Author: Criterion Edge Writers
Regulatory advertising and promotion (A&P) professionals bring a unique set of skills to their role. While they typically work within a multidisciplinary group of medical, legal, and commercial experts who review device promotional content, A&P professionals have considerable knowledge of European Union (EU) and Food and Drug Administration (FDA) regulations that can additionally benefit product development in areas outside of the promotional review process.
MDR and IVDR Updates: What Do They Mean for Manufacturers?
There are a number of important areas where organizations may benefit from early incorporation of A&P into the product life cycle. This is especially true for the necessary updates of processes and procedures to meet the new standards required by the Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) directives in the EU.
Both MDR and IVDR directives contain stricter regulations on safety and performance than previous standards, and both new and existing devices are subject to these new regulations. This translates to an industrywide updating of the clinical evaluation report (CER) and performance evaluation report (PER) development processes for companies to maintain regulatory compliance.
Regulatory A&P professionals, who are familiar and facile with complicated issues around regulatory compliance, are an underutilized resource in this area. Ensuring compliance of promotional communication with applicable laws and regulations is in the standard purview of A&P professionals, and these skills translate readily to involvement in the preparation of CER and PER documents.
How Can A&P Professionals Become Involved in the Clinical Evaluation Process?
While the commercial and regulatory success of a device is always impacted by regulatory A&P professionals, earlier-than-usual involvement in the development lifecycle may impart greater success.
Early inclusion of A&P can positively influence critical decisions in product development. For example, an identified concern for the sufficiency of device data may lead to recognition of a need to conduct further research that otherwise may not have occurred until much later in the process. Alternatively, there may be a shift to modify device design to ensure an equivalency argument to a predicate device.
Link Between R&D and Commercial Departments
Another aspect of possible added value that A&P professionals bring to a company is that of a link between the research and development (R&D) and commercial departments. With their unique skillset, which includes deep knowledge of FDA and EU regulations and commercial principles, they can be a natural fit to fill potential gaps between these departments.
Target Product Profiles
Target product profiles (TPPs) are a planning tool used to identify desired device attributes and organize commercial strategies. A&P can be instrumental in the development of these profiles, which assist companies in highlighting the path from R&D to commercialization to regulatory approval.
TPPs can also shape future data-gathering opportunities, like clinical studies, registry participation, and ongoing post-market clinical follow-up activities. Regulatory A&P professionals, who are able to analyze the data behind product claims for appropriateness and statistical soundness, can add value and reduce inefficiency when involved early in this process.
Product Labeling Strategy
A company’s product labeling strategy is yet another area where A&P professionals may exert influence.
A pivotal element of the clinical or performance evaluation process, product labeling, is a task that serves to inform patients and clinicians and promote commercial viability. Given their knowledge of the labeling requirements of regulatory bodies like the FDA and EU, regulatory A&P can offer an important perspective early in the process to ensure the creation of labeling that is both compliant and impactful.
Although regulatory A&P professionals are often exclusively involved in the promotional review process, there are multiple ways they can bring additional value to an organization.
A successful and compliant clinical or performance evaluation process relies on strong cross-discipline partnerships within organizations, including with A&P. Early engagement and ongoing interactions are key to commercial and regulatory success.
Does your organization need support for MDR related submissions including CER, CEP, PMCF plans or reports? Or IVDR related submissions like PER, PEP, SVR, CPR, or PMPF plans or reports? Criterion Edge has the expertise and bandwidth to work with you and get the job done. We have expert medical writers to support your organizations in developing the necessary documents to ensure a smooth transition and meet these fast-moving deadlines. Get a free consultation today.