When can a clinical investigation begin for a Class I device after obtaining Ethics Committee approval?

When can a clinical investigation begin for a Class I device after obtaining Ethics Committee approval?

• A. Immediately in a new investigational site
• B. Immediately after the date of notification
• C. Sixty days after the date of notification
• D. Following compliance with Annex IX of the MDD

Answer: (B)

The correct choice is that a clinical investigation for a Class I device can begin immediately after the date of notification. This is in line with the regulatory framework that governs clinical investigations for medical devices, which typically allows for prompt initiation following the necessary approvals. For Class I devices, the regulatory pathway is generally less stringent compared to Class II or III devices, allowing for faster access to the market and quicker initiation of clinical trials. Once Ethics Committee approval is obtained, the investigation can commence without the long waiting periods required for higher-risk classifications. This rapid response reflects the lower risk profile associated with Class I devices, making it efficient to gather necessary clinical data. The other options detail various conditions or time frames that are relevant to different classes of devices or scenarios and are not applicable to Class I devices under these specific circumstances.

The correct choice is that a clinical investigation for a Class I device can begin immediately after the date of notification. This is in line with the regulatory framework that governs clinical investigations for medical devices, which typically allows for prompt initiation following the necessary approvals.

For Class I devices, the regulatory pathway is generally less stringent compared to Class II or III devices, allowing for faster access to the market and quicker initiation of clinical trials. Once Ethics Committee approval is obtained, the investigation can commence without the long waiting periods required for higher-risk classifications. This rapid response reflects the lower risk profile associated with Class I devices, making it efficient to gather necessary clinical data.

The other options detail various conditions or time frames that are relevant to different classes of devices or scenarios and are not applicable to Class I devices under these specific circumstances.