Ethnicities and races Clinical Trials medical devices in Europe

RegulatoryUS_EU

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Hi all,

I am writting this message because we have a question about races and ethnicities to be recorded in clinical trials in the EU

In the US there are specific guides (https://www.fda.gov/media/98686/download and (broken link removed) -ethnicity-data-clinical-trials) that require clinical trial sponsors that “race” and “ethnicity” data should be collected as part of the clinical trial (e.g., collect if subjects are hispano, latino, asian, etc)

I would like to ask you ifyou know if in Europe it is also necessary to collect this information on "race" and "ethnicity" and if yes, if there is a reference guideline.

We are not familiar with any guideline, but perhaps it is necessary to collect some information related to "race" and ethnicity. If so, Do you know how it is shuld collected? which races/ethnicities should be collected (for example "caucasian" may not be used in the EU)


thank you!
 

Talia

Involved In Discussions
When clinical investigations are conducted under the MDR (which is based on ISO 14155:2020), they will also need to comply with:
1. any applicable common specifications, defined in MDR Article 2(71)
2. any applicable requirements of the national competent authority/authorities and ethics committee(s).
3. applicable European harmonized standards
4. other relevant international standards and European and national guidance documents.

It is also important that sponsors are fully versed in the state of the art in medical practice related to the device technology involved, including relevant practice guidelines or other device-related guidance.

There are also other European guidance documents on which MDR is based:
MEDDEV 2.7/4 on the need for, and general principles of, clinical investigations
MEDDEV 2.7/2 Rev 2 on clinical investigation validation and assessment by competent authorities
MEDDEV 2.7/3 Rev. 3 on serious adverse event (SAE) reporting

To make a long story short, while the MDR doesn't specifically mentions the collection of race and ethnicity it might be required by other relevant guidelines (as mentioned above) and especially in terms of the specific medical field/SotA
 
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