QFI Website Form for Reporting EC Classification Problems

Please submit the following information to report your experiences with EC classification problems.

Note: fields marked with an asterisk (*) are mandatory

1.	Please indicate the type of medical device (e.g. vascular stent, pacemaker, syringe) and be as specific as possible*:
2.	Is the device active?* Yes No
3.	Please specify the device's intended purpose*:
4.	Please specify the device's mode of action*:
5.	Please indicate the duration of contact with the body (specify minutes and hours)*:
6.	Please specify the classification rule applied*: Class I Class IIa Class IIb Class III Please specify the regulations applied (e.g. Directives, standards):
7.	Please specify the nature of the disagreement expressed by a Competent Authority or Notified Body*:
8.	Please specify how the issue was resolved (if applicable):
9.	Please specify the CE Marking status*:
10.	Please specify the Competent Authority concerned (i.e. the EU Member State)*:
11.	Please specify the Member State of the Notified Body concerned*:
12.	Company name:
13.	Contact person:
14.	Contact details (telephone, email):
15.	Product's brand name: