Governed by the European Union Medical Device and IVD Regulations (EU 2017/745, 2017/746)
| Regulatory Authority | State Institute for Drug Control |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Medical Devices Legislations | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Device Classification Guidelines | Medical device classification rules is based on Annex VIII; Chapter III of EUMDR 2017/745 |
| Registration Process | Documents to the State Institute | Click Here |
| Registration Timeline | For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Conformity Assessment Route |
The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such devices. For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory |
| Technical Documentation Format |
Annex II: technical documentation format 1. Device Description And Specification, Including Variants And Accessories 2. Information To Be Supplied By The Manufacturer 3. Design And Manufacturing Information 4. General Safety And Performance Requirements 5. Benefit-Risk Analysis And Risk Management 6. Product Verification And Validation
Annex III: Technical documentation on post-market surveillance |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Slovak Language |
| Labeling Requirements |
The instructions for use in the Slovak language must contain, as necessary, data in accordance with Annex No. 1, Chapter III, Section 23.4 to MDR No. 2017/745, or, as necessary, data in accordance with Annex No. 1, Point 13.6 of Government Decree No. 166/2020 Coll., with Annex No. 1, Point 2.10 and Point 2.11 of Government Decree No. 167/2020 for medical devices placed on the market before 26.5.2021. | Click Here |
| Clinical Trials Information |
The main activities of the Clinical Trials Department include: • assessing applications for grant of permission of clinical trials on medicinal products • issuing permits for clinical trials of medicines • state supervision over the conduct of clinical trials • preparation of functional specifications for the forthcoming EU portal and database of the EU in cooperation with the European Medicines Agency, Member States and the European Commission | Click Here |
| Software Guidance Document |
MDCG 2023-4: Medical Device Software | Click Here |
| Database | Medical Device Databse | Click Here |
| Declaration of Conformity |
A copy of the document is submitted in 1 copy, in the case of a foreign manufacturer either in English or in a multilingual version also with English, or if it is in a language other than English, with a translation into Slovak. | Click Here |
| Certificate of Free Sale |
Those interested in issuing a Free Sale Certificate shall follow the instructions published in the methodological guideline MP 148 Procedure for submitting an application for issuing a Free Sale Certificate. | Click Here |
| Post Market Surveillance |
Health Care Vigilance System | Click Here |
| Additional Information | For actions that a person (entity) intends to perform in _ |
| Contact Phone | 00421/2/50 70 11 11 |