Are you looking for strategies for the verification of device safety and performance in the clinical evaluation? Are you struggling to define device safety and performance objectives? During this 45-minute Q&A session, our President Laurie Mitchell answers questions regarding how to identify meaningful safety and performance endpoints. In addition, she discusses how to demonstrate safety and performance objectives are appropriate and clinically relevant as well as what acceptance criteria is and how to define it.
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs. If you attended our hour-long webinar on August 25, but we did not answer your questions we encourage you to attend to get your questions answered on this topic.
All medical devices selling in Europe must have a Clinical Evaluation Report (CER). Specific and measurable safety and performance endpoints are paramount for an acceptable CER. However, many small medical device manufacturers are struggling to adequately define and subsequently document measurable safety and performance endpoints, especially in the literature review, to support an evidence-based evaluation.
The newest regulations for medical devices, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously, regulations under the old MDR and MEDDEV were not as demanding. Also, manufacturers are not accustomed to the current systematic process of CER evaluations.
Read more on this topic in our recent blog post, Clearly Defining Measurable Safety and Performance Endpoints in Clinical Evaluation Reports (CER) is a Real Challenge for Medical Device Manufacturers.
In this presentation we discuss strategies for the verification of device safety and performance in the clinical evaluation. Our seasoned CER medical writers are rooted in MDR-compliant practices. Likewise, this presentation will help you identify meaningful safety and performance measures for the clinical evaluation. In addition, we will define parameters to determine the acceptability of benefit-risk. Afterwards, we will have about 10-15 minutes to answer any questions you may have on this topic.
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve CERs for EU MDR submission. Anyone interested in learning more about MDR requirements for CERs is encouraged to come too. We encourage attendees from the IVD industry to attend as well, as the content is also relevant to IVDR requirements, which align closely with MDR.
All medical devices selling in Europe must have a Clinical Evaluation Report (CER). Specific and measurable safety and performance endpoints are paramount for an acceptable CER. However, many small medical device manufacturers are struggling to adequately define and subsequently document measurable safety and performance endpoints, especially in the literature review, to support an evidence-based evaluation.
The newest regulations for medical devices, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously, regulations under the old MDR and MEDDEV were not as demanding. Also, manufacturers are not accustomed to the current systematic process of CER evaluations.
Read more on this topic in our recent blog post, Clearly Defining Measurable Safety and Performance Endpoints in Clinical Evaluation Reports (CER) is a Real Challenge for Medical Device Manufacturers.
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.
Author: Katherine Lalicker, Editor: Ashley Self
Managing your figures, tables, references, and so much more on a lengthy, complex regulatory document can seem impossible. Even seasoned medical writers struggle when trying to make changes or add content without breaking a document. Chances are, the tools you need already exist. Read on to find out how some of the simplest Microsoft Word tools can allow for smooth changes to maintain an organized, uniform document.
CER documents need to be clear and uniform, which can make it difficult to pull content from one document to another without disturbing the style of the document. There are multiple paste options that allow you to either match the formatting of your document or paste text without any formatting. All options can be found under the Home tab on the toolbar in the copy and paste section. Two important functions for CER writing are Match Formatting and Keep Text Only.
In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
This white paper is a companion piece to our popular webinar where we share our insights on using the Systematic
Literature Review (SLR) to Empower Data-Driven Decisions in your Organization.
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
In this webinar, Dr. Sarah Chavez provides an overview of the State of the Art section, and explains how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER) in a reasonable time frame. A complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed to establish that your IVD may be considered “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.
This white paper is a companion piece to our popular webinar where we break down the steps of the systematic literature review (SLR) process and take a wholistic approach to conducting an In Vitro Diagnostic Regulation (IVDR)- compliant SLR.
This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it
fits into the In Vitro Diagnostic Regulation (IVDR).
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.
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.
This white paper is a companion piece to our popular webinar where we share some of the best approaches we have
discovered for Corporate Scientific Communication Strategies.
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.
This white paper is a companion piece to our popular webinar that uncovers what we have learned from our experience in writing Medical Device Regulation (MDR)-compliant Clinical Evaluation Reports (CERs), and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
This white paper is a companion piece to our popular webinar where we share some of the biggest issues we have discovered when starting a Clinical Evaluation Report (CER) project, and how to anticipate and avoid project delays.
This companion piece to our popular webinar discusses strategies for assessing key components of your CER like clinical data sources and risk-benefit analysis.
This white paper outlines strategies to assess your CER including state of the art, safety and performance criteria, equivalence and systematic literature review.
Have the IVDR Performance Evaluation and Post Market Surveillance requirements got you tied up in knots? Where do you start? What does the end product look like? We are joined by the VP of Regulatory, Quality, and Clinical from Nextern, a collaborative medical device company bringing unmatched core competence in medical device product design and development. Criterion Edge’s President Laurie Mitchell will lead a discussion of their experiences supporting clients through MDR and IVDR requirements.
In this practical presentation, President Laurie Mitchell will: 1) discuss how an effective scientific communication plan is an important marketing tool for an organization, and 2) present five strategies to ensure your corporate objectives are supported and maximize the real-world impact of your data. Join us to learn how this applies to your organization and how to implement these strategies into your current processes.
In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER, needing more up-front planning than the reports have in the past. Based on our experiences with clients both large and small, our President, Laurie Mitchell, shares some of the biggest issues we have discovered when starting an MDR CER project. Laurie also reveals some of the most successful strategies in addressing these issues, up-front and early.
In this second installment of our 2-part webinar series, Criterion Edge shares practical presentation to help you assess your CER through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities.
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
Watch this video to learn how Criterion Edge is different from the rest.
This infographic goes through 5 key questions to go through in order to control your budget.
Leading industry experts come together to discuss how the MDR affects data management within their respective units.
This report clarifies the modifications to the equivalence guidelines in MEDDEV 2.7/1 and Quality Management Systems (QMS) ISO 13485 standard to help develop strategies.
This gap analysis addresses key revisions to evaluator qualifications and scientific validity in the Clinical Evaluation (CE) MEDDEV guideline rev.4.
The changes to 2.7/1 rev. 4 suggest the need to submit more frequent CERs to regulatory authorities, however, strategies will be discussed for managing the increased requirements.
Every time a healthcare provider makes a notation in the medical chart, a significant and valuable piece of data has been created. This paper discusses the implications of this.
This piece discusses 10 key strategies to building an efficient regulatory writing process.
In this paper, we discuss a prominent clarification on the MEDDEV 2.7.1 rev 4, establishing the “state of the art” section.
The overwhelming turnout at the ‘How to Assess Your CER for MDR Readiness, Part 1’ prompted us to host a live Q+A session where President Laurie Mitchell exclusively answers all your questions.
President Laurie Mitchell returns to continue sharing more about the importance of the systematic literature review.
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management, and equivalence.
In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements.
In this webinar, President Laurie Mitchell discusses why safety reviews are essential in the entire life cycle of product development.
Kyoko Hattori from Criterion Edge returns to discuss best practices for managing the adjudication process in-house, and Brian Kelly from AG Mednet will share how the “JUDI” platform can simplify the management of adjudication.
In this webinar, learn about CECs, familiarization with regulatory guidance, decision factors leading to use of a CEC, and much more.
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