Kiri

Dear Matthias,

Thank you for your reply.

I think we will have time for a bilateral teams call on 6 August at 11:00.

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

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

Dear Maarika,

I think that there are experts missing and everyone has too much workload at the moment. Therefore, not mandatory things, like SER, have a low priority for some CAs.

I would recommend a kind of expert panel to evaluate the SERs, including CAs and maybe other experts from different fields.

If the whole thing were given a more official framework, there might also be the possibility of funding etc.

August sounds great!

Do you have time from 5^th to 9^th August?

Maybe 6. August 10:00 Vienna time, 11:00 Tallin time?

Best,

Matthias

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

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

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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This message and any attached files are confidential and intended solely for the addressee(s). Any publication, transmission or other use of the information by a person or entity other than the intended addressee is prohibited. If you receive this in error please contact the sender and delete the material. The sender does not accept liability for any errors or omissions as a result of the transmission.

Firma & Rechtsform: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

Sitz: Spargelfeldstraße 191, 1220 Wien

Firmenbuchnummer: FN 223056z

Firmenbuchgericht: Handelsgericht Wien

Diese Nachricht und allfällige angehängte Dokumente sind vertraulich und nur für den/die Adressaten bestimmt. Sollten Sie nicht der beabsichtigte Adressat sein, ist jede Offenlegung, Weiterleitung oder sonstige Verwendung dieser Information nicht gestattet. In diesem Fall bitten wir, den Absender zu verständigen und die Information zu vernichten. Für Übermittlungsfehler oder sonstige Irrtümer bei Übermittlung besteht keine Haftung.

This message and any attached files are confidential and intended solely for the addressee(s). Any publication, transmission or other use of the information by a person or entity other than the intended addressee is prohibited. If you receive this in error please contact the sender and delete the material. The sender does not accept liability for any errors or omissions as a result of the transmission.