Since the 2021 updates to European medical device regulatory submission guidelines, ÂÂit’s become more important than ever for cross-functional teams to tightly coordinate their efforts to comply with regulatory requirements.
To this end, teams should start preparing regulatory documentation as early as possible to help ensure a successful European Union Medical Device RegÂÂÂulation (EU MDR) submission. All teams involved must also be on the same page with the claims being made and have access to the same supporting literature, housed in a centralized place to avoid duplicate work and for ease of retrieval.
While coordinating efforts around EU MDR submissions can seem daunting, there is a software solution that can help streamline this process: RightFind Enterprise from CCC.
Make EU MDR Submission Easier with RightFind
Thanks to its content access and reference management capabilities, RightFind Enterprise can help teams within medical device organizations work together to avoid duplicate and unnecessary work. RightFind provides the ability to create centralized libraries to house product documentation, along with tagging for easy organization of supporting documents within those libraries. Saved citations can then be retrieved easily through RightFind from within Microsoft Word or PowerPoint with RightFind Cite It.
As teams prepare to submit to notified bodies, access to supporting literature and centralized libraries through RightFind can help them as they compile their clinical evaluation reports, risk management documents, design history files, and other supporting documentation needed to meet the updated safety and performance requirements of EU MDR.
Supporting Product Literature and Centralizing Documents
A previously approved product may once have had supporting literature that is not stored in a central location, especially if it hasn’t been needed for several years. With RightFind, archived literature can be requested and provided in a digital format to support new regulatory submissions for existing products.
This feature is especially beneficial in instances where old copies can’t be located or aren’t in the appropriate digital format. There are over 165 million citations in the RightFind catalog, and content not in that catalog can still be requested through the CCC ‘ends of the Earth’ service to locate hard to find literature, so it’s easy to retrieve any literature needed to support a successful EU MDR submission.
As teams prepare their submission with new requirements for QMS, Clinical Evidence, and Clinical Documentation, they need to be aligned on claims being made and work together to tell the story of the device’s safety and efficacy. Weaving a story to tell to notified bodies requires a unified approach without silos, and having centralized literature for all teams to access keeps everyone in the loop.
The RightFind libraries serve as centralized spaces where references and full text articles can be stored and made accessible to everyone involved. The built-in ability to quickly and easily verify reuse permissions means that regulatory teams can check documents for coverage under existing licenses and agreements and that they can acquire transactional permissions for submissions if needed.
RightFind’s Shared Libraries can also serve as dedicated libraries for each device in a company’s portfolio with access granted to every team involved in that product’s lifecycle. This way, all literature associated with that device can be centralized in that library as teams compile the necessary documents needed for an EU MDR submission.
Further, the use of tags allows the content to be organized within the libraries. For example, a tag could be associated to all literature needed for a clinical evaluation report for ease of organization and retrieval. Tags could also be assigned for each type of use of a product, or each part of a product.
EU MDR is much more stringent than its predecessor, the Medical Devices Directive (MDD), and complying with the new requirements requires a coordinated, unified approach to accessing and organizing supporting literature. RightFind helps with access to copyright compliant content along with organization of literature to support detailing safety, oversight, and risk management.
Simplified Citation Management
RightFind Cite It, a simplified reference management module, integrates seamlessly with RightFind Enterprise and lets users access saved citations from within their Word or PowerPoint documents and link back into RightFind to view and request that content.
The connection between the RightFind libraries and Cite It allows teams compiling regulatory support documentation to quickly search their RightFind Shared Libraries right from within their Word document. Users can even search within a Word document by the associated tag within their library to find the exact supporting citations needed.
When used in conjunction with the Shared Libraries, teams can store all necessary documentation related to a product within a RightFind library, then retrieve the citations for that product with ease from within their Word document. For example, a Shared Library can be created in RightFind with all supporting literature needed for a device’s design history file. Tags can be applied to the literature in that library to organize that content, such as by where in the device’s design phase the literature is needed, then within Cite It those saved references can be effortlessly retrieved by filtering to the tag associated in RightFind.
With Cite It, users can also search their own personal RightFind library, their organization’s Digital Library of previously acquired articles, as well as citations in the RightFind catalog of over 165 million citations from within their document. When authoring a document, users have easy access to quickly link back to RightFind to view or request the literature they are citing. RightFind checks the rights you have to share with available sources and offers users fast access to document delivery and transactional permissions for items that are not already available.
RightFind Cite It allows teams to quickly and easily switch between citation styles to meet submission guidelines, with over 10,000 available citation styles to choose from, along with the ability to create custom citation styles.
Integrated Solutions to Support Submissions
Whether it’s compiling regulatory documentation for existing devices, new devices, existing markets or new markets, our simplified literature retrieval and reference management solutions provide an intuitive, integrated experience. Access to copyright compliant literature with centralized libraries means teams can retrieve the content they need and organize and store that literature in a way that is easily retrievable. The ability to cite literature from the RightFind libraries reduces the manual need to track down necessary citations to speed up the authoring process.
EU MDR is complex enough, with changing requirements and strict guidelines to show safety and efficacy. Retrieving, organizing, and citing content to show compliance and to support a successful EU MDR submission shouldn’t add to that complexity. CCC RightFind solutions help keep this part of the process simple for all teams involved.
Visit our RightFind Enterprise and RightFind Cite It pages now to learn more about the many features and benefits of the CCC software solution.