Your trusted CER partner

A8. Devices for unmet medical needs – aspects to consider

Like all medical devices, medical devices for unmet medical needs must fully comply with the Essential Requirements in order to be CE-marked. The evaluators should assess whether devices deliver clinical benefits to patients for

• medical conditions that are life threatening, or cause permanent impairment of a body function, and
• for which current medical alternatives are insufficient or carry significant risks.

Corresponding devices are referred to as “breakthrough products” in this Appendix.

1. Breakthrough products
   In exceptional cases, major benefits may justify relatively high levels of uncertainty, and access to the market may be granted on the basis of limited clinical evidence such as

• experience available from compassionate use/ humanitarian exemption programs, use of custom-made devices, results of feasibility studies;
• limited long-term data.

In addition to general aspects described in this MEDDEV document, the evaluators should fully disclose the situation and address the following items in the clinical evaluation report:

• the exact intended purpose, including the medical indication (if applicable to the device), the product was developed for and whether residual risks and uncertainties or unanswered questions are considered acceptable in this indication (often a niche indication);
• explanations of why current medical alternatives are considered to be insufficient or to carry significant risks;
• explanations of the benefits delivered by the device under evaluation;
• whether the IFU clearly describe
  • the exact intended purpose (including medical indications) and any limitations,
  • the limited clinical experience,
  • uncertainties or unanswered questions about residual risks and benefits to patients19;
• the need to set up a stringent PMCF plan with information on
  • the type and quality of data that needs to be generated in the post-market phase in order to further evaluate the clinical performance and clinical safety of the device;
  • how to generate data in a timely manner and aspects thereof, including projections on the numbers of patients that will be managed with the device per year;
  • in the following cases, the manufacturer should aim at including all patients in PMCF studies:
    • a device that carries significant risks (i.e. expected to cause serious adverse events), or
    • a device for rare diseases.
  • the need to actively update the clinical evaluation report when new significant information become available, and in accordance with Section 6.2.3 b of the present document.
• In these exceptional cases, notified bodies should perform annual assessments of the updated clinical evaluation reports and the results of PMCF studies.
• Subsequent products
  Devices that enter the market subsequent to a therapeutic/ diagnostic breakthrough can not be judged by the same criteria as listed above for breakthrough devices. When performing a clinical evaluation for these devices, the following considerations should be taken into account:

• when a device enters the market subsequent to a therapeutic/diagnostic breakthrough, clinical evidence is likely to have evolved rapidly since the first breakthrough device became available
• with the evolving body of evidence, entering the market with large uncertainty may no longer be legitimate
• if PMCF data are required, PMCF Studies should also be foreseen for devices that enter the market subsequent to a therapeutic/ therapeutic breakthrough