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  1. #745048

    Díreofar ar bhealach iomchuí ar ghnéithe iomchuí teicniúla agus feidhmiúla na feiste, go háirithe na cinn a bhaineann le sábháilteacht agus le feidhmíocht, agus ar na torthaí cliniciúla a bhfuiltear ag súil leo astu i ndearadh an imscrúdaithe.

    All the appropriate technical and functional features of the device, in particular those involving safety and performance, and their expected clinical outcomes shall be appropriately addressed in the investigational design.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  2. #745152

    Achoimre ar an imscrúdú lena gcumhdaítear an teideal, cuspóir an imscrúdaithe, tuairisc ar an imscrúdú, dearadh an imscrúdaithe, na modhanna imscrúdaithe a úsáideadh, torthaí an imscrúdaithe agus an méid a baineadh de thátal as an imscrúdú.

    A summary of the investigation covering the title, purpose of the investigation, description of the investigation, investigational design and methods used, the results of the investigation and conclusion of the investigation.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )