Guidance to Master New Clinical Evaluation Report

Sophiya Williams

To obtain approval for regulatory compliance and sales in Europe, all medical devices must be accompanied by a Clinical Evaluation Report (CER) that documents the complete clinical evaluation process. This is not an original obligation for manufacturers of devices. However, with the recent scandals relating to medical devices posing doubt on the validity of existing requirements, it was necessary to introduce a newly-introduced Medical Device Regulation (MDR) that was announced in May 2017 has increased the standards for CERs. 

Although we are more than one year into the transitional period for the MDR, there remains confusion regarding the requirements. Because each medical device has to be registered for a brand new CE mark. The lack of clarity is troubling for manufacturers since it hinders obtaining compliance. 

Manufacturers must provide CERs that are appropriately documented at the time of inspections. Or they could be subject to having their products have taken off the market, which could be a devastating outcome for their business and possibly for healthcare professionals and patients who require specific devices. Instead of taking a wait and see' strategy, companies must begin to review their current CERs as soon as possible.

Existing guidelines to write reports on the clinical evaluation of medical devices 

In the beginning, manufacturers must follow instructions regarding the CER approach published by the paper MEDDEV 2.7/1 Version 4. The document is in its fourth edition and is the most stringent standard for CERs.

Finding the correct information for reports on clinical evaluation

To prepare reports, manufacturers must know whether they have the correct data available. Manufacturers should be able to prove:

• that the device performs as per the intended performance

• That the identified and predicted dangers, as well as any harmful incidents, are minimized and are acceptable concerning the advantages of the intended use

• Any assertions made about the device's performance and security is backed by sufficient evidence.

 For available devices, manufacturers must be conducting regular post-market surveillance to collect data about the actual use of their devices. This will reveal any risks or complications that are not anticipated and areas to improve. If they've been unable to conduct this surveillance and are not doing so, they must start the lengthy and expensive collating the data.

When it comes to new products, businesses cannot depend on information from similar devices made by other companies. The MDR requirements are stricter, and the required information can only be obtained internally. This will mean an increase in clinical trials, and businesses that delay their practices will struggle to find the experienced staff and resources they require. The best-practice CERs can take anywhere from three months to complete in the event of insufficient information, help or expertise and expertise. The anticipated timeframe could be considerably longer.

Standardize processes to avoid stress

If they don't, companies should consider CERs as a regular activity throughout the lifecycle of a product and device. Efficient processes throughout the organization to ensure that all the data required for reports is available at all times; that includes all product information and post-market surveillance and risk management information.

When you need to write reports, businesses can improve the efficiency of the process by establishing a Standard Operating Procedure (SOP) that allows staff to adhere to the proper procedure using standard templates. However, reports require the input of qualified professionals. The current guidelines can appear unclear in certain instances. Moreover, should companies create reports according to their interpretation of the regulation; they could be subject to having reports returned. The expense for the training of clinical evaluation professionals and other related processes could be significantly smaller than fixing CERs in the aftermath of the NB review. 

Finding a specialist writer is essential.

A portion of the knowledge required for CERs could already be available internally, and manufacturers shouldn't be afraid to delegate tasks to the appropriate teams within the business. Quality and regulatory compliance activities are not limited to a single individual or group within a business due to their importance. The overall performance of the CER will be improved when a variety of skill sets are utilized and lets the regulatory personnel focus on other responsibilities in addition. Companies that don't have the required internal skills may seek external service providers to fill in the gaps and offer expert advice.

Looking ahead

The magnitude of the newly enacted Medical Device Regulation means that many manufacturers face the enormous task of reviewing the documentation for their entire portfolio of products. According to a report from a few years ago, 58 % of companies that manufacture medical devices claim that they have no plan that can be implemented to fix the gaps in their clinical information or procedures for collecting information. CERs are a crucial element of compliance and an element that is the most difficult with the newly-enacted MDR, which is why companies must follow the steps above to develop an enlightened, comprehensive plan to ensure long-term CER success. 

Medical devices need CE certification before being sold within the European Union. CE marking signifies that the product has been evaluated and has all the safety and health standards set in the EU. When submitting devices for the CE marking, companies have to supply technical documentation, including the Clinical Evaluation Report.