March 11, 2020

[FEATURED] Premarket Innovators And SMEs (Part 2): Running Out Of Time In The EU MDR Race

In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with the EU MDR application date now less than four months away.

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January 24, 2020

Systematic Literature Review to Help Meet MDR Requirements

Get a copy of the slides from this webinar or click to watch the recording.

Companies face constant pressure to meet the increasing regulatory expectations and demands for information. Data identification through Systematic Literature Review (SLR) supports critical regulatory functions throughout the company, from MDR requirements through IND submissions.

In this session, we review:

  • How the use of published data can support regulatory expectations
  • When to conduct a systematic literature review
  • Best practices for conducting a methodologically-sound SLR
  • The tools and technology available for SLR
  • Real world case studies about leveraging SLR

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This webinar is co-hosted by Criterion Edge and RAPS.

Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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November 14, 2019

Systematic Literature Review: How to Empower Data-Driven Decision Making

SLR Webinar Title Slide

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Companies face constant pressure to conduct comprehensive data-gathering activities in response to increasing regulatory expectations and demands for information. Data identification through Systematic Literature Review (SLR) supports critical functions throughout the company, from MDR requirements through IND submissions.

This session will review currently accepted SLR best practices and provide practical guidance for designing and conducting a rigorous literature review, from search strategies through screening and data extraction. Case studies will provide real-world examples of how data identified through the SLR process helped inform the decision-making process.

Our President Laurie Mitchell joins Jennifer Tetzlaff, Research Product Specialist with Evidence Partners, to talk to you about the following points:

  • Examples of how the use of published data can support regulatory expectations
  • When to conduct a systematic literature review
  • Best practices for conducting a methodologically-sound SLR
  • Use of available tools and technology

This webinar is co-hosted by Criterion Edge and Evidence Partners.

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October 1, 2019

What role does the CER play in getting a Medical Device Approved for Marketing in the EU?

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. 

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[WEBINAR] How to Assess Your CER for MDR Readiness Part 1: State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review

Join our President, Laurie Mitchell, on April 29, 2020, at 11AM PST / 2PM EST to align your CER with some key MDR requirements. This live webinar will help you assess your CER and identify possible gaps for mitigation before submission.

Attendees are eligible for a free consultation and scan of their CER (or CER template). Spots are limited – click to register for this free webinar.