Slovenia – Medical Device Registration Guideline
€ 189,00
Regulamedica Guidelines are provided in English language only, however per your request we should be able to translated to other language
Guidelines are continuously accessible online thru Regulamedica® user panel, also mobile compatible
Description
PURPOSE
The purpose of this document is to provide orientation to the industry professionals in regard to regulatory requirements concerning market authorization of medical devices in Slovenia. Furthermore, information provided might serve as starting point at investigating regulatory requirements for new product development planning. The information has been collected by reviewing the relevant laws and ordinances as well as in direct communication with officials of national bodies and trusted user’s experiences. The guideline has been also created for purpose of providing summary of regulatory information at single location in order to save time and effort of its users.
Regulamedica® is a consulting project for “unknown user” and does not act on behalf of any National Agency, therefore formal information concerning registration of medical device is only provided by relevant national authority sources of information.
SCOPE
The document provides regulatory information for registration of medical device (as defined by 93/42/EEC MDD) at Slovenian National Agency, in purpose of its placement to Slovenian market. The Guideline is applicable only to medical devices with CE marking.
OTHER
Guidelines are continuously accessible online thru Regulamedica® user panel, also mobile compatible
Table of Content
1.0 PURPOSE
2.0 SCOPE
3.0 RESPONSIBLE NATIONAL AUTHORITY
4.0 REGULATORY REQUIREMENTS
4.1 Medical device conformity
4.2 Medical device registration requirements
4.3 Applicant
5.0 REGISTRATION STEPS
6.0 DOCUMENTATION REQUIREMENTS AND ASSEMBLY
6.1 Registration documentation
6.2 Notification documentation
7.0 FORMS
8.0 INFORMATION REQUIRED BY APPLICATION FORMS
9.0 APPLICATION STATUS AND REVIEW TIMELINE
9.1 Registration
9.2 Notification
10.0 REJECTION
10.1 Registration rejection
10.2 Notification concerns
11.0 REPRESENTATIVE REQUIREMENT
12.0 CLINICAL DOCUMENTATION
13.0 LANGUAGE REQUIREMENTS
13.1 Language
13.2 Instructions for use
13.3 Labelling
14.0 REGISTRATION FEE
15.0 REGISTRATION MAINTENANCE FEE
16.0 OTHER OBLIGATIONS
17.0 VIGILANCE
18.0 DEFINITIONS
19.0 REFERENCES
Snapshot
Medical devices with CE marking enjoy free movement in Slovenia, therefor NO REGISTRATION nor notification is required!
Registration is obligatory ONLY for medical device manufacturers and representatives located in Slovenia.
For those manufacturers coming from outside the European Union, more information on European Authorized Representatives (EAR) and other obligations in Regulamedica Guidelines.
Source ref.: March 2016