| Regulatory Authority | Office for Registration of Medicinal Products, Medical Devices and Biocidal |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Introduction of medical devices to the market and into use | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Device Classification Guidelines |
MDCG 2021-24: Guidance on classification of medical devices | Click Here |
| Registration Process | Notifications of Medical Devices | 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 |
| Technical Documentation Format |
The technical documentation for medical devices must adhere to the requirements set forth by the European Union's Medical Device Regulation |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Polish and / or English Language |
| Database | Database of medical devices | Click Here |
| Fees for Submission |
The amount of fees for medical devices, clinical trials of medical devices and performance studies is specified in the Regulation of the Minister of Health of 26 July 2022 on fees for medical devices | Click Here |
| Post Market Surveillance |
Manufacturers shall report any serious incidents immediately after establishing the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident. | Click Here |
| Reportable Incidents |
A serious incident means an incident that has directly or indirectly led to, could have led to or may lead to any of the following:
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| Adverse Event Reporting Form | Download |
| Additional Information | If the product labeling is in Polish, the instructions for use of the product are also in Polish or in the form of harmonized symbols or recognizable codes. If the labeling of the collective packaging is in Polish, the labeling of the unit packaging is also in Polish or in the form of harmonized symbols or recognizable codes. |