Joint Research Centre Health, Consumers & Reference Materials (Dir. F) Consumer Products Safety Unit (F.2)

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1 Joint Research Centre Health, Consumers & Reference Materials (Dir. F) Consumer Products Safety Unit (F.2) Arnd Hoeveler Birgit Sokull-Kluettgen Products Safety Nanomaterials Nanotechnology Medical Technology/ Devices

2 Medical Technology: increasing significance for modern health care plasters diagnostics... mobility aids implants robotic surgery Regulation on Medical Devices (MD) EU 2017/745 Regulation on in vitro diagnostic MD EU 2017/746 Strengthening the system: rules for putting Co-management devices on market of file by GROW, Tightening JRC, surveillance SANTE post-market Continuous follow-up of device quality, performance, safety JRC is focussing on specific scientific and technical areas Stronger rules for high-risk devices More transparency: information accessible to patients & general public Strengthening Member States cooperation Novel dedicated scientific structures: e.g. expert panels & EU reference laboratories

3 Nanotechnology for consumers and in healthcare Nanomaterials in food and consumer products Methods for the Implementation of the definition Methods for detection, characterisation and quantification Safety assessment of nanomaterials Harmonisation of test protocols and risk assessment methodologies Nanomedicine European Nanomedicine Characterisation Laboratory Quality assurance tools (Certified) Reference Materials (F.6, JRC-Geel) JRC Repository of Nanomaterials

4 State of the art laboratories 360 Virtual tour of Nano labs Open Access to JRC Infrastructure Nanobiotechnology Laboratory Opening to scientists and SMEs for R&D

5 What we offer? A wide range of facilities and cutting-edge instrumentation for interdisciplinary studies, with a special emphasis on characterisation of nanomaterials, nanomedicine and advanced materials Expertise in chemistry, physics, biology, material sciences, and nanobiosciences Training on state of the art instrumentation

6 Open access to the Nanotechnology Laboratory

7 Details of the call # RD-NanoBiotech Priority topics of the Nanobiotechnology laboratory Nanomaterial synthesis and characterisation Detection of nanomaterials in complex matrices Surface chemical analysis of nano- and macromaterials Characterisation of interaction of nanomaterials/ nanomedicines with biological systems (proteins, enzymes, cell membranes) Cell culture of adherent cells, cells in suspension (human & animal cell lines) In vitro assays for genotoxicity, immunotoxicity and cytotoxicity, uptake studies, transcriptomics Bio-interfaces characterisation, biocompatibility studies Surface modification and nano-fabrication Environmental and bio-sensors Advanced materials characterisation for applications beyond the biological-medical fields (energy, transport etc.)

8 Details of the call # RD-NanoBiotech Definition and conditions of access Access is granted on the basis of 'Access Units'. For the Nanobiotechnology Laboratory the Unit of Access is 'Instrument days' which correspond to the use of 1 instrument during 1 day. Estimated total number of Instrument days allocated to the call: Average number of Instrument days per project: 15 (i.e. 3 instruments for 5 days) Estimated costs excluding consumables and expenses: Research infrastructure operated by JRC staff: 126 / instrument day Research infrastructure operated by users: 55 / instrument day

9 How to apply Details of the call # RD-NanoBiotech Read the "Framework of Access to Joint Research Centre physical Research Infrastructures" and its Annexes. The proposal must be prepared by using the template given in Annex 3.1 Fill in the form "Requested facilities/instrumentation" Applicants are encouraged to contact the research infrastructure to assess feasibility aspects: The proposal should be submitted to by the closing date of the call Closure of the current Nanobiotechnology call: 13/04/2018

10 Thank you for your attention! Questions? Stay in touch!