Trends in Clinical Trials for Medical Device

Trends in Clinical Trials for Medical Device

Unlike the situation for new drugs, it is not necessary to conduct clinical trials for every new medical device before it is approved and marketed. This depends on the device classification. Although each country or region defines the device classification in somewhat different ways, they each include an evaluation of risk. Generally, a medical device is classified according to following categories:

  • Class 1: Non-invasive/low risk device (e.g. elastic bandage, medical thermometer )
  • Class 2: Medium risk device (e.g. insulin pen/pump, IV container)
  • Class 3: High risk device (e.g. coronary stent, cardiac pacemakers)

 

All medical devices marketed in the EU regardless of classification must have a clinical evaluation on file with the regulatory authorities. In recent years, more requirements apply to medical device development including the need of data from clinical trials. Below are some trends observed in the clinical development of a medical device.

Trend 1: Reduced acceptance of clinical literature only

In general, request for prospective data from clinical trials has been increased in order to support CE mark. The standard has also been changed from “similar” to “equivalence”. Equivalence is defined as same indication for use, same technology and same biological characteristics. If the two medical devices are not equivalent, prospective data are needed for filling the gap.

Trend 2: Increased scrutiny over sample size selection

The authorities demand a greater pre-marked assurance for safety of a medical device. Therefore more safety data and prospective  data from clinical trials are needed before the device can be marketed. Authorities and and ethics committees prefer limited no. of patients participated in clinical trials with investigational medical device if possible. Therefore the company needs to prove a sound basis for appropriate sample size and statistical hypothesis as applicable.

Trend 3: Impacts on clinical trials approval

The company needs to finalize the gaps before applying for clinical trial approval, e.g.:

  • Risk assessment
  • Pre-clinical animal studies
  • Biocompatibility
  • Sterilization validations
  • Other requirements

The EU based clinical trials will probably occur later in the device development cycle in order to have enough data for submission to the authority. However, approval of clinical trials within the EU becomes more consistent because local laws have been aligned with the Medical Device Directive.

Trend 4: Increased requests for post market studies

The requirement for post market studies has been increased as part of post market surveillance plan, which can be part of the submission. I.e. the company can have a small clinical trial, but a large post market study.  This depends on the device type, similarity to current marketed device, or new device etc.

In addition, much more scrutiny of the post market surveillance plan including review of data collected is expected from the Notified Bodies and Authorities.

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PharmaGCP specializes in GCP/ISO14155 training and audit of clinical trials with investigational medical device. Our specialists have many years’ experience in clinical quality area such as GCP inspector, auditor, clinical quality assurance manager.

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