Vastuskiri

Dear Dr. Coyle,

Thank You for Your inquiry.

As per the Article 58 of the the Regulation (EU) 2017/746 (IVDR), the sponsor of the study shall notify the competent authority of any studies involving companion diagnostics using only left-over samples. Further, according to the Estonian Medical Devices Act § 21¹ (4) point 2 , the sponsor must notify the Health Board at least ten days in advance if the plan to conduct a CDx study using only left-over samples:

“(4) The sponsor notifies the Health Board at least ten days in advance if they plan to conduct:

              1) [---]

2) a performance study specified in subsection 2 of Article 58 of Regulation (EU) 2017/746 of the European Parliament and of the Council involving companion diagnostics using only left-over samples.“

Please be aware that even when left-over samples are used, there might still be situations where Article 58(1) applies.

Best regards,

Dear Sir/Madam,

I am seeking confirmation of the Notification requirements for a Clinical Performance Study, which is subject to IVDR (EU) 2017/746. It is a non-interventional performance study which involves a companion diagnostic using left-over samples (IVDR Article 58(2)). The device is not yet CE Marked.

Having reviewed the information on your website, including the Medical Devices Act § 22, the Notification requirements for this type of performance study do not seem clear to me.

Can you advise if the notification requirements for this type of study are the same as studies which fall under IVDR Article 58(1) or if a study using left-over samples only would be exempt from Notification requirements?

Thank you in advance for your help and support.

Kind Regards

Mhairi

Lugupeetud härra/proua,

Otsin kinnitust kliinilise toimivuse uuringu teavitamisnõuete kohta, mille suhtes kohaldatakse in vitro diagnostika meditsiiniseadmeid käsitlevat määrust (EL) 2017/746. Tegemist on mittesekkuva toimivusuuringuga, mis hõlmab personaliseeritud ravimispetsiifilist diagnostilist kompleksi, milles kasutatakse jääkproove (in vitro diagnostika meditsiiniseadmeid käsitleva määruse artikli 58 lõige 2). Seadmel ei ole veel CE-märgist.

Olles tutvunud oma veebisaidil oleva teabega, sealhulgas meditsiiniseadmete seaduse §-ga 22, ei tundu seda tüüpi toimivusuuringu teavitamisnõuded mulle selged

Kas oskate soovitada, kas seda liiki uuringutest teatamise nõuded on samad, mis in vitro diagnostika meditsiiniseadmeid käsitleva määruse artikli 58 lõike 1 alla kuuluvatel uuringutel, või kas ainult ülejäänutest proove kasutav uuring oleks teatamiskohustusest vabastatud?

Tänan teid ette abi ja toetuse eest.

Heade soovidega

Mhairi

Mhairi Coyle, PhD
Clinical Affairs Specialist, Global Clinical Affairs Operations

QIAGEN

Sample to Insight

QIAGEN Manchester Ltd (Remote)

[email protected]
www.qiagen.com

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