The In Vitro Diagnostic Medical Device Regulations for Medical Devices/Medical Devices had been published in the Official Journal of the European Union, May 5, 2017. This was after years of development. These regulations replace the Directives that were previously applicable to the European market. They will be implemented in the coming years. We’ll focus on the one aspect of market approval MDR emphasizes, which is more robust clinical evaluation processes.
1) What is clinical evaluation?
Clinical evaluation is a methodologically sound process to gather, appraise and analyze clinical data related to medical devices. Clinical evaluation includes the analysis of whether there is enough clinical evidence to support compliance with the relevant requirements for safety and performance while using the device according to the manufacturer's instructions.
2) What sources are used for clinical evaluation?
For clinical evaluation, sources can include published data on a similar device, clinical investigations data, post-marketing surveillance data, public adverse event databases (e.g. FDA's MAUDE for equivalent devices), and internal corrective or preventive actions.
MDR has made it a requirement that all patients submit a formal Clinical Evaluation Report (CER). CER could be the most crucial tool to provide safety and performance data. This requirement could also be a trigger to implement an operationalized approach to device development projects that had previously been lacking structure.
3) What is the purpose of clinical evaluation?
To be eligible for CE marking, which is required for medical devices sold in the European Economic Area, must have been evaluated clinically. The EEA, which includes all EU member states, Iceland, Liechtenstein and Norway, Switzerland, Turkey, is a major market.
A CER must be included in the CE technical files as part of the CE marking/conformity evaluation process. In addition, Premier, a clinical research organization, often provides CER-related services such as document preparation.
4) What effect does MDR change on clinical evaluation?
Although the impact of changing from Directives to Regulations is complex, clinical evaluation is crucial for planning three important processes.
· The Scrutiny Process
Under the new scrutiny process, authorities may decide to re-examine technical documentation before CE approval of high-risk devices. In addition, article 44 requires that notified bodies submit new technical reviews reports. This could have an impact on submission timelines.
· Reclassification
MDR may require products to alter their classification. This is largely based upon clinical evaluation data. Products are currently classified according to their risk. This system allows medical devices to be classified according to their risk. For example, in vitro diagnostic devices classified as General (no notified bodies’ approval required) could be reclassified as Annex II List A. This will require both notified bodies approval and additional audits and reviews. All devices except Class A will need to be evaluated by the notified bodies. This includes in vitro fertilization diagnostics and spinal devices.
· Comparative Evaluations
MDR also imposes more stringent requirements for comparative assessments. To demonstrate product safety or performance will take more effort. Manufacturers and their representatives will have to produce more data and interpret it with greater precision. To present these evaluations, manufacturers of comparison devices will need to approve.
5) When should a clinical evaluation be performed?
The clinical evaluation process continues throughout the entire life cycle of a medical device. This includes the design phase when an operational team should join in planning and strategizing.
CERs are the most important form of CE marking. However, clinical evaluation is crucial. CERs can then be updated with clinical evaluation data at one or more time points.
Every year, for high-risk or innovative devices, for established devices that is not likely to pose significant risks, every 2-5 years. As more clinical data become available Product design and intended use may be modified.
Manufacturers should justify the frequency of CER updates. When planning the timeline, it is important to consider relevant factors such as design changes, scientific developments, risks, and risks.
6) What should be the procedure for clinical evaluation?
It may seem appealing, but a wait-and-see approach is not the best way to go during this transitional period. Instead, manufacturers and clinical researchers organizations (CROs) need to take proactive steps to ensure that all data is available for future CERs.
The clinical evaluation process is cyclical. It consists of five main stages.
Stage 0: Plan, transition strategy, and gap analysis -- The most crucial step from an operational perspective Stage 1: Identification and collection of relevant data Stage 2: Collecting and analyzing clinical data -- this is where clinical trials start Stage 3: CER preparation and post-marketing surveillance/post-market clinical follow-up plans -- clinical evaluation is synthesized into one document and continues with post-market data Stage 4: Periodic updates -- The CER is updated as needed
This is when the manufacturer wishes to make significant changes to a product or market a similar product to one already in production.
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