Medical Devices
Medical Device Directive 93/42/EEC
The new regulation MDR replaced the Medical Device Directive (93/42/EEC) on 26 May 2021. As of this date, certificates under the MDD can no longer be issued. From 26 May 2024, the requirements of the new MDR must be complied with by all medical devices regardless of their risk class. In 2023, Regulation (EU) 2023/607 was issued, extending the validity of certificates issued in accordance with the MDD Directive, and extending the transitional period during which devices, compliant with the mentioned directive, can be placed on the market.
Maintenance of certificates for medical devices under Directive 93/42/EEC
The certification procedure under the MDD 93/42/EEC directive is no longer possible from 26 May 2021, when the directive was replaced by the Regulation MDR (EU) 2017/745. Notified bodies for medical devices only carry out procedures for maintaining certificates under MDD 93/42/EEC, issued before 26 May 2021.
Links
Medical Devices Act (Official Gazette of the Republic of Slovenia)
Rules on medical devices (Official Gazette of the Republic of Slovenia)
European Guidance to Assist Stakeholders in Implementing Directives Related to Medical Devices
Certification of Medical Devices
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Notice of change in the product or in the management system
Fees according to Regulation MDR (EU) 2017/745, MDD 93/42/EEC on medical devices and ISO 13485:2016