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Medical devices

Medical devices

Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices

Medical Devices categories

Application for the registration of manufacturers and In Vitro Diagnostic Medical Devices placed on the market and/or putting into service in Bulgaria, in accordance with Art.28(1) and (3) of MDL / IVDMD Directive, Art.10

Application for the registration of manufacturers and medical devices, placed on the Bulgarian market and/or putting into service, in accordance with art. 27 (1) of MDL

Form to submit an information for medical devices putting into service in Bulgaria, in accordance with art. 30 of MDL

Form for the notification of In Vitro Diagnostic Medical Devices IVDMD Directive, Art.10.6

Medical devices

Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices

Template of Declaration of conformity contents (There are no translations available)

Important links about medical device regulation:

  • European Commission - Medical Device Sector:

http://ec.europa.eu/enterprise/medical_devices/index_en.htm

  • Guidelines relating to Medical Device Directives:

http://ec.europa.eu/consumers/sectors/medical_devices/documents/guidelines/index_en.htm

  • Global Harmonization in Medical Device Regulation. Guidelines:

http://www.ghtf.org/whatsnew.html

  • Medical Device Nomenclature Systems:

http://www.ecri.org/Products/Pages/UMDNS.aspx

http://www.gmdnagency.com/?id=nom

Medical devices

Cinical investigations under Medical Device Regulation(Regulation (EU) 2017/745)

Clinical investigation – application form under Medical Device Regulation.

Clinical investigation – Substantial modification of clinical investigation under Medical Device Regulation.

MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form

Performance studies under In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746)

Performance study - application/notification form under In Vitro Diagnostic Medical Devices Regulation (IVDR)

Performance study – Substantial modification of performance study under In Vitro Medical Device Regulation

MDCG 2024-4 Performance Study Summary Safety Report Form