Vastuskiri

Tere!

Täname pöördumast.

Käesoleval juhul ei selgu, kas Teie kliendi seadmed on kantud Meditsiiniseadmete ja abivahendite andmekogusse (MSA). Vastavalt meditsiiniseadme seaduse § 26 (4) on ettevõtjatel kohustus Terviseametit teavitada meditsiiniseadmete levitamisest järgmistel juhtudel:

§ 26.   Asutusesiseselt valmistatud meditsiiniseadme valmistamisest, tellimusmeditsiiniseadme turul kättesaadavaks tegemisest, meditsiiniseadmete süsteemi, protseduuripaketi ja meditsiiniseadme esmakordsest Eestis levitamisest teavitamine ning andmete edastamine

 (4) Iga ettevõtja, kes levitab Eesti turul Euroopa Parlamendi ja nõukogu määruse (EL) 2017/745 artikli 22 kohast meditsiiniseadmete süsteemi või protseduuripaketti või Euroopa Parlamendi ja nõukogu määruse (EL) 2017/745 või nõukogu direktiivi 90/385/EMÜ aktiivseid siirdatavaid meditsiiniseadmeid käsitlevate liikmesriikide õigusnormide ühtlustamise kohta (EÜT L 189, 20.07.1990, lk 17–36) või nõukogu direktiivi 93/42/EMÜ meditsiiniseadmete kohta (EÜT L 169, 12.07.1993, lk 1–43) kohaselt liigitatud IIa, IIb või III riskiklassi meditsiiniseadet või Euroopa Parlamendi ja nõukogu määruse (EL) 2017/746 VIII lisa kohaselt liigitatud B-, C- või D-klassi in vitro diagnostikameditsiiniseadet, teavitab sellest Terviseametit kümne päeva jooksul asjaomase meditsiiniseadme esmakordsest levitamisest arvates.

Juhul, mil Teie kliendi levitatav seade ei ole nimetatud § 26 (4) ning Teie klient ei ole oma seadmeid ka vabatahtlikkuse alusel MSA-sse kandnud, ei ole tarvis teavitada ka meditsiiniseadme levitamise või tootmise lõpetamisest.

Juhul, mil Teie kliendi levitatav seade on nimetatud § 26 (4) või on seadmed kantud MSA-sse vabatahtlikkuse alusel, eeldame, et vastavalt seadusele on sellest Terviseametit MSA vahendusel teavitatud. Ka levitamisest või tootmisest lõpetamisest teavitamiseks esitatakse taotlus MSA-s.

Kui tegemist on juhuga, mil Teie klient seadet enam Eestis ei levita, kuid seadme tootmisega jätkatakse, on tegemist levitamise lõpetamisega. Kui seadet ka enam ei toodeta, tuleks teavitada tootmise lõpetamisest. 

Teie kliendi olukorrale vastava taotluse esitamiseks tuleks sisse logida MSA-sse ning valida ülevalt paneelist käsk ’Uus toiming’. Alamüksuse ’Seade’ all on võimalik esitada taotlus ’Lõpeta meditsiiniseadme levitamine’ või ’Teata tootmise lõpetamisest’. Korrektse taotluse korral kinnitatakse see tavaliselt mõne nädala jooksul.

Inglise keeles oleks meie vastus levitajale/tootjale järgmine:

Thank You for Your inquiry.

Currently it is not clear whether the medical device(s) in question are registered in the Estonian Medical Device Database (EMDDB). The obligation to notify the Health Board via EMDDB is specified in the Medical Devices Act § 26 (4):

§ 26.  Notification of manufacture of medical devices manufactured within institution, making custom-made medical devices available on market, distribution of medical device or system and procedure pack of medical devices in Estonia for first time and transmission of data

(4) Every undertaking who distributes on the market of Estonia a system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745 of the European Parliament and of the Council or a class IIa, IIb or III medical device classified according to Regulation (EU) 2017/745 of the European Parliament and of the Council or Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.07.1990, p 17–36) or Council Directive 93/42/EEC concerning medical devices (OJ L 169, 12.07.1993, p 1–43) or class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746 of the European Parliament and of the Council, shall notify the Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

If Your device is not listed in the § 26 (4) and You have not notified about the distribution in the EMDDB on a voluntary basis, You do not have to report discontinuation of distribution or manufacturing of the device(s) in question.

If Your device is registered in the EMDDB, You can report discontinuation of distribution or manufacturing of the device(s) via EMDDB. The application should be made by the (legal) person responsible for the initial notification of distribution in the EMDDB.

Please note that we distinguish two types of reports – discontinuation of distribution should be chosen in cases where You do not distribute the device in Estonia, however, the manufacturing of the device has not been discontinued. Discontinuation of manufacturing indicates that the device is not distributed in Estonia anymore and the manufacturing of the device has been disconinued alltogether.

To submit a discontinuation report in the EMDDB, please log in to the EMDDB and select ’New Application’ located at the top panel of the website. Next, under subsection ’Medical device model’, You can choose the application either ’Report discontinuation of distribution’ or ’Report discontinuation of manufacturing’ according to Your situation regarding the device(s). In case of a correct application, the application will usually be approved within a few weeks.

Lisaküsimuste korral olete alati oodatud meie poole uuesti pöörduma.

Lugupidamisega,

Tere

Minu klient küsib järgmist seoses meditsiiniseadmete teavitamisega (selguse huvides jätan tõlkimata):

Please provide information on medical device discontinuation.

Is there a requirement to notify/inform the EE HA about the discontinuation of medical device i.e. if the product will no longer be shipped to Estonia (not related to safety/quality issues).

If yes, what are the timelines for it, who should be doing the reporting and is there any specific info that is required for the notification?

Lugupidamisega ja ette tänades

Diana Astover

Sr. Regulatory Affairs & Pharmacovigilance Specialist | Insuvia

Excellence in Pharmacovigilance & Regulatory Affairs

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