Clinical evaluation of eyeglasses

Regulatory framework

Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745. On the other hand, sunglasses are considered personal equipment. All devices, regardless of their risk class, require a clinical evaluation as part of their technical documentation. Meaning that manufacturers shall plan, conduct and document a clinical evaluation in accordance with Article 61 and Part A of Annex XIV of the Regulation (EU) 2017/745.

Particular attention on the regulatory requirements should be given by manufacturers that they have marketed their medical devices under the MDD using the OEM/PLM construct.

For more information, please refer to our blog article:

qtec Blogbeitrag Fehler in der MDR "AUS" für die OEM?| qtec-group

Ist die MDR wirklich das „AUS“ für die OEM?

Clinical evaluation process

Eyeglasses are typically considered as a well-established technology (WET) (see MDCG 2020-6). The common features of such devices are the following:

relatively simple, common and stable designs with little evolution
their generic device group has well-known safety and has not been associated with safety issues in the past,
well-known clinical performance characteristics and their generic device group are standard of care devices where there is little evolution in indications and the state of the art,
a long history on the market.

Typically, no clinical investigations or PMCF studies are required since such products are based on well-established technologies, with little or no innovation and a long market history. Their compliance to the General Safety and Performance Requirements (GSPR) may be proven by pre-clinical and proactively collected Post-Market Surveillance (PMS) data. In addition, the manufacturers must perform a literature search, including both state-of-the-art as well as similar devices.

The state-of-the-art literature review is conducted with regard to the general state of the art, clinical background, alternative and current technologies including related safety and performance issues.

The similar devices are investigated with regard to the potential safety and performance issues and to confirm the parameters, which are used in determining the acceptability of the benefit-risk ratio for the intended purpose of the devices under evaluation.

The first step for the clinical evaluation is planning its conduct. The relevant data must be identified and subsequently appraised. The next step is the analysis of the clinical data and ultimately the writing of the Clinical Evaluation Report (CER). An overview of the clinical evaluation process is shown in the figures below.

qtec group | Clinical evaluation process figures| qtec-group

Pre-clinical data include the test results in various areas, such as biocompatibility, biomechanics, animal testing, etc. The lower the risk class of the medical device, the greater the amount of pre-clinical evidence that should be shown.
Clinical data may include data from the scientific literature as well as PMS data.

Common challenges in the clinical evaluation of eyeglasses

The most common challenge is the planning of the clinical evaluation in a timely manner. Since the CER is the last document of the technical documentation which is written, this means that all other documents should be made available beforehand. Consequently, all pre-clinical testing and proactive collection of PMS data should be complete before starting writing the CER.

Manufacturers should exhaustively test their devices to prove their compliance with the (harmonized) standards and common specifications, when applicable. Furthermore, the proactive collection of PMS data should be implemented in a timely manner and the technical documentation should be compiled.

A lack of (own) clinical data for eyeglasses is often problematic for their transition to the MDR. However, since many of these devices have been on the market in almost unchanged form for a very long time, the data from market experience can support the well-established technology approach.

qtec expertise

qtec could help you with the following:

End-to-end writing of Clinical Evaluation Report, including Clinical Evaluation Plan and literature search.
Developing the clinical evaluation strategy for your organization.
Develop a Clinical Evaluation Report template for your organization.
Gap Analysis for existing Clinical Evaluation Report.
Develop a standard operating procedure for your team to compile clinical data as well as update Clinical Evaluation Reports.
Updating of existing Clinical Evaluation Report.