What are the general technical requirements to bring my medical device product to the European market?
(18 June 2009)
B. DESIGN AND MANUFACTURING REQUIREMENTS
7. Requirements for devices for self-testing
Devices for self-testing must be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in users’ technique and environment. The information and instructions provided by the manufacturer should be easily understood and applied by the user.
7.1. Devices for self-testing must be designed and manufactured in such a way as to:
- ensure that the device is easy to use by the intended lay user at all stages of the procedure, and
- reduce as far as practicable the risk of user error in the handling of the device and in the interpretation of the results.
7.2. Devices for self-testing must, where reasonably possible, include user control, i.e. a procedure by which the user can verify that, at the time of use, the product will perform as intended.