25.06.2025
To the attention of manufacturers of medical devices residing in Romania
We hereby inform you that the Romanian manufacturers, notifying medical devices to the NAMMDR for registration into the national database in accordance with Order of the Minister of Health no. 3.539/2022 on approval of the Methodological rules for placement on the market of medical devices and registration of economic operators into the European database on medical devices (EUDAMED), as well as into the national database, and on waiver from compliance assessment procedures or with Order of the Minister of Health no. 2.845 of 29 September 2022 on approval of the Methodological rules for approval of provisions of Article 13 of Emergency Government Ordinance no. 46/2021 on the establishment of the institutional framework and the measures necessary to ensure the direct application of the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) no. 178/2002 and Regulation (EC) no. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, on registration of custom-made devices placed on the market under their own name by manufacturers based in Romania, must submit in the documentation related to the request the registration certificate at the National Trade Register Office (ONRC) and a certificate attesting the authorisation of the manufacturing of the medical devices, by indicating the CAEN code (rev.3), specific to the type of the notified medical device.

Examples:

CAEN 3250, Manufacture of devices, devices and dental tools for:

• manufacture of surgical cloths and catgut,
• manufacture of distillate devices and laboratory centrifuges,
• manufacture of medical, surgical, dental furniture,
• manufacture of ophthalmic articles, eyeglasses, polished lenses according to the recipe, contact lenses,
• manufacture of disposable protective masks (surgical masks, FFP2, FFP3 masks, etc.)

CAEN 2120, Manufacturing of pharmaceutical preparations

• medical diagnosis preparations, including pregnancy tests,
• Radioactive tracers for in vivo clinical diagnosis,
• cotton wool, gauze, cloth, impregnated medicinal bandages, surgical catgut, etc.
• ultrasound medical equipment,
• electrocardiographs,
• endoscopic medical equipment

CAEN 2660, Manufacture of equipment for radiology, electrodiagnostic and electrotherapy

CAEN 6210, Activities related to set up of the software on command

Software set up – medical device