Српски
search
site map
e-mail
print
contacts
Forms – Medical devices
Guideline for obtaining the marketing authorization for a medical device
| Guideline for form filling |  |
 |
| A. A Guideline for the preparation of documentation for obtaining the marketing authorization for a medical device with the CE marking | |
|
| B. A Guideline for the preparation of documentation for obtaining the marketing authorization for a medical device which has the marketing authorization granted on the basis of provisions in force until the effective date of the Law on Medicinal Products and Medical Devices, and which has the CE marking (according to Article 159. of the Law in force) | |
|
| C. A Guideline for the preparation of documentation for obtaining the marketing authorization for a medical device which is not in compliance with regulations of EU directives for medical devices, i.e. which does not have the CE marking | |
|
Forms regarding the obtaining the marketing authorization for a medical device
IMPORTANT !
Along forms 1, 2 and 3, it is obligatory to fill in Attachment 1, as well as the form given in Item 5.
| 1. Application for obtaining authorization, variation, amendation and renewal of a medical device class I | |
|
| 2. Application for obtaining authorization, variation, amendation and renewal of a medical device class IIа, IIb and III | |
|
| 3. Application for obtaining authorization, variation, amendation and renewal of In Vitro diagnostic medical devices | |
|
| 4. Application for obtaining authorization, variation, amendation and renewal of AIMD medical devices | |
|
| 5. Responsibility for the product | |
|
| 6. Application of a clinical trial of a medical device | |
|
| Attachment 1 |  |