The New EU IVD Regulation 2017/746: opportunities & threats for in-vitro diagnostics

Prof. Dr. C.M. CobbaertChair EFLM Task Force on European Regulatory AffairsEC observer to MDCG IVD groupApril 22, 2021

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European Federation for Clinical Chemistry and Laboratory Medicine

Diagnostic medicine´s contribution to Health Care

Clinical Chemistry & Laboratory Medicine

Microbiology

Virology

Human Genetics

Histopathology/molecular Pathology

Imaging

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Creation of added value through “SCIENCE”IN AN ACCREDITED LAB SETTING

S

C

I

E

N

E

C Raison d’ être

Standardisation/Harmonisation

ClinicalEffectiveness

Innovation

Evidence-basedPractice

Education of Others

CostEffectiveness

NovelApplications

Professional responsibilities of laboratory specialists

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Adding value to laboratory medicine: a professional responsibility. Beastall GH. CCLM, 2013, 51:221-7.

Role of Laboratory Medicine

Goal: improving patient management & patient outcome Tools: medical tests (CE-marked and in-house developed tests)Mechanism: supporting medical decisions

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I. Scope enlargement & (Re)Classification

II. Clinical Evidence Requirements

III. Notified bodies and Conformity Assessment for 85% of commercial tests (classes B and C);

IV. “In house” developed tests

Readiness of medical lab sector is for commercial tests fully dependent on timely test certification through EU Regulatory System, as intended in the IVDR (notified bodies, expert panels, reference labs, guidance documents, ….).

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Conformity Assessment Process of Commercial Tests

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Source: European Commission Survey on IVDR preparedness coordinated by MedtechEurope; survey results from 27 Jan-16 Febr 2021. By courtesy of Medtech Europe.

22 NBs 4 NBs

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85-90% of routine medical tests (class B & C) are affected by the HARD STOP date of May 25, 2022

Auto Immunity

Endocrinology

Clinical Chemistry

Metabolic diagnostics

Infectious disease

Microbiological culture

Allergy diagnostics

Oncology

Therapeutic Drug

Monitoring

IVDR timelines: implications for CE-marked tests?

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With courtesy to Volker Franzen

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P. Vermeersch et al., CCLM, 2020

922 different medical tests • 42% commercially available• 47% in-house developed test (LDT)• 11% other tests

Call for action on degrees of freedom laboratories need to use in house tests

to improve patient care

IVDR impact FOR IN HOUSE TESTS: UZ Leuven case study

For 72% of 537 in house developed/ other tests there is no alternative on the market.

Compliance with IVDR will require a huge investment of time and effort, without directly enhancing the benefit of patient care.

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Downstream Risks for Patients

Threats/exceed opportunities

Commercial testsfrom IVD-industry

In-house developed testsfrom academia

Concerns aboutcontinuity/availability of extensivelyused tests

X X

Concerns about increasing costswithout ROI

X X

Nullify innovations, niche tests, tests for rare diseases, …, harmingpatients

X X

Precision Diagnostics endangered X

Flexibility hampered – essentialduring pandemics

X

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Medical Laboratories perspective: ready for IVDR implementation per May 2022?

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Painting from Margaret Mulder

Reflections on “READINESS” for IVDR implementation per May 2022

IVD Regulation is intended to improve patient safety and test effectiveness ….

• Multiple essential CE-marked tests may not be available per DoA.

• Some specialty tests may also be unavailable (for genetics, virology, moleculardiagnostics..).

• This will cause serious harm to patients.

• A transparent contingency plan or a moratorium is ESSENTIAL.

• The IVDR should allow rapid innovation and EU-wide flexibility for derogationsand during pandemics.

• First COVID-19 tests available within weeks were in-house developed tests.

• Urgent ACTIONS are NOW needed to prevent UNACCEPTABLE CLINICAL RISKS.

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AcknowledgementsProf. M. Neumaier

& members of EFLM Task Force ERA

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https://www.eflm.eu/site/page/a/1650