Why Do So Many Firms Want to Get The Assistance From CER Consultants?

 

A well-designed and written clinical evaluation report (CER) is essential for manufacturers of both new and existing medical devices because clinical evaluation is a crucial part of the technical documentation needed for regulatory compliance of medical devices sold in the European Union (EU). This is especially true now that the Medical Device Regulation 2017/745 (MDR) has been passed. The MDR directive imposes stricter regulations on the safety and performance of medical devices. 

Not only are new devices seeking regulatory compliance impacted, but devices that were on the market before the implementation of the MDR directive are also impacted, as each device must be resubmitted for CE certification before the transitional period is over. To be in regulatory compliance, manufacturers will need to update the CER for each device to current MDR standards. According to a survey of medical device manufacturers, 78% do not understand MDR sufficiently, and 58% do not have a strategy in place to correct gaps in their clinical data or a process in place to collect the data required (KPMG & RAPS). If there is so little time left to meet the MDR transition deadline, consider hiring a CER Consultant to assist you.

Why Is The CER Important For European Union Marketing?

The CER documents the entire clinical evaluation process of a device and is required for regulatory compliance for marketing in the EU. The CER essentially outlines the assessment and clinical data that determine whether evidence sufficiently verifies the clinical safety and performance of the medical device. 

The Manufacturers need to have experienced CER writers who can integrate complex regulatory requirements with the device's unique characteristics and present the information. As a result, it can save both time and money. Putting together the CER document necessitates a thorough understanding of the regulations' meaning as well as the ability to apply the MDR regulations to the specific situation of each device.

The Clinical Evaluation's Central Theme Is "State of the Art." 

Establishing and describing the state of the art for each medical device is critical to the clinical evaluation because it provides a reference standard for determining whether the device's safety and performance are compatible with current treatment options. This information is documented in the CER and used throughout the clinical evaluation process. 

Why You Should Be Choosing Us?

Our clients appreciate the transparency with which we provide our services at Thomas Regulatory Resolutions (TRR), which includes a perfect time frame for delivering the CER as well as detailed information on compliance gaps. Our writers have all written CERs before and are up to date on current regulations. We distinguish ourselves from other companies by providing a comprehensive analysis and subsequent solutions. Please contact us if you'd like to discuss how we can assist you with your CER writing and regulatory needs. We also have the best FDA COVID-19 Coronavirus SARS-COV-2 Consultant if you want your medical products to be safe during the pandemic crisis.

Source.

What Everybody Needs to Know about Clinical Evaluation Reports?