Medical device registration — technical documentation and the procedure with the competent authority
We help medical device manufacturers, and the authorised representatives in Serbia of foreign manufacturers (usually wholesalers), register their devices in Serbia. Everyone on our team works in English, and we can prepare your documentation in English, Serbian or both; instructions for use for the Serbian market must also be available in Serbian.
Consulting on technical documentation
- The technical file for the medical device
- Risk management to SRPS EN ISO 14971:2020 (the Serbian adoption of ISO 14971:2019)
- The essential requirements for the medical device
- The list of harmonised standards
- Vigilance and post-market surveillance of medical devices
- Stability, biocompatibility and clinical evaluation of medical devices
Working with the authorities and conformity assessment bodies
- Preparation for certification to SRPS EN ISO 13485:2017, which is carried out by an accredited certification body
- Preparing the documentation for a manufacturing licence from the Ministry of Health of the Republic of Serbia, which is required for class I medical devices other than sterile devices (Is) and devices with a measuring function (Im), and for in vitro diagnostic devices in the ‘other’ category (not on List A or List B and not for self-testing)
- Support with conformity assessment by a Serbian designated body and the Serbian conformity mark, for higher-risk medical devices
- Support with CE marking, including conformity assessment by an EU notified body
- Registering the medical device with ALIMS (the Medicines and Medical Devices Agency of Serbia)
Consulting on outsourced activities
- Maintaining and monitoring the work environment
- Suppliers and customers
- Quality control
- Maintenance of production equipment and calibration of measuring equipment
- Handling production waste