Author: Suzanne Broussard
Clinical evaluation is an integral part of technical documentation mandated for regulatory compliance of medical devices sold in the European Union (EU); therefore, having a well-designed and clearly written clinical evaluation report (CER) is paramount for manufacturers of both existing and new medical devices.
This is especially true with the passing of Medical Device Regulation 2017/745 (MDR). The MDR directive places stricter regulations on medical device safety and performance.
Not only are new devices seeking regulatory compliance impacted, devices on the market prior to the initiation of the MDR directive are also affected as every device must be re-submitted for CE marking before the end of the May 2020 transition period. This effect will require manufacturers to update the CER for each device to current MDR standards in order to be in regulatory compliance.
A survey of medical device manufacturers revealed that 78% of respondents do not sufficiently understand MDR, while 58% do not have a strategy in place to correct gaps in their clinical data or a process for collecting the data needed (KPMG & RAPS).
With so little time left to meet the MDR May 2020 transition deadline, consider hiring a professional to help your organization prepare the CER document.
Why is the CER Important for Marketing in the European Union?
The CER documents a device’s entire clinical evaluation process and is required to achieve regulatory compliance for marketing in the EU. Essentially, the CER outlines the assessment and the clinical data that determine if evidence sufficiently verifies the clinical safety and performance of the medical device. Furthermore, the CER is considered a living document and must be updated on an ongoing basis throughout the devices’ life cycle.
Key Updates in MDR as Outlined in MEDDEV 2.7/1 Revision 4
Device Equivalence and Risk/Benefit Profile
The MEDDEV guidance document 2.7/1 revision 4 outlines the stricter regulatory requirements placed on medical device manufacturers. Several key differences exist between the previous EU Medical Device Directives (MDD) and MDR, including the data requirements to determine device equivalency and clarification on the risk/benefit profile.
For a detailed gap analysis of the differences in the requirements for device equivalency and risk/benefit profiles between the previous and the current standards see our white paper Gap Analysis Report: MEDDEV 2.7/1 Guidance and Risk/Benefit Profile.
State of the Art is a Central Theme in the Clinical Evaluation
Establishing and describing the state of the art for each medical device is central to the clinical evaluation because it establishes a reference standard that is used to determine if the device’s safety and performance are compatible with current treatment options. This information is used throughout the clinical evaluation process and is documented in the CER.
Criterion Edge’s Founder and President Laurie Mitchell outlines steps for developing state of the art to comply with MEDDEV 2.7/1 revision 4 in the white paper “State of the Art: Best Practices and Literature Review Using DistillerSR.”
Experience Writing CER Documents Matters
Manufacturers have a lot at stake. Having experienced CER writers that can integrate the complex regulatory requirements with the device’s specific characteristics and can present the information with clarity can save both headaches and money. Pulling together the CER document requires a thorough understanding of the regulations’ meaning and, as importantly, the ability to apply the MDR regulations to each device’s specific situation.
The role of the clinical evaluator is so pivotal that expected qualifications for the clinical evaluation authors and evaluators are outlined in the MEDDEV 2.7/1 rev 4 guidance document right along with the stricter standards for device equivalency, risk/benefit justification, and scientific validity of data.
“The clinical evaluation should be conducted by a suitably qualified individual or a team.”
The list of qualifications to consider when choosing a clinical evaluator to author the CER is clearly stated in section 6.4 of the MEDDEV 2.7/1 rev 4. Foremost on this list are the author’s and evaluator’s qualifications and experience, including an advanced degree, documentation experience, and knowledge of the device being evaluated, research methodology, information management, regulatory requirements, and medical writing.
All of these requirements can be difficult to find in-house. Poorly organized or incorrect CER documents can hold up the compliance process delaying obtaining a CE mark or result in removal from the market during subsequent inspections.
Professional CER writers at contract regulatory agencies such as Criterion Edge can help manufacturers on multiple levels:
- Provide a gap analysis
- Provide a thorough knowledge of the current regulations
- Author a complete QC’ed CER document
- Review existing submission documents
- And so much more…
At Criterion Edge, our clients enjoy our transparency in the services we provide as our candid scoping includes a time frame for delivering the CER and detailed information on gaps in compliance. All of our writers have experience writing CERs and are up to date on current regulations. Providing a comprehensive analysis and subsequent solutions sets us apart from other vendors. Contact us if you would like to have a conversation about what we can do to help with your writing and regulatory needs.
Author: Ashley Self
Most CER writers work collaboratively with other writers and researchers to complete CERs that often run hundreds of pages and contain roughly five times as many citations. This is where EndNote’s more advanced and collaborative features shine. Within EndNote, medical writers can share libraries and even view/share notations they make on the reference’s corresponding full-text PDF. EndNote also allows writers to group resources and filter out unwanted resources via its robust search functionality.
These 11 EndNote features are sure to increase your efficiency on your next CER project:
Having access to the full text PDF of every resource in your EndNote library is indispensable when working collaboratively. Writers and analysts working over a shared library (covered below) can discuss, highlight and mark-up certain sections of the article when deciding what and how to include the resource’s data points and findings.
EndNote automatically searches for and downloads available PDFs for all citations you import. Note: You can help it by adding your company’s open URL. Open EndNote Preferences > Find Full Text > and input the URL in the OpenURL field. If necessary, add a URL to the Authentication field.
If some resources in your library don’t have the full text PDF attached, you can manually locate those PDFs by selecting the reference or group of references in your list and going to: References > Find Full Text. If EndNote can’t find the PDF of your reference, you can find and download the PDF manually online. Then, in EndNote, select the reference from the list and attach the PDF by clicking the paper clip icon in the lower right window. Or go to: References > File Attachment > Attach File.
If you have a PDF but don’t have the reference for it in your list, you can import the PDF by going to: File > Import > then click Import Options and choose PDF File or Folder > Then select the item you want to import. Using this feature, you can also import an entire folder of PDFs by selecting the Folder and clicking Import. Or, you can designate a folder for EndNote to import from any time you add a file to that folder. Go to: EndNote > Preferences > select PDF Handling from the menu on the left, check the box to Enable automatic importing and select the designated folder. Note: Some older PDFs or scanned PDFs may not contain sufficient metadata.
To markup an imported PDF, click on the reference and open the PDF in its own window. You can then use most standard Acrobat tools to annotate or call out text or sections within the PDF. Note: EndNote can even search your notations.
While most CER writers use a research tool like Distiller SR to locate and screen data studies and resources, EndNote can also be used effectively as a screening tool by way of its Groups categorization and Duplicate Detection tools. In one case, a writer was able to narrow a search resulting in 500 entries (some of them junk) into a small batch of highly relevant resources by filtering out duplicates, outdated data, conference abstracts, non-relevant or excluded keywords, and study types, all in EndNote.
Categorizing existing references from your library into groups makes working with large reference libraries much easier. Particularly when working with CERs when a wide net of data gathering must initially be cast. Many medical writers use EndNote’s Groups feature as a search or screening tool by inputting specific keywords, study types, or journals into the search criteria, and even using specific keywords to exclude unwanted references. Internally, the Groups feature can be used to temporarily flag articles that need further review, need full text, or need additional notations. By assigning a 1- to 5-star star rating to these entries, you can later use the Groups feature to search for those entries by rating and process them accordingly. This is a great way to batch find and process reference groups that don’t necessarily share a common keyword, author or title.
Smart Groups is an automated feature that tells EndNote to automatically add references that meet a specified criteria to a group. Setting up specific Smart Groups in advance is well worth the time as it automates a manual search step. For example: you can tell EndNote to automatically add any new or existing resources that contain the keywords heart valve and the date of 2018 to a 2018 Heart Valve group. To use this feature, go to Groups > Create Smart Group and input the search criteria you desire. Subsequently, any matching reference you add to your library will automatically be added to that group.
Medical writers may also use the Group feature to create new groups from existing groups. Choose Groups > Create from Groups and then input your inclusion/exclusion criteria. For example, say you have created various groups for different types of heart stents and you want to combine some of those groups into a new group. You can select to include the types of stents you want and exclude those you don’t.
Note: The Smart Group feature can even be programmed to search the full text PDF attachment and even your notations within the PDF.
EndNote also has a robust tool for reconciling Duplicate entries. This is a recommended first and final step (when you first import your references into a new library and before you finalize your document) and can be done by going to the References menu > Find Duplicates. This will generate a list of duplicates. From there you can simply delete the outdated references, or click on them to review the data included within each reference, copy and paste desired data into the most recent reference, and only keep the most up-to-date entry.
Library sharing is one of the most attractive advanced features of EndNote and one CER writers use regularly. When multiple users are working on one CER, it is critical that they have viewing and notation access to all the references. The primary creator of the reference library can share the library with up to 100 users (version X8). Anytime any of the users makes a change to the library or notation within in a reference, EndNote keeps track and other users can view the list of changes.
To use this feature, all users must first set up an EndNote Online account. Then, the primary user can sync their library online (this takes a while) and then elect to share the library with a list of users (specified by email address). Recipients will be notified via email and can accept access and then have full privileges within the library. Because the library is constantly changing, the original owner of the library should make periodic backups of the current version via File > Compressed Library.
Similarly, if you are working on multiple devices you can sync your EndNote library across those devices. In order for any changes or updates to transfer to other devices, all devices must be online. Once you have synced your existing library online, open EndNote on the new device and go to: File > New. Here you must create a new library file of the exact same name as the library file on your current device. Then, simply sync that file. (Remember, initial syncing takes some time. Subsequent synced updates happen every 15 minutes and when you close EndNote…and are much quicker.) Now you can work from multiple devices and rest assured your changes will be updated.
When working with new clients, you may receive multiple documents with embedded citations, without receiving access to the related EndNote library. You can still access those references by exporting those citations into a Traveling Library. Go to the EndNote menu > choose Export to EndNote > Export Traveling Library. All the resources cited in the document will be added to your specified EndNote library.
In addition to its most basic features, EndNote can serve as a valuable, time saving tool for CER writers tasked with managing large databases of references. EndNote makes collaborating with multiple writers seamless and efficient, and its group and search capabilities make filtering through added references and managing existing ones much more organized. Note: EndNote is a dynamic and active tool, so don’t forget to unlink the final Word document from EndNote before you send it for review.
Author: Ashley Self
Using a reference manager like EndNote while writing a massive, reference-heavy document like a CER is certainly a game changer for medical writers. EndNote’s core features like Cite While You Write are indispensable when it comes to saving valuable time and keeping thousands of data references organized.
However, EndNote’s more advanced features, like PDF markups, reference library sharing and groups, are particularly valuable to CER writers who typically collaborate with multiple writers, researchers and analysts on one document, and also have to update older inherited CERs they didn’t originally write.
In this article, we’ll cover some of EndNote’s basic features. If you are already familiar with those, you can jump to our next blog on how to make the most of EndNote’s more advanced features when writing your next CER.
Cite While You Write is an EndNote plugin that allows you to add, manage and edit EndNote citations directly from Word while you are working in your document. It is simple to install and you are able to access all of EndNote’s features without leaving Word, which means you can search for, sort, and edit resources seamlessly as you are writing. Just make sure the EndNote library related to the project you are working on is open in EndNote.
EndNote has a database of more than 6,000 citation styles that are updated periodically. Most CERs use the AMA style, however, sometimes writers may be required to use a different style or even make a minor change to an existing style. Occasionally writers may receive a draft document from a client that was cited using a different style.
You can find new or updated styles on EndNote.com. Search for Output Styles and download the ones you want. Then go into your downloads folder, open the new styles in EndNote and save them. You can then access them in EndNote by going to Open Style Manager and searching for the new style.
Perhaps your reviewing body or client wants you to use the AMA style but with a slight variation in the way things are abbreviated. In that case, you can create a custom style based on the existing AMA style. Go to: Edit > Output Styles > Open Style Manager > Find your style and click Edit > Using menu on the left, select the section you would like to edit and choose Templates. Then make any changes to the corresponding template fields. When done, save the file under a new name.
Because CERs and other medical regulatory documents are often hundreds of pages long, it is sometimes preferable to create sub-reference bibliographies for each main document section. To do this for each of your document chapters, you can edit the Bibliography Style you are using. Go to: Edit > Output Styles > Style Manager > Find your style and click Edit > Using the menu on the left, click on Sections. Here you can choose to have the bibliography at the end of the document or at the end of each section, or both. Save your changes. Then ensure that, within your Word document, each unique section is separated by a “section break”. Note: if your document template or standard formatting contains section breaks for other purposes (such as tables), you will see a bibliography after each section break, so, this style may not work efficiently in those cases.
When working in an already complex CER document, EndNote’s core functionality makes managing large batches of references and citations fluid and virtually error-free. Already, using just these basic features will save medical writers substantial time and mental energy.
When you are ready to dig into EndNote’s more advanced features, you will find it helps with much more than just document citation management.
Stay tuned for the second part of our EndNote series: Managing CER Writing Better with Endnote: Advanced.