[EU MDR/IVDR] EUDAMED 모듈 별 제조자 요구사항

EUDAMED의 모듈은 아래와 같이 6개로 구성되어 있다. 

(현재는 ACT, UDID 두 개의 모듈만 활성화 되어 있는 상태)

- Actor registration (ACT)

- UDI/Devices registration (UDID)

- Notified bodies and certificates (CRF)

- Clinical investigations and performance studies (CIPS)

- Vigilance and post-market surveillance (VGL)

- Market surveillance (MSU)

 

EUDAMED의  모듈별로 제조자가 수행해야하는 요구사항은 아래와 같다:

1) Actor Registration Module (ACT)

Stakeholder	Stakeholder Task	Eudamed Requirement (Eudamed shall allow/enable)	Module	Legal Basis (MDR)	Legal Basis (IVDR)
Manufacturer	Submit actor data for registration and for accessing Eudamed	Enable manufacturer to submit its details for registration and to get a SRN created by Eudamed after validation by a CA	ACT	Article 31(1, 2, 3) Article  30(1) Annex VI Part A Section 1	Article 28(1) Annex VI Part A Section 1
	Update actor own details	Enable manufacturer to update its details within one week of any change	ACT	Article 31(4)	Article 28(4)
	Confirm accuracy of its actor data in Eudamed	Enable manufacturer, no later than 1 year after submission and every second year thereafter, to confirm the accuracy of its actor data in Eudamed	ACT	Article 31(5)	Article 28(5)

2) UDI/Devices Registration Module (UDID)

Stakeholder	Stakeholder Task	Eudamed Requirement (Eudamed shall allow/enable)	Module	Legal Basis (MDR)	Legal Basis (IVDR)
Manufacturer	Submit Basic UDI-DI and associated UDI-DI data	Enable manufacturer to provide to the UDI database the Basic UDI-DI assigned to a device together with the other UDI-DI core data elements related to that device	UDID	Article 29(1) Annex VI Part B	Article 26(1) Annex VI Part B
	Submit device data	Do not allow entering UDI-PIs and commercially confidential product information	UDID	Article 28(2)	Article 25 in IVDR refers to Article 28 in MDR
	Update device data	Enable manufacturer to enter device details together or after having submitted Basic UDI-DI and UDI-DI data	UDID	Article 29(4) Annex VI Part A section 2	Article 26(3) Annex VI Part A Section 2
	View (Basic) UDI-DI data and Device data	Enable manufacturer to update device details to keep them up-to-date with changes	UDID	Article 29(4)	Article 26(3)
	Upload of Basic UDI-DI, UDI-DI and device data	Before placing a device on the market, Enable to ensure that the Basic UDI-DI assigned to a device together with the other core data elements related to that device are correctly submitted and transferred to the UDI database Enable to verify device data are well provided and up-to-date	UDID	Article 27(3) Article 29(4)	Article 24(3) Article 26(3)
	Download of Basic UDIDI, UDI-DI (including for systems and procedure packs) and device data	Allow for automatic uploads of their own Basic UDI-DI and related UDI-DI data elements and device data	UDID	Article 28(4)	Article 25 in IVDR refers to Article 28 in MDR
	Get nomenclature data	Allow for automatic downloads of any registered Basic UDI-DI and related UDI-DI data elements and device data	UDID	Article 28(4)	Article 25 in IVDR refers to Article 28 in MDR

3) Notified Bodies and Certificates (CRF)

Stakeholder	Stakeholder Task	Eudamed Requirement (Eudamed shall allow/enable)	Module	Legal Basis (MDR)	Legal Basis (IVDR)
No Requirement for the Manufacturer

4) Clinical Investigations and Performance Studies(CIPS)

Stakeholder	Stakeholder Task	Eudamed Requirement (Eudamed shall allow/enable)	Module	Legal Basis (MDR)	Legal Basis (IVDR)
Manufacturer	Submit Periodic Safety Update Reports (PSURs)	Enable submission of PSURs for [class III or implantable medical devices]/[class D in vitro diagnostic devices] to the NB involved in the conformity assessment of the devices	VGL	Article 86(2) Article 92(1d)	Article 81(2) Article 87(1d)
	Report a Serious Incident (SI)	Enable to report to the relevant CA(s) a SI occurring within the Union market for a device made available on the Union market (also before MDR and IVDR dates of application).	VGL	Article 87(1a) Article 92(1a) Article 83(4) Article 120(3)	Article 82(1a) 87(1a), 78(4) Art 110(3)
		Transmit the reported SI (for all legislations and before) to the CA of the MS where the incident occurred and to the NB(s) that issued the certificate(s) of the concerned device where applicable (only MDR/IVDR).	VGL	Article 92(5) Article 92(9)	Article 87(5) Article 87(9)
		Enable the submission of an initial incomplete SI report in order to ensure timely reporting, and then allow update of the report (follow-up) to complete it later	VGL	Article 87(6)	Article 82(6)
		Enable to provide to the CA a final report on a reported serious incident	VGL	Article 89(5) Article 92(1a)	Article 84(5) Article 87(1a)
	Report a Field Safety Corrective Action (FSCA)	Enable to report a FSCA for devices made available in the Union market (also before MDR and IVDR dates of application), including FSCA undertaken in a third country if the reason for the FSCA is not limited to the devices made available in the third country.	VGL	Article 87(1b) Article 87(8) Article 92(1a) Article 83(4) (+ Article 120(3))	Article 82(1b) Article 82(8) Article 87(1a) Article 78(4) (+Art 110(3))
		Transmit the reported FSCA to the CAs of the MSs in which the FSCA is being or to be undertaken, to the CA of the MS where the MF is established, and to the NB(s) that issued the certificate(s) of the concerned device	VGL	Article 92(7) Article 92(9)	Article 87(7) Article 87(9)
		Enable to provide to the CA a final report on a reported FSCA.	VGL	Article 89(5) Article 92(1a)	Article 84(5) Article 87(1a)

5) Vigilance and post-market surveillance (VGL)

Stakeholder	Stakeholder Task	Eudamed Requirement (Eudamed shall allow/enable)	Module	Legal Basis (MDR)	Legal Basis (IVDR)
Manufacturer	Submit/Enter a Field Safety Notice (FSN)	Enable the submission of a FSN relating to FSCA(s)	VGL	Article 89(8) Article 92(1e)	Article 84(8) Article 87(1e)
	Submit PSR	Enable the submission of a PSR for similar SIs that occur for the same device/device type and for which the root cause has been identified or a FSCA has been implemented or for incidents that are common and well documented.	VGL	Article 87(9) Article 92(1b)	Article 82(9) Article 87(1b)
		Transmit the submitted PSR to the concerned CA(s)* and to the NB(s) that issued the certificate(s) of the concerned device. * The CA (when the incidents occurred only in one MS) or the CAs in agreement with the PSR possibility and participating in a coordinated assessment (when the incidents occurred in two or more MSs), and the CA of the MS in which the MF is established.	VGL	Article 92(8) Article 92(9)	Article 87(8) Article 87(9)
	Submit a Trend Report (TR)	Enable submission of a TR (report any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side effects that could have a significant impact on the benefit-risk analysis).	VGL	Article 88(1) Article 92(1c)	Article 83(1) Article 87(1c)
		Transmit submitted TR to the CA(s) of the MS where the incident on which the trend is based and to the NB(s) that issued the certificate(s) of the concerned device(s).	VGL	Article 92(6) Article 92(9)	Article 87(6) Article 87(9)

6) Market Surveillance (MSU)

Stakeholder	Stakeholder Task	Eudamed Requirement (Eudamed shall allow/enable)	Module	Legal Basis (MDR)	Legal Basis (IVDR)
No Requirement for the Manufacturer

1년에 한 개씩 글을 작성하는 기분이다. (매 6-7월...) 화이팅..