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 on a 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, and involve 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.