Slovenia has recently adopted the new Medical Devices Act (Zakon o medicinskih pripomočkih – ZMedPri-1), aligning national legislation with the EU Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR). The Act, adopted on 23 May 2025, introduces a harmonized and structured regulatory framework governing the placing on the market, availability, and use of medical devices and in vitro diagnostic medical devices.
One of the key novelties of the Act is the reinforcement of medical device technical file. Manufacturers are now explicitly required to maintain a medical device technical file (formerly referred to as a technical file), demonstrating compliance with General Safety and Performance Requirements (Annex I of MDR/IVDR). This file must include up-to-date information on product design and manufacturing, risk management documentation, clinical evaluation (or performance evaluation for IVDs), and a post-market surveillance (PMS) plan. The medical device technical file must be readily available for review by the competent authority (JAZMP) or notified body, as applicable.
The Act further clarifies and strengthens the obligations of economic operators (manufacturers, authorized representatives, importers, and distributors), including:
- ensuring traceability and compliance with Unique Device Identification (UDI) and EUDAMED registration,
- maintaining documented quality management systems (QMS),
- ensuring appropriate market surveillance and vigilance reporting,
- and implementing defined roles for Persons Responsible for Regulatory Compliance (PRRC).
In addition, ZMedPri-1 empowers JAZMP to engage external experts, outlines enhanced obligations and oversight of notified bodies, and introduces a system of proportionate penalties for regulatory non-compliance.
At Billev Pharma East, we recognize the complexities introduced by the new legislation and the EU regulatory framework. If your organization requires expert support in compiling or updating medical device technical file, ensuring compliance with MDR/IVDR, or assistance with internal audits, regulatory strategy, vigilance, or PMS system implementation, our experienced team is here to help.
Read also:
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- Medical Device Technical File Requirements for CE Marking
Source: 1 – Government of the Republic of Slovenia (2025, May 23). Sprejeta zakona o poklicnih kvalifikacijah in medicinskih pripomočkih.
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