The latest MDR (Reg 2017/745) from the European commission now requires an extensive research/review component.
If your firm has begun new CE marking procedures under this regulation, or are renewing products already at market, then you already are aware of just how time consuming and labor intensive the research based sections can be. A quick look at a breakdown of the components of a CE Marking Submission by time, and it becomes quite apparent that the largest (and most expensive) time consumer is the Literature Review Section.
The Importance of the Literature Review
The principal objective of the Literature Review is a ‘risk based audit’ of your product based on existing scientific literature. A well compiled Review will contain all current and relevant research, classify it properly and provide a written analysis/recommendation on the product’s current or anticipated safety results in the marketplace.
The manual review and tabulation of relevant Articles/Studies across multiple datasources is labor intensive and often monotonous. This costs your company:
- Internal hours of employee productivity
- Massively Increased Billings from External Writers
- Delayed Time to Notified Body Submission
Hiring Staff Writers
Even with an in-house staff or regulatory professionals and writers it may still be impossible to meet the looming compliance deadlines (May 2020) for all of your products. Taking into account the costs of complying with these additional regulatory burdens, some firms may determine that it no longer makes economical sense for some products to be marked and sold in the Eurozone all together.
Third Party Writers
Due to these concerns, many manufacturers are left no option other than to leverage third party writers to prepare their full submission paperwork. This can be a great solution, however with external service providers costs are often undefined and project lengths left ambiguous. For firms with limited budget and timelines, a more concise and economical solution is required.
Our Team’s Experience
CiteMed is a Regulatory Focused Company with a culture of innovation. Our staff of seasoned regulatory writers work with our technical team to deliver the absolute best in MDR compliant Literature Reviews and product risk assessments.
Our proprietary system uses technology to deliver a research driven risk assessment resulting in an impressive error free deliverable to clients at a fixed cost and firm deadline.