Clinical Evaluation V/S Investigation
As mentioned previously in our blog and EU MDR, a Clinical Evaluation “means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer”.
A clinical investigation is a clinical trial (study) in at least one human subject, which is undertaken to assess the performance, and most importantly, the safety of a specific medical device. MDR Article 2(45) defines ‘clinical investigation’ as any systematic investigation involving one or more human subjects to assess a device’s safety or performance. When clinical investigations are conducted under MDR, they will also need to comply with any applicable common specifications defined in Article 2(71) in addition to requirements in Articles 62-80.
The first instances of Clinical Investigations started in 1990, which involved all active implantable medical devices. Since then, regulators have widened the scope and as per EU MDR 2017.745, Article 61(4), clinical investigations are now required for approvals of implantable devices and class III medical devices.
Are there any exceptions for Class III Medical Devices?
Well, yes, the following categories are exempted from a clinical evaluation:
- The device has been designed by modifications of a device already marketed by the same manufacturer,
- The manufacturer has demonstrated the modified device to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV, and the notified body has endorsed this demonstration, and
- The clinical evaluation of the marketed device is sufficient to demonstrate the conformity of the modified device with the relevant safety and performance requirements.
In these cases, the notified bodies shall check the details on a PMCF plan, including post-market studies. This is important as the documents will demonstrate or confirm the safety and performance of the device.
Navigating the need for clinical evaluations and Clinical Investigation is a tricky process. Attempting to navigate this yourself, may help prevent regulatory pushback but equally, it can lead to a waste of resources and delay time to market. Why risk the marketability of your innovations?
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