Infokiri

H.E. Ambassador

Permanent Representation of Estonia to the EU

Rue Guimard 11-13

B-1040 Brussels

Belgium

European Commission, Grange, Dunsany, Co. Meath C15 DA39, Ireland - Office: GRAN 01/244

Tel.: direct line (+353 46) 9061 883, internal n°: 70883, switchboard: (+353 46) 9061 700

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

Director

Grange SANTE.F5 MG/dht

Subject: Invitation to a national expert to take part in the joint re-assessment of

DNV Medcert GmbH (NB 0482) to be carried out in Germany from 25 to

29 November 2024 pursuant to Regulation (EU) 2017/745

Ref.: DG(SANTE) 2024-7954

Your Excellency,

I would like to invite Ms Kristina Kübar of the Estonian Health Board to participate in the

planned assessment of DNV Medcert GmbH (NB 0482) to be carried out under the medical

devices Regulation (Regulation (EU) 2017/745) from 25 to 29 November 2024.

In addition to Ms Kübar, the assessment will include two experts from the Directorate

General for Health and Food Safety. The team coordinator will be Mr Manuel Gimenez

(telephone: +353 46 9061 883, email: [email protected]).

This invitation is being sent to you as a matter of protocol. No action is needed on your

part. A note explaining the procedures applicable to the national expert taking part in this

assessment and the necessary documents to confirm her participation are attached. These

should be filled in by the national expert and returned directly to SANTE-IRL-

[email protected].

Mr Gimenez is available to provide any additional information concerning the assessment.

The assessment reference DG(SANTE) 2024-7954 should be used in all future

correspondence.

I have the honour to be,

Yours faithfully,

(e-signed)

María Pilar Aguar Fernández

c.c. National Expert, [email protected]

Ref. Ares(2024)5999856 - 23/08/2024

Saatja: Tiiu Noobel <[email protected]>

Saadetud: 23.08.2024 16:48

Adressaat: TA Info <[email protected]>; Tiina Rootamm

<[email protected]>

Koopia: <[email protected]>

Teema: FW: National Expert Invitation - Ms Kristina Kubar

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu

saatja korral palume linke ja faile mitte avada.

Tere!

Edastan igaks juhuks ka Teviseameti üldmeilile, aga loodetavasti on

Kristina Kübar selle ilusti kätte saanud.

Parimate soovidega

Tiiu Noobel

Sekretär

Eesti Vabariigi alaline esindus EL juures

Rue Guimard 11/13, 1040 Brüssel

Tel: &#43; 32 2227 4337,

From: Teele Marzelas &lt;[email protected]&gt; Sent: Friday, August

23, 2024 3:30 PMTo: Tiiu Noobel &lt;[email protected]&gt;Subject: FW:

National Expert Invitation - Ms Kristina Kubar

From: &lt;&gt; Sent: Friday, August 23, 2024 3:19 PMTo: Esindus EL

juures üldaadress &lt;&gt;Cc: '[email protected]' &lt;&gt;;

Subject: National Expert Invitation - Ms Kristina Kubar

On behalf of the Director of DG SANTE Directorate F, María Pilar Aguar

Fernández, please find attached for your information an invitation to a

National Expert from Estonia participating in a DG SANTE mission.

The National Expert is invited to complete and sign the relevant forms

electronically and return them to before the start of the mission.

Yours sincerely,

DEBRA TABOR Assistant

1

Annex 3

MISSION EXPENSES CLAIM FORM

Name:

Countries visited:

Lead Auditor:

Email:

Departure (1st plane or train) Date: Time:

Start of First Meeting Date: Time:

End of Last Meeting Date: Time:

Time of Arrival (last plane or train) Date: Time:

*Note

1. TRAVEL EXPENDITURE * - Plane, bus, train, taxi

Doc. No. **

Type of Expense Amount Currency Reason for taking taxi

2. HOTEL EXPENDITURE (accommodation and taxes only)

Doc. No. **

Hotel Name Amount Currency Breakfast

incl.

Did you pay for all your own meals? (Yes / No)

If not, how many were paid by a third party (please

indicate below)?

No. of nights

Yes/No Lunch Dinner

Yes/No Lunch Dinner

Yes/No Lunch Dinner

Yes/No Lunch Dinner

Yes/No Lunch Dinner

Yes/No Lunch Dinner

Yes/No Lunch Dinner

Ref. Ares(2024)5999856 - 23/08/2024

2

*Continue on a second sheet if necessary. **Original documents must be numbered (1 - n) and presented in chronological order in the column.

Name:

3. OTHER EXPENDITURE *** (e.g. vaccinations, visa, internet, etc. - Justification must be given)

Doc. No. **

Type of Expense Amount Currency Reason

**Original documents must be numbered (1 - n) and presented in chronological order in the column.

***An explanatory note MUST state for such items why such payments were necessary.

CHECKLIST BEFORE YOU SEND YOUR CLAIM:

- Have you signed the claim form?

- Have you attached all originals?

- If you bought your own ticket, we need to see your boarding cards. Have you attached them?

- Have you declared all meals that you did not pay for yourself - breakfast, lunch and dinner?

- Are you claiming internet costs? If so, please give the reason for use.

- If you took a taxi, did you give the reason for doing so? In the normal course of events, taxi costs are covered by your daily allowance, and are not reimbursed as a separate expense.

However, under certain circumstances such costs may be reimbursed separately, e.g. when travel is taken early in the morning, late at night, where there is a lack of alternative public

transport or the length of the mission necessitated heavy luggage etc. If taxis were used for

reasons of this nature, this should be indicated on your expenses claim form.

Please return Annex 3 and the originals of documents to:

Please sign and date:

Mr. M. Papini

European Commission

Grange,

Dunsany,

Co. Meath, C15 DA39

Ireland

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Directorate F - Health and food audits and analysis

Director

EXPLANATORY NOTE TO NATIONAL EXPERTS TAKING PART IN AN AUDIT BY

THE DG HEALTH AND FOOD SAFETY

Information on participation and reimbursement of expenditure

1. Before your audit/inspection starts, please complete the accompanying:

• Annex 1 Declaration by National Expert.

• Annex 2 Financial Identification.

These forms can be filled electronically and returned by e-mail to [email protected]

2. After your audit/inspection please complete:

• Annex 3 Mission Expenses Claim Form.

The Mission Expenses Claim Form must be accompanied by the original documents related to:

TRAVEL EXPENDITURE (e.g. airline tickets, boarding cards, train tickets, etc.);

HOTEL EXPENDITURE (relevant bills);

OTHER EXPENDITURE which was necessary to carry out your mission (e.g. charges for vaccinations, visas).

Please note that taxi hire is only reimbursed if authorised under the Commission Rules, which are available

upon request.

Photocopies are not acceptable.

Failure to return the Mission Expenses Claim Form (Annex 3) with originals of documents, or provision of

inaccurate or incomplete Bank Account details, will seriously impede reimbursement.

Please return Annex 3 and the originals of documents for the attention of Mr M. Papini at the address below.

To:

European Commission,

Grange,

Dunsany,

Co. Meath C15 DA39,

Ireland

European Commission, Grange, Dunsany, Co. Meath C15 DA39 - Ireland - Office: GRAN 00/275

Telephone: direct line (+353-46)9061719, Switchboard (+353-46)9061700

Ref. Ares(2024)5999856 - 23/08/2024

ANNEX 1

DECLARATION

Audit Reference Number: Country:

Start Date: End Date:

I, the undersigned ………………………………………………………. ……………………………………...………

agree to participate as a national expert in an audit conducted by DG Health and Food Safety.

I declare that:

1. I am aware of and will adhere to the Code of Good Administrative Behaviour for Staff of the European

Commission in their relations with the PublicI. In particular:

I undertake to refrain from any unauthorised disclosure of information received in the line of duty, even to my

employer, unless that information has already been made public or is accessible to the public;

I declare that there is no risk of a conflict of interests between the functions I perform for my employer or the

professional activities of my close family and the tasks entrusted to me as national expert;

I undertake to inform the European Commission and my hierarchical superiors immediately of any change in

this respect during the exercise of the duties assigned to me, and

I undertake to have a duty of loyalty to the Union and be bound by the obligation to act with integrity and

discretion in the exercise of the duties assigned to me during the audit/inspection.

I undertake not to undermine the purpose of the audit/inspection by accepting certain posts or advantages

directly arising from my participation in the audit/inspection.

2. I am covered by a social security system, in particular, for illness and accident.

3. I shall take out a special travel-insurance policy providing adequate additional cover for myself and my luggage

during the inspection audit/inspection.

4. I accept that expenditure will be paid for during the audit/inspection by myself and will be reimbursed within 30

days upon presentation of the correctly completed Financial Identification Form, Claim Form and original

receipts. Most flights, and in many cases, trains will be paid in advance by the Commission services.

5. I accept that claims for travel and subsistence expenditure will be paid in EURO at the exchange rate applicable

for the month in which expenditure was incurred in accordance with the following:

Travel expenditure covers:

- rail: first class fare;

- air: not exceeding economy class fare, unless approved in the Commission Rules;

- car: on the basis of equivalent first class rail fare.

Subsistence expenditure covers:

- Daily allowance: The allowance per day for the audit/inspection is the same as for Commission officials

set in the Commission Rules and covers breakfast, two main meals, local travel, cost of telephone and all

other sundries.

- Hotel expenditure: Hotel expenses (accommodation only) are reimbursable upon presentation of the hotel

receipt for sums not exceeding the ceilings set in the Commission Rules.

Other expenditure:

Expenditure will be reimbursed upon presentation of supporting documents for vaccinations, visas, and taxis

(if authorised in the Commission Rules).

Signature: (insert [photo of] signature here)

Date:

I Annex to the Rules of Procedure of the Commission [C(2000) 3614], (OJ L 308, 8.12.2000, p. 26-34)

2

ISIKUANDMETE KAITSE http://ec.europa.eu/budget/contracts_grants/info_contracts/financial_id/financial_id_en.cfm#en

KONTO NIMI ②

IBAN/KONTONUMBER ③

RAHAÜHIK

BIC/SWIFT KONTORI KOOD ④

PANGA NIMI

LINN SIHTNUMBER

RIIK

KONTOOMANIKU

LINN SIHTNUMBER

RIIK

KOMMENTAAR

PANGA TEMPEL + PANGA ESINDAJA ALLKIRI ⑤ KUUPÄEV (kohustuslik)

KONTOOMANIKU ALLKIRI (kohustuslik)

① Märkida tuleb mitte vahenduspanga, vaid sihtpanga andmed.

② Ei peeta silmas konto liiki. Konto nimi vastab tavaliselt kontoomaniku nimele, kuid võib ka sellest erineda. ③ Märkida IBAN (rahvusvaheline pangakontonumber), kui see on panga asukohariigis kasutusel.

④ Asjakohane ainult USA (ABA-kood), Austraalia/Uus-Meremaa (BSB-kood) ja Kanada (Transit code ) puhul. Ei ole asjakohane

muude riikide puhul. ⑤ Eelistatavalt tuleks lisada koopia HILJUTISEST kontoväljavõttest. Kontoväljavõte peab kinnitama kogu

teabe, mis on esitatud väljades „KONTO NIMI”, „KONTONUMBER/IBAN” ja „PANGA NIMI”. Kontoväljavõtte lisamise korral

ei ole panga templit ega panga esindaja allkirja vaja. Kontoomaniku allkiri ja kuupäev on ALATI kohustuslikud.

TÄNAV JA MAJA

NAGU TEATATUD PANGALE

PANGAANDMED ①

TÄNAV JA MAJA

PANGAKONTORI AADRESS

FINANTSTEABE VORM

Palun kasutada vormi täitmisel SUURTÄHTI ja LADINA TÄHESTIKKU.

KONTOOMANIKU ANDMED

Ref. Ares(2024)5999856 - 23/08/2024