Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, Any insight appreciated. I feel like I am missing something in my research in understanding clinical trial for med device under new EU MDR. Is an SRN required for manufacturer and importer/sponsor? What regulations apply for med device clinical trial other than the 2017 EU MDR? Thank you.

Hello Anon,

There is not a requirement to have a Single Registration Number (SRN) for conducting clinical trials at the present time, though it might be required and would be helpful.  Because the clinical investigation module is not available yet, it is not clear what will be required as part of this module and the content.  From the regulation, it would not appear a SRN will be required, but because it will be part of EUDAMED maybe or maybe not.  The SRN is needed for Actor Registration including Manufacturer, Importer, etc., a Sponsor of a clinical investigation is not considered an Actor.  There is also the Clinical Trial regulation (CTR) 536/2014, but not clear how much of this will be applied to medical devices.  If conducting a clinical trial in the European Union for a medical device I would definitely comply with EU MDR, CTR, and EN ISO 14155.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 21-Nov-2022 11:57
From: Anonymous Member
Subject: EU Medical Device Clinical Investigation - SRN

This message was posted by a user wishing to remain anonymous

Hello, Any insight appreciated. I feel like I am missing something in my research in understanding clinical trial for med device under new EU MDR. Is an SRN required for manufacturer and importer/sponsor? What regulations apply for med device clinical trial other than the 2017 EU MDR? Thank you.

You must follow EU MDRs CT rules as well as MDRs safety and performance rules, ISO14155, and any unique local country requirements.  Depending on whether your product delivers drug or not, you may also need to follow EU drug trial requirements.  If your data is coming back to the US for US submission and marketing approval, your trial may include US sites, in this case you may need to also comply with certain US regulations (hence SR vs NSR, which is US only), it depends.

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Indianapolis IN
United States
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Original Message:
Sent: 21-Nov-2022 11:57
From: Anonymous Member
Subject: EU Medical Device Clinical Investigation - SRN

This message was posted by a user wishing to remain anonymous

Hello, Any insight appreciated. I feel like I am missing something in my research in understanding clinical trial for med device under new EU MDR. Is an SRN required for manufacturer and importer/sponsor? What regulations apply for med device clinical trial other than the 2017 EU MDR? Thank you.

Hello Anon,

SRN is not listed in the Clinical Investigation form (MDCG 2021-8 Annex 1) that should be used until EADAMED is fully functional.

Annex 1 also includes an "Appendix of documents to attach" and that appendix lists "Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/ personal information" so be aware of any General Data Protection Regulation (GDPR) requirements.

Links to MDCGs and GDPR text:
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02016R0679-20160504&qid=1532348683434

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Mark Mortellaro
Sr. Principal Regulatory Scientist
Clarksburg MD
United States
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Original Message:
Sent: 21-Nov-2022 11:57
From: Anonymous Member
Subject: EU Medical Device Clinical Investigation - SRN

This message was posted by a user wishing to remain anonymous

Hello, Any insight appreciated. I feel like I am missing something in my research in understanding clinical trial for med device under new EU MDR. Is an SRN required for manufacturer and importer/sponsor? What regulations apply for med device clinical trial other than the 2017 EU MDR? Thank you.