Regulatory Affairs (RA) professionals are poised to play a key role in supporting the clinical or performance evaluation report (CER or PER) process. Regulatory Affairs is active throughout the entire process, from pre-project planning through scoping and kick-off, report writing, review and sign-off, and finally, submission to the notified body.
How Can Regulatory Affairs Assist in the Clinical and Performance Evaluation Report Process?
The CER and PER are highly complex reports—not just because of the large amount of data they contain, but because they must tell a complex story. Putting all the evidence together for a successful submission is a difficult task, but RA is strategically positioned to provide critically important support and guidance to the evaluation writing team.
Pre-Project Planning
Pre-project planning is the most critical time for active RA engagement. Key tasks during this phase include:
Perform a gap assessment, focusing ona critical review of clinical data sources and strategy around data sufficiency. Review the status of key documents to ensure final versions will be available to the writing team.
Establish a clear regulatory strategy, andinvolve internal stakeholders in early decisions and pre-planning activities.
Assess readiness and establish key resources. Ensure the writing team is prepped and trained. Assess the team’s capabilities, especially for conducting a systematic literature review, which is a documented, methodologically robust search and screening and selection of relevant published literature—this is not the same as an internet search.
Establish project timelines,allowing ample time for literature review, writing and cross-functional review/edits.
Project Scoping & Kick-off
Even though the writing team may be comprised of internal stakeholders, RA can ensure key tasks in this step are accomplished ed in a timely and efficient manner.
Identify the writing team, including the lead writer.
Review CER or PER input documents and ensure readiness of these documents.
Identify scoping questions to review at the project kick-off meeting, and develop a scoping checklist to guide the process and document key decisions. Scoping questions must be clarified at kick-off to ensure alignment between departments.
Schedule the formal kick-off meeting with the writing team, project management, clinical team, and RA.
Report Writing
The report-writing phase may seem outside the realm of RA, but it is the most active phase of the project and Regulatory Affairs support is often needed. RA team members are in the unique position to effectively communicate with every cross-functional project team member, giving them the distinct advantage over other members of the writing team, who may be more isolated within their own department. RA can be a real asset during slowdowns, especially when they:
Support the timely delivery of critical inputs from cross-functional departments. For example, the writing team may be awaiting Risk Management reports, and RA can step in to assist with communication.
Handle roadblocks that may occur, like stalled decision making, unresponsiveness from cross-functional stakeholders, or delayed documents.
Serve as a resource to the writers by finding answers to difficult questions and ensuring the team is getting information they need.
Support the project cadence and enforce the timeline.
Review & Sign-off
This phase of the project can often be delayed by unavailability of cross-functional personnel and external reviewers. RA can help the project stay on time in multiple ways:
Handle roadblocks like communicating with stakeholders who may be difficult to contact.
Plan for the cross-functional review of the CER or PER including blocking calendars of key stakeholders.
Enforce the submission timeline.
Submission
The writing is done and the report has been reviewed and approved by all internal stakeholders. In this phase, the Regulatory Affairs team gets to work to:
Gather all remaining approvals and final signatures
Prep the completed document dossier. And finally, forward the full submission packet to the notified body for their review and feedback.
The Road to Success
Regulatory Affairs can assist in the complex process of creating the CER or PER, from pre-launch planning to submission. Communication and planning skills position RA to aide in a timely and efficient report-writing process.
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.
[Free Webinar] IVDR Readiness: Creating a Blueprint to Build a Strong PER
Join us on Wednesday, June 7th, 2023 at 11 AM PST, as our regulatory experts discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report.
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
Are You Reg. Ready? Get your medical affairs team primed to manage new regulatory requirements
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
Driving Innovation to Success in the Market: Strategic Considerations
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
Privacy Overview
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
3rd Party Cookies
This website uses Google Tag Manager and Pardot's tracking features to collect information such as the number of visitors to the site, and the most popular pages. Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!