The German Standardization Roadmap Mobile Diagnostic Systems. Thorsten Prinz and Janina Laurila-Dürsch Düsseldorf,

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1 The German Standardization Roadmap Mobile Diagnostic Systems Thorsten Prinz and Janina Laurila-Dürsch Düsseldorf,

2 Medical Engineering at VDE Do you standardize or are you standardized? The German Standardization Roadmap Mobile Diagnostic Systems 2014 VDE Association for Electrical, Electronic & Information Technologies 2

3 Facts VDE VDE Verband der Elektrotechnik Elektronik Informationstechnik e.v. English: VDE Association for Electrical, Electronic & Information Technologies Founded in 1893 on the initiative of Werner von Siemens and others 1906 one of the few founders of IEC Standardization Organization Headquarters in Frankfurt/Main, political representation in Berlin and Brussels Offices in Europe, Africa, Asia and North America personal members, students company memberships participants at VDE events every year Support of young engineers within 60 university groups employees 2014 VDE Association for Electrical, Electronic & Information Technologies 3

4 Medical Engineering at VDE German Society for Biomedical Engineering within VDE - Science - German Commission for Electrical, Electronic & Information Technologies of DIN and VDE - Standards - VDE Testing and Certification Institute - Testing VDE Association for Electrical, Electronic & Information Technologies 4

5 DKE in the national and international standardization Standardization General Electrical Technology Telecommunication Regulation International ISO IEC International Agreements Europe (regional) CEN CENELEC ETSI European Legislation Germany (national) DKE DKE German Legislation 2014 VDE Association for Electrical, Electronic & Information Technologies 5

6 Medical Engineering at VDE Do you standardize or are you standardized? The German Standardization Roadmap Mobile Diagnostic Systems 2014 VDE Association for Electrical, Electronic & Information Technologies 6

7 Benefits of the standardization Removal of trade barriers, global liberalization System compatibility, interoperability and interchangeability Basis for product testing: quality and safety Safety of electrical products and systems to protect people, animals and goods Acceleration in spreading of technical innovation, knowledge transfer Neutral industry platform Economic benefit of standards amounts to billion Euros a year Source: VDE Association for Electrical, Electronic & Information Technologies 7

8 Harmonized Standards and what else? Harmonized Standards Common Technical Specifications Article 6 1. Devices which are in conformity with the relevant harmonised standards, or parts thereof, [ ] shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. Article 7 1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, the Commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements [ ] 2014 VDE Association for Electrical, Electronic & Information Technologies 8

9 Usability nice to have or a legal requirement? EU Medical Device Directive, Annex I, Essential Requirements The devices must be designed and manufactured in such a way that, [ ] they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons [ ] This shall include: reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety) [ ] 2014 VDE Association for Electrical, Electronic & Information Technologies 9

10 Standards reduce risks Unintended USE ERROR See also Annex C Slip Examples Attentional failure Intrusion Omission Reversal Misordering Mistiming EN Application of usability engineering Action Intended Lapse Mistake CORRECT USE Memory failure Omitting planned item Place-losing Forgetting intentions Rule-based error Misapplication of good rule Application of bad rule Knowledge-based error Misapplication of good rule Nescient error Routine violation Well-meant optimization Shortcut Improvisation in unusual circumstances Following good practice ACCOMPANYING DOCUMENTS Professional knowledge Maintenance, training, calibration NORMAL USE Development based on usability Higher safety / less risks ABNORMAL USE Inadequately trained or unqualified use Exceptional violation Action that is contraindicated Reckless use Sabotage 2014 VDE Association for Electrical, Electronic & Information Technologies 10

11 Medical Engineering at VDE Do you standardize or are you standardized? The German Standardization Roadmap Mobile Diagnostic Systems 2014 VDE Association for Electrical, Electronic & Information Technologies 11

12 Participation in the Roadmap work and subsequent standardization activities Currently, 23 experts from industry, universities, institutes, clinics and other organizations! Participating experts acquire detailed regulatory knowledge, network with other experts, have an information advantage, may introduce their own perspectives, obtain information on technology trends and markets at an early stage and steer future activities VDE Association for Electrical, Electronic & Information Technologies 12

13 Scope and objectives of the Standardization Roadmap Focus on In-vitro Diagnostics (IVD) in the application field "Point-of-Care Testing" (POCT) Objectives: Analysis of technical and legal framework, Description of the status quo of existing standards and guidelines as well as Recommendations of experts for further standardization activities VDE Association for Electrical, Electronic & Information Technologies 13

14 Recommendations on normative amendments and further developments Definitions and terms Regulatory requirement during development Analytical method development/ validation Interoperability Reform EU legislation Training and competence Quality assurance test results Data security/ management/control Qualification of supplier s components Maintenance and servicing VDE Association for Electrical, Electronic & Information Technologies 14

15 Example of normative amendment: classification according to the new European regulation IVD classification List A of Annex II (high risk), List B in Annex II (risk), Products for self-testing and all other IVD Proposal EU-Regulation: Classes A, B, C and D (lowest risk to highest risk) normative document for the application of the new rules previous example: application guide VDE-AR-E "Approach to the classification of medical devices and the selection of conformity assessment procedure" VDE Association for Electrical, Electronic & Information Technologies 15

16 Recommendations on better involvement in the standardization especially of SME Funding participation in the standardization Annual forum for mobile diagnostics Support of regulatory matters in funding projects Assessment of needs by expert group VDE Association for Electrical, Electronic & Information Technologies 16

17 How can you participate (free of charge)? Contact us! Contribute as an expert to further developments of the Roadmap and/or take part in subsequent standardization activities! VDE Association for Electrical, Electronic & Information Technologies 17

18 Thank you for your attention! VDE Networking the Future Mobile Diagnostik am Point-of-Care 2015 Nutzen Anwendungen Technologien 17. Juni 2015 Düsseldorf Life Science Center Your contact: Dr. Thorsten Prinz German Society for Biomedical Engineering within VDE (DGBMT) Phone: Dipl.-Ing. Janina Laurila-Dürsch German Commission for Electrical, Electronic & Information Technologies of DIN and VDE Phone:

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