Update on Recast of IVD Directive www.pei.de IVD Classification In-house Assays EU Reference Laboratories C M Nübling, PEI
Concerns identified by the European Commission in the Medical Devices Roadmap (11.10.2010)... 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.
Considerations of the European Commmission in the Medical Devices Roadmap (11.10.2010)... 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
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices proposal published September 2012 Regulation is direct European Law will replace IVD Directive 98/79/EC proposal out for comments different Working Groups (CoE, EP) define details and introduce further modifications
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices Notified Bodies Identification, traceability of devices Clinical evidence Vigilance, Market Surveillance IVD Classification In-house Assays EU Reference Laboratories
IVD Classification Class Health Risk Examples individual public A low low B moderate low C high moderate D high high Clinical chemistry analyser, selective culture media Vitamin B12, pregnancy self testing, anti-nuclear antibody, urine test strips Blood glucose self testing, HLA typing, PSA, Rubella, HIV VL, companion IVDs HIV blood donor screening, HIV diagn., ABO, Rhesus
Regulatory Requirements high IVD Classification Notified Body Reference Laboratory Batch Verification Notified Body QM System low IVD Class A B C D
Annex VII, Classification Criteria risk based classification rules higher flexibility with unforeseen markers past experience with inclusion of vcjd tests into Annex II List A global harmonisation
Products of Class D Article 4: in-house developed assays of class D markers are excluded from in-house privilege In different countries, modified (e.g. extraction) NAT systems or quantitave NATs have been successfully validated for blood screening Not all class D markers are covered by CE-marked assays (e.g. HIV-2 screening or diagnostic NATs) Rule 1: Screening, confirmatory and supplemental assays used for blood-, tissue- and organ-transmissible agents In practice, quantitative NAT assays for class D markers (e.g. HIV-1 NAT) often used for screening and/or confirmation of an infection
Reference Laboratories for Class D devices Article 78, Tasks Verify CTS compliance Tests on manufactured samples (batch testing) Scientific and technical advice European Commission Member States Notified Bodies Advice regarding state of the art
Reference Laboratories Article 78, Tasks Network of Reference Laboratories Development of testing methods for conformity assessment procedures and market surveillance Collaboration with Notified Bodies Recommendations on reference materials and reference measurement procedures Development of standards at international level Scientific opinions to Notified Bodies
Article 78, Tasks of Reference Laboratories (2e)...set up and manage a network of national Reference Laboratories...
Conclusions (1) Proposed Regulation on IVDs is an important improvement compared to the Directive 98/79/EC Classification Rules appear more flexible than Annex II Lists A, B of Directive 98/79/EC Rules do not always represent real practice of IVD use In-house exemption should be made possible for class D markers, too
Conclusions (2) Reference Laboratories following uniform evaluation and assessment schemes may be an important tool to guarantee IVD quality Tasks and modalities of batch testing need further clarification Structure of Reference Laboratory Network Concept of re-evaluations should be included Commission proposal has been published Modifications proposed by various stakeholders under discussion