Clinical Trial outside of EU Member States

Teisin

Registered
Hi all,

I'm a bit confused when trying to solve the problem, is clinical trial outside on EU approved?

(64): "The rules on clinical investigations should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of clinical investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of clinical investigations conducted outside the Union in accordance with international guidelines to be accepted within the Union. In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects. "

BUT

Article 62 4a): "the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated; "

I appreciate your answers!
 

Aliken

Involved In Discussions
Hi Teisin,

Yes, it is possible to perform clinical trials outside the EU. See:

Article 80:
3. The sponsor shall also report to the Member States in which the clinical investigation is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a clinical investigation is performed under the same clinical investigation plan as the one applying to a clinical investigation covered by this Regulation by means of the electronic system referred to in Article 73.

Annex XV (1.8) states that:
identification of the Member States and third countries in which the clinical investigation is to be conducted as part of a multicentre or multinational study at the time of application;

See also MDCG_2021-8_annex1_0 (1.6)

If relevant, you should still ask your NB whether a non-EU clinical study could be performed even if it is a single-center study (no other studies in the EU are involved
 
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