The MDR requires manufacturers to stay continually invested in the product life cycle, updating data regularly to avoid bottlenecks in the pathway to draft a CER. Efficient manufacturers approach the process during the research phase and will document aspects relevant to the clinical evaluation from both internal and external sources.
One of the first steps is to perform a EU MDR gap analysis on your existing CERs and identify the missing items per the updated regulations. Key questions for manufacturers include – what are the weaknesses of the current CER and the Technical documentation in place? How is the process of developing and updating the CER uncompliant to the regulations? And what new requirements are to be implemented to ensure a systematic approach towards regulatory compliance?
With a clear understanding of how to approach these aspects, manufacturers must proceed towards answering those questions by including the right information sources into the CER – typically including risks, PMS data, clinical study data, and product information. Manufacturers can set up a standard operating procedure to update all internal technical files with standard templates across the board ensuring comprehensive data to be captured every review cycle. This helps equip companies to consistently follow the systems that are in place, which ultimately will save time in the next review cycle.
Additionally, qualified clinical evaluators are a mandated requirement under the MDR. With stricter standards for medical device equivalency, risk/benefit justifications, and scientific validity of data, poorly authored/organized CERs can slow down the compliance process, delaying the CE marking. Some of the key factors in choosing the clinical authors/evaluators includes an advanced degree, medical writing and/or documentation experience, knowledge of the therapeutic area, regulatory requirement knowledge, and clinical/research methodology.
Developing a clear approach to authoring a CER will help manufacturers withstand the heightened level of scrutiny demanded by the current regulations from the Notified Bodies. Setting up strategies for elements like SOPs for completing technical file documentation, well-functioning QMS systems, and obtaining qualified personnel to author comprehensive CERs is imperative. While it might initially seem like a daunting and lengthy process, it will only help the manufacturers in the long run.