whereas from Mary Shelley's Frankenstein's Monster to the classical myth of Pygmalion, through the story of Prague's Golem to the robot of Karel Čapek, who coined the word, people have fantasised about the possibility of building intelligent machines, more often than not androids with human features ī. – having regard to the report of the Committee on Legal Affairs and the opinions of the Committee on Transport and Tourism, the Committee on Civil Liberties, Justice and Home Affairs, the Committee on Employment and Social Affairs, the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection ( A8-0005/2017),Ī. – having regard to Rules 46 and 52 of its Rules of Procedure, – having regard to the study on Ethical Aspects of Cyber-Physical Systems carried out on behalf of the Parliament's Science and Technology Options Assessment (STOA) Panel and managed by the Scientific Foresight Unit (STOA), European Parliamentary Research Service – having regard to Council Directive 85/374/EEC (1), – having regard to Article 225 of the Treaty on the Functioning of the European Union, The TGA is expected to publish guidance on the transition to new manufacturer evidence for IVD medical devices soon.European Parliament resolution of 16 February 2017 with recommendations to the Commission on Civil Law Rules on Robotics ( 2015/2103(INL)) Sponsors will then need another form of acceptable manufacturer evidence to support their approved device. This means TGA can no longer accept ISO 13485 certificates to support IVD inclusion applications.Īpproved IVD medical devices supported by ISO 13485 certificates remain valid until the certificate expires. The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices has now ended as of. ISO 13485:2016 certificates issued by a body that is an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) ( for IVD inclusion applications until ).ISO 13485:2016 certificates issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC ( for IVD inclusion applications until ).Certificates and reports issued under the Medical Device Single Audit Program (MDSAP)*.Registrations of the Singapore Health Sciences Authority (HSA).Pre-market approvals from Japan (issued by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body (RCB), which is applicable).
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