S.L. 427.16 Art. 6application or and to be carried out in view of its label and its conforms with an EC to be with the contain the needed for of the the EC design- design. notified body changes could or with the shall take the

For devices for self-testing the manufacturer shall lodge an examination of the medical design with a notified body. 6.1. The application shall enable the design of the device to be understood shall enable conformity with the design-related requirements of the regulations assessed. It shall include: - test reports including, where appropriate, results of studies with lay persons, - data showing the handling suitability of the device intended purpose for self-testing, - the information to be provided with the device on its instructions for use.

6.2. The notified body shall examine the application and, if the design to the relevant provisions of these regulations, shall issue the applicant design-examination certificate. The notified body may require the application completed by further tests or proof to allow assessment of conformity design-related requirements of the regulations. The certificate shall conclusions of the examination, the conditions of validity, the data identification of the approved design and, where appropriate, a description intended purpose of the product.

6.3. The applicant shall inform the notified body which issued examination certificate of any significant change made to the approved Changes to the approved design must receive further approval from the which issued the EC design-examination certificate wherever the affect conformity with the essential requirements of the regulations conditions prescribed for use of the product. This additional approval form of a supplement to the EC design-examination certificate.

SCHEDULE IV Based on Annex IV of the Directive

EC DECLARATION OF CONFORMITY (FULL QUALITY ASSURANCE SYSTEM)