Kiri

Dear Sai Kiran,

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.

For post-market clinical follow up (PMCF) investigations of CE-marked devices used within the intended use covered by the CE-marking, reporting requirements of MDR Article 80(5) and (6) apply.

The National Competent Authority for medical devices in Estonia is Health Board and all reporting shall be directed to us via e-mail mso@terviseamet.ee

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.

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

All the best,

Dear Merili Saar-Abroi,

"By Aggregate report we mean any kind of report, for example Annual Safety Report, Periodic Line Listing Report etc. Thank you for your time. A prompt response would be highly appreciated." 

Thanks & Regards

Sai Kiran Topa

Safety Science Analyst

E: saikiran.topa@fortrea.com

M: +91 7093615048 | fortrea.com

Dear Sai Kiran,

Thank You for Your enquiry.

The medical device regulations do not specify such term as ’aggregate report’. Please specify the questions nature as per medical device regulations terminology.

All the best,

Dear Sir/ Madam,

Hope this email finds you well.

Could you please provide us the contact information (preferably email) for regulatory authority and Pharmacovigilance for Estonia.

In addition, could you please provide the following information for  post-marketing Medical device Clinical Trials in Estonia.   

Post-marketing Medical Device Clinical Trials (AGGR requirements):

• Destination (Agency Name):

• Requirements:

• Aggregate Report Type:

• Timelines:

• Translation required for Aggregate Reports in regional language ? (Yes/No)

Thanks & Regards

Sai Kiran Topa

Safety Science Analyst

E: saikiran.topa@fortrea.com

M: +91 7093615048 | fortrea.com

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