1. The concept for a network of national Reference Laboratories for high risk IVDs – Results of the working group meeting 1

2. Medical Devices Roadmap 11.10.2010 2 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 and uniformity of approach in particular due to the lack of efficient coordination between the Member 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.“

3. Concept for a network of national Reference Laboratories for high risk IVDs 27 th Meeting of the CAMD Budapest, 24-25. February, 2011 Presentation by M. Funk →Working Group for further Elaboration 3

4. Concept for a network of national Reference Laboratories for high risk IVDs Working Group Meeting Langen, 27. June, 2011 Participants: FR, UK, IR, DE DG Sanco, Joint Research Centre (JRC) IVD Technical Group Brussels, 15. September, 2011 Task Force Ref Lab Network: BE, FR, UK, DE; JRC → Concept Paper “Plan for a network...” 4

5. 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 5 Concept for a network of national Reference Laboratories for high risk IVDs

6. Conformity Assessment of High Risk Devices IVD-ManufacturerNotified Body QS Annex IV, 3 DE Annex IV, 4 BV Annex IV, 6 QS Quality System DE Design Examination BV Batch Verification 1234 6

7. 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 7 Concept for a network of national Reference Laboratories for high risk IVDs

8. 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 8 Concept for a network of national Reference Laboratories for high risk IVDs

9. IVD-ManufacturerNotified Body Reference Laboratory QS Annex IV, 3 DE Annex IV, 4 BV Annex IV, 6 QS Quality System DE Design Examination BV Batch Verification Experimental assessment of key performance aspects Pre-market assessment 9 Concept for a network of national Reference Laboratories for high risk IVDs

10. Experimental assessment of key performance aspects Sensitivity / specificity diagnostic sensitivity of serological blood screening assays analytical sensitivity of NAT blood screening assays viral 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 10 Concept for a network of national Reference Laboratories for high risk IVDs → Within RL Network: overview of “state of the art”

11. IVD-ManufacturerNotified Body Reference Laboratory QS Annex IV, 3 DE Annex IV, 4 BV Annex IV, 6 QS Quality System DE Design Examination BV Batch Verification Batch Verification 11 Concept for a network of national Reference Laboratories for high risk IVDs Pre-market assessment

12. 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 12 Concept for a network of national Reference Laboratories for high risk IVDs

13. Tasks of Reference Laboratories (RL) Network Post-Market 13 Concept for a network of national Reference Laboratories for high risk IVDs Reference Laboratories Network: source of expertise to advise the European Commission on CTS for new high-risk devices (GHTF, D?) on regular updating of the CTS on safeguard clauses on evolving technologies, emerging pathogens,... to support Competent Authorities in the estimation of incident reports by offering experimental studies by providing support for market surveillance by determining the „state of the art“

14. 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 14 Concept for a network of national Reference Laboratories for high risk IVDs

15. 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 15 Concept for a network of national Reference Laboratories for high risk IVDs

16. 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 System DE Design Examination BV Batch Verification 16

17. 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 17 Concept for a network of national Reference Laboratories for high risk IVDs

18. 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) ? 18 Concept for a network of national Reference Laboratories for high risk IVDs

19. 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 19 Concept for a network of national Reference Laboratories for high risk IVDs

20. Thank you for your attention ! 20