Implantable Medical Devices and Class III Devices

In the case of implantable medical devices and Class III devices, clinical trials are conducted, except in the following circumstances:

• The device is designed through modifications of a device already placed on the market by the same manufacturer;
• The manufacturer has demonstrated, in accordance with Annex 3, that the modified device is equivalent to the device already placed on the market, and this demonstration has been found satisfactory by a Notified Body; and
• The clinical evaluation of the device placed on the market is sufficient to demonstrate that the modified device complies with the relevant safety and performance requirements.

In such cases, the Notified Body ensures that the Post-Market Clinical Follow-up (PMCF) plan is appropriate and includes post-market studies to demonstrate the safety and performance of the device.

However, there is no need to conduct clinical trials in the circumstances referred to in paragraph 6:

a) A device that has been legally placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC, and whose clinical evaluation is:

• Based on sufficient clinical data; and
• In accordance with the applicable specific product common specifications (OS) for the clinical evaluation of such medical devices, if available, or

b) Devices like sutures (surgical threads), staples, dental fillings, dental brackets, dental crowns, screws, wedges, plates, wires, pins, clips, and connectors, whose clinical evaluation is based on sufficient clinical data and complies with the applicable product-specific common specifications (OS) if available.

In addition to the requirements outlined in paragraph 4, a Medical Device Manufacturer who demonstrates that its device is equivalent to a device already placed on the market and not manufactured by itself may rely on paragraph 4 as the basis for not conducting a clinical trial, provided the following conditions are met:

• The two manufacturers have a valid contract allowing continuous access to the full technical documentation of the second device’s manufacturer; and
• The original clinical evaluation has been carried out in compliance with the requirements of this Regulation.

The manufacturer of the second device must provide clear evidence to the Notified Body regarding these conditions.