Küsimused

Dear Matea

Thank you for your inquiry.

Safety reporting in clinical investigations of medical devices shall be performed in line with the requirements of the Regulation (EU) 2017/745 – Medical Device Regulation (MDR) Article 80(2):

The sponsor shall report, without delay to all Member States in which the clinical investigation is being conducted, all of the following by means of the electronic system referred to in MDR Article 73:

a) any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;

b) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;

c) any new findings in relation to any event referred to in points a) and b).

The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report. Upon request by any Member State in which the clinical investigation is being conducted, the sponsor shall provide all information referred to in paragraph 1.

Similar requirements are found in the Regulation (EU) 2017/746 on in vitro diagnostic medical devices Article 76 (2).

In general, Estonian Medical Devices Act does not specify any safety reporting requirements. All safety reporting should be prepared in accordance with the Regulation (EU) 2017/745 (MDR) and following the guidance MDCG 2020-10/1. Information about reporting forms, timelines and requirements are found in these documents.

Translation to Estonian language is not required for safety reporting regarding clinical investigations and performance studies.

All reporting shall be directed to the Estonian State Agency of Medicines via e-mail [email protected]

In case of any further concerns, please do not hesitate to contact us again.

All the best,

Merili Saar-Abroi on behalf of

Department of Medical Devices

State Agency of Medicines

[email protected]

1 Nooruse Street

50411 Tartu

Estonia

Phone: +372 737 4140

www.ravimiamet.ee

To whom it may concern,

I would like to kindly ask for information regarding the local requirements in your country for the investigational medical device.

• * is there a local requirement to submit USADEs/reportable events to NCA and ethical committee;

• * is there a local requirement to submit any line listing to NCA?

Thank you in advance for your assistance.

Kind regards, 

Matea

Matea Damičević
MPharm
Senior Pharmacovigilance Associate | Medical Reviewer
Planinska ulica 13
Zagreb, Croatia
Tel: +385 1 558 8297

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