1. Workshop on conformity assessment procedures and certification of medical devices INT MARKT 43755 Kyiv, 28-29 November 2011 In Vitro Diagnostic Directive 98/79 EC Jos Kraus Former Senior inspector Medical Technology Academic Medical Hospital; Amsterdam The Netherlands

2. Articles Definitions; article 1 Conformity assessment procedures; article 9 Annexes Essential requirements; Annex I “Classification”; Annex II Declaration of conformity; Annex III Quality system route; Annex IV Performance evaluation (~“clinical study”); Annex VIII Structure 2

3. ‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be......... Definitions 3

4. ......to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: Concerning a physiological or pathological state, or Concerning a congenital abnormality, or To determine the safety and compatibility with potential recipients, or To monitor therapeutic measures Definitions 2 4

5. Products for general laboratory use, IVD’s for forensic/military purpose, Products for research only Material used to collect or provide access to the specimen, BUT specimen collectors for primary containment are IVD’s (e.g. vacuum tubes) IVD (home brewed) is not subject to this Directive What is not an IVD 5

6. Definition of a medical device (old version) Classification rules are missing Annexes are not in the same ordering Annex II is “classification” versus Annex IX Annex III is similar to Annex II (quality system) Differences with 93/42 6

7. Essential requirements; Same principle of intrinsic safety, Risk based approach, Avoiding residual risk by design, Design is state of the art, Traceability to reference material of a higher order; a problem. Annex I: essential requirements 7

8. Chemical and physical properties, Infection and microbial contamination, Manufacturing and environmental properties, Devices with a measuring function, Protection against radiation, Devices connected to or equipped with an energy source, Requirements for devices for self-testing, Information supplied by the manufacturer, Annex I 8

9. List A Reagents and reagent products, including related calibrators and control materials for the determination the following blood groups: ABO system, rhesus (C,c,D,E,e) anti-kell, Reagents........ for the detection, conformation and qualification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV1 and II, and hepatitis B, C and D Annex II, High Risk 9

10. Determining of blood groups... Anti-erythrocytic antibodies, Congenital infections: rubella, toxoplasmosis, Phenylketonuria, Cytomegalovirus, Chlamydia, HLA tissue groups: DR, A, B, PSA, Trisomy 21, Self-diagnosis device …. blood sugar Annex II; Medium Risk; List B 10

11. Annex III point 6 (not applicable for List A and B) Test reports (including results of studies with lay persons; were appropriate) Self testing 11

12. Product identification data Evaluation plan List of laboratories Starting date and duration Location and number of persons involved (in case of device for self-testing) Statement about safety and performance All documents are available for CA’s and must be kept for 5 years after end of tests Annex VIII; Performance Evaluation 12

13. Notified by the Competent Authority Only for Annex II List A Batch release (!) List B And Self-diagnosis tests Most of the NBs work together with National institutes; like Paul Ehrlich, Pasteur and Sanguin. Notified Body 13

14. Annex II is limited in time CJD, SARS, N1H1 are all low risks IVD by definition State of the art is not defined Different HIV tests in the market with different sensitivity Home Brew IVD’s and ‘for research only’ The ‘back door’ of the system “Split testing” Limitations 14

15. Medical devices General Product Safety Directive (GPSD) Medicinal Products Personalised medicine Biocides Borderlines 15

16. IVD directive Different group of products Needs revision (is already on going) Definitions no longer in line with 93/42 New risks; not addressed properly Need of a timeless classification structure Same philosophy as the other medical devices Manufacturer is responsible Third party involvement Conclusion 16

17. I thank you for your attention