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The concept for a network of national Reference Laboratories for high risk IVDs

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Results of the working group meeting

Medical Devices Roadmap11.10.2010

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Elements which may be considered.....

....“Ensuring uniform high standards and criteria for the conformity assessment by notified bodies, in particular as regards the assessment of the manufacturer's clinical evaluation and in the field of new technologies“

....“Alignment of the classification of IVDs with GHTF guidance”

Main problems identified....

.....“The key elements to the framework are Market Surveillance, Vigilance, Notified Bodies,Clinical Evaluation and Transparency. These areas have suffered in terms of coherence anduniformity of approach in particular due to the lack of efficient coordination between theMember States.“

.....“New and emerging technologies have challenged the current framework, highlighting gaps or pointing to potential loopholes including the scarcity of expertise needed to independently assess such technologies. The framework needs to fill these gaps and be made more robust to future technologies.“

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Concept for a network of national Reference Laboratories for high risk IVDs

27th Meeting of the CAMD Budapest, 24-25. February, 2011Presentation by M. Funk

→ Working Group for further Elaboration

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Concept for a network of national Reference Laboratories for high risk IVDs

Working Group MeetingLangen, 27. June, 2011

Participants: FR, UK, IR, DEDG Sanco, Joint Research Centre (JRC)

IVD Technical GroupBrussels, 15. September, 2011Task Force Ref Lab Network: BE, FR, UK, DE; JRC

→ Concept Paper “Plan for a network...”

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• Current situation

Manufacturers and Notified Bodies estimate...

...Risk – benefit ratio

...Compliance with „state of the art“

Fulfillment of CTS as indication of „state of the art“,

but...

...Most NBs need external expertise

...GHTF class D may include IVDs without CTS

Concept for a network of national Reference Laboratories for high risk IVDs

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Conformity Assessment of High Risk Devices

IVD-Manufacturer Notified BodyQS Annex IV, 3

DE Annex IV, 4

BV Annex IV, 6

QS Quality SystemDE Design Examination BV Batch Verification

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• Network of Reference Laboratories

– Uniform determination of „state of the art“

– Boost the trust of users and patients

– Benefit for IVD industry

– Good experience with EU Reference Laboratories in the food sector

Concept for a network of national Reference Laboratories for high risk IVDs

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• Tasks of Reference Laboratories (RL) Network

Pre-Market

– NB uses a RL within the Network for high risk devices (GHTF D)

• Experimental Pre-market assessment of key aspects

• Batch verification

Concept for a network of national Reference Laboratories for high risk IVDs

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IVD-Manufacturer Notified Body

Reference Laboratory

QS Annex IV, 3

DE Annex IV, 4

BV Annex IV, 6

QS Quality SystemDE Design Examination BV Batch Verification

Experimental assessment of key performance aspects

Pre-market assessment

Concept for a network of national Reference Laboratories for high risk IVDs

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Experimental assessment of key performance aspects

• Sensitivity / specificity

diagnostic sensitivity of serological blood screening assaysanalytical sensitivity of NAT blood screening assaysviral genotype inclusivity(accuracy of genetic tests, GHTF D?)

• Same pre-agreed specimens / panels within the Network

• Common data basis for CE-marked devices: „state of the art“

RL issues report on experimental assessment to NB

Concept for a network of national Reference Laboratories for high risk IVDs

→ Within RL Network: overview of “state of the art”

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IVD-Manufacturer Notified Body

Reference Laboratory

QS Annex IV, 3

DE Annex IV, 4

BV Annex IV, 6

QS Quality SystemDE Design Examination BV Batch Verification

Batch Verification

Concept for a network of national Reference Laboratories for high risk IVDs

Pre-market assessment

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Batch verification

The aim is an EU-uniform procedure

RL performs verification of new batches according to uniform pre-agreed criteria

frequency of verification testing

extent and focus of verification testing

common verification criteria

modalities of verification testing

RL issues batch verification test report to NB

Concept for a network of national Reference Laboratories for high risk IVDs

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• Tasks of Reference Laboratories (RL) Network

Post-Market

Concept for a network of national Reference Laboratories for high risk IVDs

Reference Laboratories Network: source of expertise

to advise the European Commissionon CTS for new high-risk devices (GHTF, D?)on regular updating of the CTS on safeguard clauseson evolving technologies, emerging pathogens, ...

to support Competent Authoritiesin the estimation of incident reportsby offering experimental studiesby providing support for market surveillance by determining the „state of the art“

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• Requirements for national Reference Laboratory

– Proven expertise

• assessment of GHTF class D devices• testing or calibration laboratory• developing reference materials• participating in external quality assessment schemes (EQAS) • scientific publications

– Sufficient ressources

– Certified QM system (e.g. ISO EN 17025; 98/79/EC)

– International cooperation, information exchange

Concept for a network of national Reference Laboratories for high risk IVDs

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• Requirements for the Reference Laboratories Network

– Applying coordinated methods, procedures and processes

– Using the same reference materials and applying common evaluation methods

– Establishment of common assessment criteria

– Close cooperation within the network (joints guidelines, SOPs, harmonised approach within the network)

– Coordinating Body

Concept for a network of national Reference Laboratories for high risk IVDs

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Conformity Assessment of High Risk Devices

IVD-Manufacturer

Reference Laboratories Network

Notified Body

Coordinating Body

QS Annex IV, 3

DE Annex IV, 4

BV Annex IV, 6

QS Quality SystemDE Design Examination BV Batch Verification

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• Legal basis

• Reference Laboratories Network should be legally enshrined within the Directive

• Coordinating body should be defined by the Directive

• Defined minimum criteria (Directive / Committee / implementing acts)

• Competent Authority of the Member State: recognition and supervision of national Reference Laboratory

Concept for a network of national Reference Laboratories for high risk IVDs

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• Financial aspects

• Additional costs should be within manageable range

• External expertise already now used by NBs for assessment and batch verification

• Integration of the reference laboratory network into existing frame (DG Joint Research Centre of the European Commission) ?

Concept for a network of national Reference Laboratories for high risk IVDs

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Concept of IVD Reference Laboratories....

.... addresses deficiencies of current IVD system identified in the Road Map

.... provides specialised IVD expertise to cope with IVD challenges

.... enables assessment of evolving new technologies by experts

.... counteracts decreasing governmental IVD expertise

Concept for a network of national Reference Laboratories for high risk IVDs

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Thank you for your attention !