Regulation (EU) 2017/745 of the European Parliament and of the CouncilDangos y teitl llawn

1. Application form

The application form shall be duly filled in, containing information regarding:

1.1.

name, address and contact details of the sponsor and, if applicable, name, address and contact details of its contact person or legal representative in accordance with Article 62(2) established in the Union;

1.2.

if different from those in Section 1.1, name, address and contact details of the manufacturer of the device intended for clinical investigation and, if applicable, of its authorised representative;

1.3.

title of the clinical investigation;

1.4.

status of the clinical investigation application (i.e. first submission, resubmission, significant amendment);

1.5.

details and/or reference to the clinical evaluation plan;

1.6.

If the application is a resubmission with regard to a device for which an application has been already submitted, the date or dates and reference number or numbers of the earlier application or in the case of significant amendment, reference to the original application. The sponsor shall identify all of the changes from the previous application together with a rationale for those changes, in particular, whether any changes have been made to address conclusions of previous competent authority or ethics committee reviews;

1.7.

if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;

1.8.

identification of the Member States and third countries in which the clinical investigation is to be conducted as part of a multicentre or multinational study at the time of application;

1.9.

a brief description of the investigational device, its classification and other information necessary for the identification of the device and device type;

1.10.

information as to whether the device incorporates a medicinal substance, including a human blood or plasma derivative or whether it is manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives;

1.11.

summary of the clinical investigation plan including the objective or objectives of the clinical investigation, the number and gender of subjects, criteria for subject selection, whether there are subjects under 18 years of age, design of the investigation such as controlled and/or randomised studies, planned dates of commencement and of completion of the clinical investigation;

1.12.

if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;

1.13.

evidence from the sponsor that the clinical investigator and the investigational site are capable of conducting the clinical investigation in accordance with the clinical investigation plan;

1.14.

details of the anticipated start date and duration of the investigation;

1.15.

details to identify the notified body, if already involved at the stage of application for a clinical investigation;

1.16.

confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is assessing or has assessed the application; and

1.17.

the statement referred to in Section 4.1.