Kiri

Dear Matthias,

Thank you for your letter.

Unfortunately, I will not be able to attend the CAMD meeting in Paris on 10 July.

I am going on holiday soon, would it be convenient for you to have a bilateral teams call in August, for example?

It has been strange to me that only about 5 countries responded to the SER, and as Iceland responded that they had no resources, which was predictable, but why do most countries not present their assessments.

What do you have in mind that urgent need for a change?

Kind regards,

Maarika Ojala

Chief Specialist

Department of Medical Devices

+372 5400 4028

[email protected]

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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Dear Maarika,

We are very happy that you brought the topic SER into discussion.

As we are one of the few that process and respond to every SER, we also see an urgent need for a change.

Do you have time for a bilateral teams call next week or are you coincidentally in Paris on the 10^th of July for the CAMD meeting?

Best regards,

Matthias

From the AT Competent Authorities

AGES – Gesundheit für Mensch, Tier und Pflanze

Dr. Matthias Scherer, MSc

Abteilungsleiter | Head of Department
Medizinproduktemarktüberwachung | Medical Device Vigilance (MDVI)

Institut Überwachung | Institute Surveillance

Medizinmarktaufsicht (MEA) | Medical Market Surveillance

BASG – Bundesamt für Sicherheit im Gesundheitswesen | Federal Office for Safety in Health Care

AGES – Österreichische Agentur für Gesundheit und Ernährungssicherheit | Austrian Agency for Health and Food Safety

Traisengasse 5, 1200 WIEN

Tel. +43 (0)5 0555-36453

www.ages.at

www.basg.gv.at

Firma & Rechtsform: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

Sitz: Spargelfeldstraße 191, 1220 Wien

Firmenbuchnummer: FN 223056z

Firmenbuchgericht: Handelsgericht Wien

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