Any medical device manufacturer looking to introduce a new product to the European market, or to continue selling an existing product, cannot underestimate the importance of understanding, and correctly implementing, the requirements for clinical evaluation. Ultimately, adopting a pro-active approach to clinical evaluation reports (CERs) ensures manufacturers can reap business benefits to stay ahead in the market. Efstathios Vassiliadis, solutions delivery manager at Maetrics, explains
Any device which is sold into Europe must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File.
Whether or not a manufacturer wants to introduce a new medical device on the European market, or continue selling an existing one, they must not underestimate the importance of clinical evaluation to verify the device’s clinical safety and performance.
However, it has come to light that there is a significant lack of clarity available to manufacturers to help guide them through the CER process, which can result in varying approaches to tackling CERs by both the manufacturer and their Notified Bodies (NBs).
This can lead to CERs being potentially misfiled and manufacturers being unsure as to whether their CER process will be considered compliant and if their medical devices will have the appropriate documentation.
It has come to light that there is a significant lack of clarity available to manufacturers to help guide them through the CER process
Keeping CERs up to date not only enables businesses to keep selling their products, but means they will not have to deal with costly recalls and face the reputational damage which ensues; something which can’t be ignored given the speed at which information circulates today over social media platforms.
When the new MDR came into effect in 2017, a greater emphasis was put on the requirements defined by MEDDEV 2.7/1 Rev.4 , putting CERs under closer scrutiny as it called for the need for a better-documented process.
There has been a string of highly-publicised safety breaches putting NBs under increased pressure to improve their performance in terms of safeguarding public safety.
Since the implementation of the new MDR, and the arrival of the unannounced inspections by the NBs, manufacturers really can’t afford to let time be a hindering factor
However, a common challenge which many manufacturers come across is underestimating the time it takes to complete a CER. If all processes are followed in a methodical order then the average time for completion is about three months.
Since the implementation of the new MDR, and the arrival of the unannounced inspections by the NBs, manufacturers really can’t afford to let time be a hindering factor.
In order to help manufacturers, here at Maetrics, we have developed the following five key areas to help draft and maintain properly-documented, up-to-date CERs.
1. Employ a qualified CER writer
It is important for manufacturers to on-board qualified individuals who harbour the expertise to deal with clinical data.
Ideally, they will have detailed knowledge of research methodology and critical review skills; not to mention a general familiarity in regards to the CER process itself is fundamental to ensure no gaps are missed and to avoid non-compliance.
2. Develop internal procedures for the QMS
Developing an understanding of all the inputs to the clinical evaluation, particularly from internal sources (for example, product information, PMS and risk management data) and implementing associated procedures will ensure that the required information is available and can be obtained in the correct format and at the right time.
3. Execute proper training
Having properly-trained CER writers cannot be undervalued; this will save time as multiple revisions will not need to be conducted after being reviewed by the NB.
Therefore, ensuring this expertise is in house is essential.
It is a time-consuming process, but making sure there is enough dedicated staff working together can help avoid backlogs
There are training courses available on clinical evaluation and also for other aspects of research methodology if necessary.
4. Adopt a team approach mentality
Adopting a team approach will really help save time and effort.
For instance, data extraction requires a narrower skill set and can be done by someone other than the author of the CER.
In order to save time and improve overall quality it is important to look at individuals’ specific areas of expertise and utilise these. For example, a CER writer is required to collate data which might be more effectively produced by others within the team; for instance Equivalent Device data ideally should come from the technical team etc.
5. Adequate resourcing
It is a time-consuming process, but making sure there is enough dedicated staff working together can help avoid backlogs.
Many companies who need extra resource often look to insource or outsource the preparation of CERs (with many companies offering this service). The benefits of such an approach are that, with the right expertise and available larger teams, overall time frames can be diminished.
As the regulatory landscape evolves and more pressure mounts on NBs, it is critical that manufacturers prepare to increase scrutiny of their CERs, particularly due to heightened expectations with regard to the appropriate use of clinical data needed to support their devices.
By amalgamating the right knowledge and resource to tackle CER reporting, medical device manufacturers can reap business benefits to stay ahead in the market
Manufacturers cannot afford to delay and develop a comprehensive plan of action to meet the requirements of the changing regulations.
By amalgamating the right knowledge and resource to tackle CER reporting, medical device manufacturers can reap business benefits to stay ahead in the market.