MEDDEV 2.7.1: clinical evaluation
New Regulation on Clinical Evaluation
One of the changes of the Medical Device Regulation by the European Commission is the compliance with clinical evaluation. This means that a report with an expert opinion of medical professionals about the quality and safety of the medical device will not be sufficient any longer. This new regulation is believed to be one that manufacturers are struggling with. Such requirements were already prepared by the MEDDEV 2.7.1 Rev.4 (clinical evaluation MEDDEV) which content has then been captured in the European Medical Device Regulation 2017/745 MDR.
What is clinical evaluation?
Clinical evaluation is an ongoing process to collect and analyze clinical data regarding the medical device and to determine whether the clinical evidence comply with the essential requirements for the safety and performance according to the manufacturer’s intended use. This requirement applies to all classes of medical devices and the evaluation must be appropriate to the device, it’s specific properties and intended purpose. With this evaluation, benefits and risks must also be specified. This process is the responsibility of the manufacturer and applicable to the manufacturer’s own medical device, not an equivalent device.
Clinical evaluation is also a requirement for the conformity assessment process that will lead to CE-marking and placing of the medical device on the market. It should follow a very structured format with different stages as described in the MEDDEV 2.7.1.
When is clinical evaluation done?
Since clinical evaluation is a mandatory ongoing process for medical devices, it is then conducted throughout the medical device’s life cycle and must be actively updated afterwards. It is usually started during the development of the medical device to identify data needed to be generated for market access.
Clinical evaluation is an important process because it ensures that the safety and performance of a medical device is based on clinical evidence all through the life cycle of the device while on the market. The ongoing process of clinical evaluation also ensures that manufacturers will be able to provide enough clinical evidence to notified bodies and competent authorities, which will show conformity of the medical device with the requirements throughout its life cycle.
How is clinical evaluation performed as per MEDDEV 2.7.1 ?
Clinical evaluation is based on the analysis of pre- and post-market clinical data relevant to the medical device’s intended use; this also includes clinical performance and clinical safety data. There are stages on how to perform clinical evaluation and they are as follows:
Stage 0 – the stage where the scope and plan for clinical evaluation is defined.
Stage 1 – the stage where pertinent data are identified.
Stage 2 – the stage where individual data sets are assessed based on scientific validity, relevance and weighting
Stage 3 – the stage where data are analyzed and conclusions about compliance, information materials and uncertainties are reached.
Stage 4 – the stage where clinical evaluation report is finalized.
The clinical evaluation report with relevant clinical data will comprise of clinical evidence that will aid in assessment of the medical device’s conformity.
Who should perform clinical evaluation?
While it is the manufacturer’s responsibility, clinical evaluation must be conducted by qualified individual or team. Manufacturers must consider the following:
- Define requirements in line with the nature of the medical device including clinical performance and risks
- Be able to Justify the choice of evaluators in reference to qualifications and experience
- Evaluators must have knowledge on
- Research methodology
- Information management
- Regulatory requirements
- Medical writing
- Evaluators must also have knowledge on
- Technology and application of the medical device
- Diagnosis and condition management to which the medical is intended for
- Medical alternatives, treatment and technology
- Evaluators must possess relevant training and experience with a degree of higher education in the field, 5 years of documented professional experience or a 10 year documented professional experience if degree is not a prerequisite for a task
- Evaluators must have knowledge on
More information on MEDDEV 2.7.1 is on the Europa website.
The above will be required for the Europe medical device registration.