatory pathway CDx Regulatory pathway CDx Choice between the same basic pathways as for any class C or D IVD: QMS route Type examination route With the addition of an assessment by a drug regulator National or European Medicine s Agency (EMA) Depending on which agency approved the corresponding medicinal product The notified body may consult an expert panel For novel class D IVDs For class D IVDs where no CS exists 10

11 Conformity Assessment Pathway CDx (Class C) QMS + TDA of each CDx CDx Class C device CA by notified body OR Consultation of EMA or NCA by notified body EU market TE + PQA by notified body CA: Conformity Assessment CDx: Companion Diagnostics QMS: Quality Management System TDA: Technical Documentation Assessment PQA: Production Quality Assurance NCA: National Competent Authority TE: Type Examination 11

12 Regulatory pathway CDx Tasks for EMA QMS route The NB shall consult EMA or a national drug authority regarding the suitability of the device in relation to the medicinal product concerned. The NB shall give due consideration to the opinion [ ] when making its decision Type-examination route The NB shall seek the opinion, on the basis of the draft summary of safety and performance and the draft instructions for use of EMA or the national drug authority, on the suitability of the device in relation to the medicinal product concerned If the manufacturer informs the NB of any changes affecting the performance or the intended use, or its suitability to a medicinal product, the NB of the CDx shall again consult EMA or the national drug authority 12

13 Regulatory pathway CDx Notified Bodies and the Commission to further specify procedures The NB shall establish quality criteria for companion diagnostics (if such products fall within the scope of their designation) The NB is obliged, in the case of CDx, to have documented procedures in place for consultation of the EMA and national drug authority The Commission is empowered to adopt Implementing Acts on procedural aspects of the Conformity Assessment Procedures 13

14 Agenda: Regulation of CDx under the IVDR Authority Interactions during Conformity Assessment Transition for existing CDx

15 Transition for existing CDx What is covered by the text of the IVDR? Co-development and co-review together with Companion drug Development of a follow on CDx for an existing Drug 15

16 Transition for existing CDx Existing CDx portfolio Three categories of IVDD are currently used for CDx purposes Co-developed CDx products Follow on CDx products CE IVD that are referenced in a drug label Necessary for safe and effective use of drugs that are on the EU market CE marked under Annex III of the IVDD No NB or EMA review was necessary to bring those CDx to the market Retrospective review of such CDx by NB and EMA will be necessary 16

17 Transition for existing CDx Situation of retrospective review of data of existing CDx CE marked under Annex III of the IVDD No NB or EMA review was necessary to bring those CDx to the market Retrospective review of such CDx by NB and EMA will be necessary Access of authority to data concerning the companion drug What happens in case EMA finds data insufficient? o o o Access to samples can not be guaranteed for additional data Already marketed drug is dependent on CDx Ethical concerns on collecting new samples may exist 17

18 Conclusion CDx regulated under Class C* NB and EMA involvement for Conformity Assessment More data made available to the public compared to the past Pathway for transitioning existing CDx that are available in the market into the IVDR has some questions marks *Classification as Class D would apply only if a CDx is used to determine the infectious load of a life-threatening disease where its monitoring is critical in the process of patient management 18

19 Thanks a lot for your attention! 19

20 ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION