ANNEX 7
AUTHORITIES RESPONSIBLE FOR THE IMPLEMENTATION OF MDR / IVDR
Member State / Country: Estonia notifies,
in accordance with Article 101 of Regulation (EU) 2017/745 on medical dcvices and
Article 96 ofRegulation (EU) 20 17/746 on in vitro diagnostic medical devices,
the following authority(ies)’ responsible for the impiementation of the Regulations
with the effect of 1 January 2025:
Field of competence:
Medical devices
Narne of the authority:
State Agency of Medicines
Contact details, including postal address and e-mail:
Medical Deviccs Department, State Agency ofMedicines
Nooruse 1, Tartu, Estonia, 50411
+372 737 4140
[email protected]
On behalf of the notifying authority:
[signature ofa person authorised to make the notification to the Commission, in accordance
i’ith any applicable national / internal proceduresJ
Signature:
Name:
Affihiation: Ministry of Social Affairs of Estonia
Date: 19.11.2024
If more than one authority is responsible for impiementation of MDR / IVDR, the table should be copied and
fihled out accordingly, indicating each time the relevant field of cornpctencc.
ANNEX 2
MEDICAL DEVICE COORDINATION GROUP (MDCC)
NOTIFICATION BY EU MEMBER STATE
OF APPOINTED MEMBERS AND ALTERNATES
Member State: Estonia hereby notifies
the following experts to the MDCG,
appointed in accordance with Article 103(2) of Regulation (EU) 2017/745 on medical
devices,
with the effect of 1 January 2025:
(i) in the capacity ofa member with expertise in the field of medical devices’:
First name and surname:
PIRET PÖIKLIK
Name of the authority ofaffihiation:
State Agency of Medicines
Contact details, including postal address and e-mail:
Medical Devices Department, State Agency ofMedicines
Nooruse 1, Tartu, Estonia, 50411
+372 737 4140
[email protected]
(ii) in the capacity ofan alternate with expertise in the field of medical devices2:
First name and surname:
KRISTINA KUBAR
Name of the authority ofaffihiation:
If the same person has been also appointed as a rnember with expertise in the field of in-vitro medical devices,
then the name ofthat person should be repeated in point (iii) below.
2
If the sarne person has been also appointed as an alternate with expertise in the ficld of in-vitio medical
devices, then the name ofthat person should be repeated in point (iv) bclow.
State Agency of N’Iedicines
Contact details, including postal address and c-mail:
Medical Devices Department, State Agency of Medicines
Nooruse 1, Tartu, Estonia, 50411
+372 737 4140
[email protected]
(iii) in the capacity of a member with expertise in the field of iii vitro diagnostic medical
devices:
First name and surname:
PIRET PÖIKLIK
Name of the authority ofaffihiation:
State Agency of Medicines
Contact details, including postal addrcss and e-mail:
Medical Devices Department, State Agency ofMedicines
Nooruse 1, Tartu, Estonia, 50411
+372 737 4140
[email protected]
2
(iv) in the capacity of an alternate with expertise in the field of iii vitro dia2nostic medical
devices:
First name and surnarne:
EGLE AUDOVA
Name of the authority ofaffiliation:
State Agency of Medicines
Contact details, including postal address and e-mail:
Medical Devices Department, State Agency ofMedicines
Nooruse 1, Tartu, Estonia, 50411
+372 737 4140
[email protected]
On behalf of the notifying authority:
[signature ofa person authorised to make the notijication to the Comrnission, in accordance
with any applicable national / internal proceduresJ
77
Signature:
/Anniki Lai
Name:
/
Affihiation: Ministry of Social Affairs ofEstonia
Date: 19.11.2024
3
REPUBLIC OF ESTDNIA
MIN ISTRY OF S0cIAL AFFAIRS
Estelle Goeger
European Commission
DG for Internal Market, Industry,
Entrepreneurship and SMEs Our ref. 19.11.2024 No 1.4-2/2928-1
[email protected]
Avenue d’Auderghem 45
B-1049 Brussels, Beigium
Governance of the Medical Device Regulations
Dear Ms Goeger
In continuation of the nomination letter sent out on 15 September 2017, please find attached
renewed nomination Ietters from the Ministry of Social Affairs of Estonia.
Yours sincerely,
nniki Lai
Deputy Secretary General on Health
Encl. nomination letters (Annex 2, Annex 5, Annex 7)
Tiina Rootamm +37253675311
[email protected]
Suur-Ameerika 1/10122 Tallinn / ESTONIA/ +372 626 9301 /
[email protected] / www.sm.ee / Reg. no
70001952
ANNEX 5
COMMITTEE ON MEDICAL DEVICES (comitology committee)
NOTIFICATION OF DESIGNATED REPRESENTATIVES
Member State / Country’: Estonia hereby notifies
the following representative(s)2 to the Committee on Medical Devices, established by
Article 114(1) of Regulation (EU) 20 17/745 on rnedical devices, in connection with
Article 107(1) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices with the
effect of 1 January 2025:
First narne and surname:
PIRET PÖIKLIK
Name of the authority of affihiation:
State Agency of Medicines
Contact details, including postal address and e-mail:
Medical Devices Department, State Agency of Medicines
Nooruse 1, Tartu, Estonia, 50411
+372 737 4140
[email protected]
On behalf of the notifying authority:
[signature ofa person authorised to make the notification to the Comrnission, in accordance
with any applicable national / internalprocedures]
Signature:
Name: %ki Lai
Affiliation: Ministry of Social Affairs of Estonia
Date: 19.11.2024
Participation in the cornitology committee of a non-EU country is deterrnined by the rules of any relevant
agreelnent in place between the EU and that Country, and the designation ofrepresentatives to the Comrnittee
on Medical Devices is without prejudice to those rules.
2
If inore than one representative is notified, the table should be copied and flhled out accordingly.
Appointment of one or more representatives does not affeCt the voting rules in accordance with Regulation
(EU)No 182/2011.