Kiri

Tere

Saadan vastused Teie küsimustele, lisades vastused otse teksti sisse (kollasena).

•             Since IVRD application (May 2022), is there still local specificities required by NCA (National Competent Authorities) or expected by NCA? - IVDR is directly applicable and there are no additional requirements required by NCA.

•             In the survey dating 2022, you answered that for initial reporting, additional documents (beside FSN and Annex IV) are needed.

Can you precise which documents are requested and what is the timeline to provide them to your NCA?

INITIAL FIELD SAFETY CORRECTIVE ACTION (FSCA) and FSN are the main documents. Manufacturer could include all relevant documents necessary for the National Competent Authority to monitor the FSCA – e.g. distribution list, response forms, but it is not necessary and at the manufacturer´s discretion.

There is no timeline written in local regulations.

•             The FSN translation to Estonian depends if the information is intended for ordinary users (not professional user). As the bioMérieux products are all for intended professional use, does the translation requirement apply to Estonia?

According to Medical Devices Act § 27.  Registration of adverse incident and field safety notice

(2) The field safety notice is drawn in Estonian with regard to medical devices made available on the Estonian market. Initial field safety notice submitted for an urgent situation may also be in English.

Our positsion is that the FSN must be in an language that the potential (professional) user can understand. We accept an English safety notice in situations where it is not practical to translate it. For example, in the case of a very narrow user base and specific terminology, when the content may suffer in translation.

•             Does the Customer Notification require NCA approval of FSN? Is there a timeline written in local regulation ? Does it apply to English or local language version of the FSN or both?

Customer Notification does not require NCA approval of FSN.

(It is recommended that MANUFACTURERs should provide a draft of the Field Safety Notification to a relevant National Competent Authority, e.g. where the MANUFACTURER or the AUTHORISED REPRESENTATIVE has his registered place of business, where most of the affected devices are on the market or any other appropriate National Competent Authority.

Normally, the MANUFACTURER should allow a minimum of 48 hours for receipt of comment on the Field Safety Notification unless the nature of the FSCA dictates a shorter timescale e.g. for SERIOUS PUBLIC HEALTH THREAT.)

There is no timeline written in local regulations.

•             In the follow-up report, there is a possible request for additional documents – what kind of documents?

Are these documents to be provided by BMX or is it more an update on the implementation (customer and product reconciliation)?

What is the timeline to provide these documents?

This notification should include all relevant documents necessary for the National Competent Authority to monitor the FSCA – e.g. distribution list, response forms but there is no certain timeline.

We do not know what „BMX“ stands for.

•             Is there an official closure from NCA ( official email or letter)? What are the  local closure criteria? If yes, what are the criteria? ( examples from the list:

o             Reach target % customer return - % of customer approvals is not regulated, rather it is a question of the manufacturer´s own quality managment system. Usually good practice is three contact attempts.

o             Send final report to NCA - Yes

o             Receive official closure letter from NCA - If the manufacturer wants to (mentions it) then we send an acknowledgement of receipt of the report

to the sender.

o             Complete actions on the product

o             Complete reconciliation at product stock level

o             Close any CAPA related to the FA

o             If Other:  please describe. - Local closure criteria depends on the incident and what is the corrective action – recall, changes in IFU, software upgrade etc. The MANUFACTURER or other responsible on his behalf should inform the coordinating

Competent Authority once the FSCA has been completed in both, the EEA, Switzerland and Turkey. This should include information on the effectiveness of the action per country involved (e.g., percentage of devices recalled)

Kui teil on lisaküsimusi, võtke meiega kindlasti ühendust.

Lugupidamisega

Jaak Raud

peaspetsialist

meditsiiniseadmete osakond

+372 5561 0969

[email protected]

Käesolev kiri on konfidentsiaalne ning mõeldud kasutamiseks kirja päises nimetatud isikule/asutusele. Käesoleva kirja mistahes viisil kasutamine või kopeerimine isiku poolt, kes ei ole märgitud selle adressaadiks, on keelatud. Kui te olete saanud käesoleva kirja ekslikult, palume sellest koheselt teavitada kirja saatjat ning kustutada saadud kiri koos kõikide lisadega.

Tere

Seoses sellega, et üks meditsiiniseadmete tootja (bioMerieux) plaanib tsentraliseerida FSCA raporteerimise Euroopas enne EUDAMED Go Live-i on projektijuhtidel mõned küsimused mis puudutavad Eesti nõudeid.

Kas Te palun saaksite mind sellega aidata?

•             Since IVRD application (May 2022), is there still local specificities required by NCA (National Competent Authorities) or expected by NCA?

•             In the survey dating 2022, you answered that for initial reporting, additional documents (beside FSN and Annex IV) are needed.

Can you precise which documents are requested and what is the timeline to provide them to your NCA?

•             The FSN translation to Estonian depends if the information is intended for ordinary users (not professional user). As the bioMérieux products are all for intended professional use, does the translation requirement apply to Estonia?

•             Does the Customer Notification require NCA approval of FSN? Is there a timeline written in local regulation ? Does it apply to English or local language version of the FSN or both?

•             In the follow-up report, there is a possible request for additional documents – what kind of documents?

Are these documents to be provided by BMX or is it more an update on the implementation (customer and product reconciliation)?

What is the timeline to provide these documents?

•             Is there an official closure from NCA ( official email or letter)? What are the  local closure criteria? If yes, what are the criteria? ( examples from the list:

o             Reach target % customer return

o             Send final report to NCA

o             Receive official closure letter from NCA

o             Complete actions on the product

o             Complete reconciliation at product stock level

o             Close any CAPA related to the FA

o             If Other:  please describe.

Lugupidamisega

Mart Saluvere

Diamedica OÜ

Tere

Paluksin Teie käest abi FSCA aruandlusnõuete osas.

Kas seoses kohaliku seadusandluse muutumisega peaks kollasega märgitud vastustes nüüd midagi korrigeerima?

Lugupidamisega

Mart Saluvere

Diamedica OÜ

Tere

Lisasin mõningaid selgitusi ja täiendusi otse teie teksti sisse (kollasena).

Kui jooksvalt tekib veel küsimusi või arutamist vajavaid kohti, pöörduge julgelt, otsime koos vastuseid.