Challenges involved in clinical evaluations
The Challenges now faced for clinical evaluation.
Now that the new European medical device regulation or better known as (MDR) has come into place, the focus on clinical evaluation is the key ingredient to a successful result of producing a safe and compliant device in the market. Clinical evaluation is assessed through the process that an organisation/manufacture has covered over the entire product life cycle and requires a strong working relationship with risk management processes that carefully aligns this process. To consider an appropriate way to establish an end of a product life cycle, this can be phased out with the end of the documentation storage as defined in the MDR annexes. The safety and efficiency, including the benefits of evaluating the device when used as intended by the legal manufacture, are verified. It is of paramount importance that the intended use or purpose of the device starts at the beginning of the process journey.
The most critical task when preparing clinical evaluation is the risk classification associated. These are defined from (low>High risk: I, IIa, IIb and III) higher risk classification, such as IIb and class III was always under more scrutiny compared to lower classification primarily down to the device as this would be recognised as a life saving medical device such as implantable devices (class III) require mandatory clinical investigations unless existing clinical data is justified with an acceptable level of risk management considered. For example, products defined as stand-alone software can generally fall under the IIa classification. However, depending on the therapy’s side effects, this could now fall under the classification of IIb or higher. Since class one can avoid notified body assessments, while anything higher is mandatory, the clinical evaluation and assessment of many products will be externally evaluated and carried out in the future.
Consider all aspects when gathering information from resources that provide a literature research when it comes to clinical evaluation, make sure the databases are recognised and trusted resources. The positive outcome of this research must consider the negative results and should be ensured objectively. The clinical evaluation is becoming more complex and now focuses on more documents to be used when gathering information on the device’s performance in the market, some manufacturers will already have a post market surveillance process, this will collect the data required to establish how the device is performing in the market, while keeping a close eye on you competitors.
Clinical Evaluation Reporting:
Some of the documents to be considered when designing the clinical evaluation process associated with the MDR.
- Clinical evaluation plan.
- Clinical evaluation Report.
- Post-market surveillance plan: Looking to the market to collect and analyse relating to experiences to manage post-market activities.
- Post Market Clinical follow the plan: Or if it is not required, a justification is warranted.
- PMS report that summaries’ the results and provide conclusions for class I post-market surveillance data.
- Periodic safety update report for Class IIa, IIb, III devices.
- Clinical Evaluation Assessment Report: This report will be complied with by the notified body. The report will document the evaluation’s conclusions, which had been in place prior to the MDR Introduction. Still, the information pertaining this investigation will become more public, especially when discussing high-risk devices. Therefore, the notified body will document the results and share this information from the Clinical Evaluation Assessment Report, where an expert panel, the competent authorities, the authority responsible for notified bodies, and the EU Commission will have access.
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- Main Blog
- What is a Clinical Evaluation?
- Factors to keep in mind preparing for Clinical Evaluation.
- Steps by Step guide for Clinical Evaluation reporting – Medical Devices in the European Union