Investigação clínica em dispositivos médicos

1. Geertsma G E and col, New and Emerging Medical Technologies: A horizon scan of opportunities and risks, RIVM Report 66/07 BMT/ RB/RG/cvr , 2007.
2. Bekey G and col., WTEC Panel Report on: International Assessment of Research and development in Robotics, 2006
3. European Commission – DG Health & Consumer. Medical Devices: New & Emerging Technologies Working Group (NET) – Relatório
de 06.07.2011 do subgrupo SIG: Horizon Scanning – Robotics and Autonomous Systems. Não publicado
4. Roszek B and col, Nanotechnology in medical applictions – State-of-the-art in materials and devices, RIVM Report 266001001/2006,
2006.
6. European Commission – DG Health & Consumer. Medical Devices: New & Emerging Technologies Working Group (NET) – Relatório
de 22.08.2006 de Nanotechnology in medical applictions – State-of-the-art. Não publicado
6. Diretiva no 90/386/CEE do Conselho, de 20 de junho e Diretiva no 93/42/CEE do Conselho, de 14 de junho .
7. Diretiva no 98/79/CE, do Parlamento Europeu e do Conselho de 27 de outubro
8. European Commission – DG Health & Consumers – Medical devices: MEDDEV 2.7.1 rev3. Clinical Evaluation: A Guide for manufactu-
rers and Notified Bodies. http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf
9. Decreto-Lei no 146/2009. Diário da República. I Série: 116 (17.06.2009) 3707-3766.
10. European Commission – DG Health & Consumers – Medical devices: MEDDEV 2.7/4. A guide for manufacturers and notified Bodies.
http://ec.europa.eu/health/medical-devices/files/meddev/2_7_4_en.pdf.
11. EN ISO 14166:2011 “Clinical investigation of medical devices for human subjects – Good clinical practice” publicada no Jornal Oficial da
União Europeia (OJ C123 de 27 abril de 2012).
12. European Commission – DG Health & Consumers – Medical devices: MEDDEV 2.12.2 rev2. Post Market Clinical Follow-up Studies – A
Guide for Manufacturers and Notified Bodies.
http://ec.europa.eu/health/medical-devices/files/meddev/2_12_2_ol_en.pdf
13. Mais informação poderá ser consultada no site do Infarmed, em: http://www.infarmed.pt.
14. COM(2012) 642 final, 26.09.2012 – Proposal for a Regulation of the European Parliament and the Council on medical devices. Acedido
em: http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_642_en.pdf
16. Neves M J, Mota Filipe H, (In)Sucesso da marcação CE nos dispositivos médicos. Análise SWOT e propostas de melhoria. Rev. Port. Far-
macoter. 2012; 4:276-296
16. COM(2012) 640 final, 26.09.2012 – Communication from the Commission – Safe, effective and innovative devices and in vitro diagnostic
medical devices for the benefit of patients, consumers and healthcare professionals. Acedido em:http://ec.europa.eu/health/medical-devices/ files/revision_docs/com_2012_640_revision_en.pdf