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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July 15, 2019

Ask the Experts: What does MedDev 2.7/1 rev.4 mean for new and existing products?

Author: Douglas McGarvey

Criterion Edge chats with regulatory authorities and other medical device and pharmaceutical industry experts to share their viewpoints on topics that impact our industry. With this expert advice, we aim to keep you informed about current developments and encourage discussion among those of us who work in large and small medical device, pharmaceutical, or biologic companies, CROs and other industry groups. Our goal is to offer up-to-date and reliable information to help you navigate the regulatory landscape and gain a better understanding of critical issues that affect our industry.

Follow this column/blog to get notified of similar articles. And if you have questions to ask these experts, submit your own questions to us.

NOTE: This forum is not meant to provide legal advice or official policy for any participant. It is simply provided as a discussion between Criterion Edge and various experts for the purpose of sharing the thoughts and opinions of participants.


Ask the Experts: Revision of MedDev 2.7/1 and Clinical Evaluation Reporting

We spoke with an expert from a major European notified body about how companies can prepare for revision 4 of MedDev 2.7/1 and upcoming changes in MDR rules. We discussed how these new regulations affect both new and existing products. Our expert says that the new MDR regulations pose serious implications for clinical evaluation reports based on literature review.

In the future, it will not be acceptable to build a clinical evaluation report (CER) based on literature instruction. This is a significant change! To put this in context, some 80% of products placed on the European market today are based on literature research. Industry experts think that that number will shrink to about 10% following the new MDR requirements.

What does this mean for new products?

For a new product, a literature review will no longer be sufficient to establish equivalency with an existing product. Manufacturers must establish equivalence between the medical device and its equivalent comparator. This requires comparison of devices for clinical application, biological compatibility features and technical parameters. In order to prove that these features are the same for the two products, companies will need to have access to the technical documentation of the equivalent product. It’s not sufficient to simply bring the other product to the laboratory and test it. Manufacturers will need to have two sets of technical documentation. Otherwise, the product equivalency will not be accepted.

For ongoing/annual updates, clinical literature will continue to be important. However, since there is no grandfathering of certificates, every new product will basically get to the European market in the first place based on MDR.

What about an existing product?

Once the MDR changes are in effect, the certification of many existing products will no longer be valid. Even if an organization certifies today, the certification will not be grandfathered into the new system. Every organization will need to go through the new certification process based on the new rules that go into effect in May 2020. It’s important to note the limited timeframe for the new certification process, so companies need to plan ahead.

With regard to current CERs, companies will need to revise and update all clinical reviews. First, they will need to update all of the initial CERs to meet Rev 4 of the guidance document, which is actually very close to the MDR requirements.

Crucially, it will not be acceptable to just focus on safety in order to update the report. It will be necessary to go back and prove the clinical safety of the product in the first place and then to provide updates. This is a major issue for both small and large companies.

Many companies will need to perform clinical studies and, in many cases, retrospective clinical studies. They’ll need robust programs for post-market clinical surveillance (PMCS) and post-market clinical follow-up (PMCF). With the changing rules, manufacturers will need to take a proactive, not a reactive approach, to stay compliant. Companies will need to have a very strong PMCF plan, which is different from requirements in MedDev revision 3. 

What sort of reporting is required?

Significantly, companies will need to proactively collect PMCF data. Then, depending on the product classification, they will need to produce two yearly reports with clinical data – a Product Safety Update Report (PSUR) and a Summary of Safety and Clinical Performance (SSCP). The data posted in those reports will come from the company’s post-market follow-up activities.

The Commission is creating guidance documents to clarify what it wants to see in these reports. But this reporting is not the same as a regular CER update. The two efforts must be done in conjunction with each another.

But writing the annual reports is just the beginning – evaluation of the reports is also necessary. Companies must upload the annual reports to Eudamed, the European Databank on Medical Devices, and the manufacturer’s notified body will review those reports each year.

Current discussions among notified bodies suggest that the Eudamed databank will be available by the end of the transition period or the month prior to the implementation in May 2020.

Further guidance

For further guidance, the Notified Body Operations Group (NBOG), a membership organization of European notified bodies, may be publishing papers with their interpretation of the regulations.


‘Ask the Expert’ is published by Criterion Edge, Inc. Criterion Edge, Inc. is a regulatory writing company that provides outsourced writing services to the pharmaceutical and medical device industries. The company’s expertise in regulatory writing best practices, honed over decades, produces superior deliverables and provides budget, resource and timeline flexibility for regulatory managers. We empower companies to deliver superior health care solutions. To learn more about how we do this, click here to contact us.

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July 3, 2018

[FEATURED] New Reasons Not To Use EU MDR’s Four-Year Extension, But Comply Earlier Or Retire Products Instead

The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four years under current directives. But more hurdles are being identified that make this option less attractive.

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June 20, 2018

[FEATURED] Substantial Drop In Certificates Withdrawn By EU Notified Bodies: Why Now?

Data from TEAM-NB, the EU notified body association, shows a big drop in withdrawn certificates from device firms. Does this signal an improvement in the quality of manufacturers’ submissions to notified bodies?

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May 30, 2018

Developing the state of the art section of the CER: challenges and pitfalls

There is no doubt that establishing state of the art is a challenge. It ranges from key information on the medical condition to a neutral, comprehensive analysis of treatment options, and culminates in a succinct yet comprehensive presentation that defines the currently accepted safety and performance standards against which the device is measured. Not surprisingly, common pitfalls include a perspective that is too broad and inclusion of too much detail, or a perspective that is too narrow, omitting relevant indications and alternative therapeutic options. An important critical aspect of the clinical evaluation that relies on state of the art data is also to appropriately define the position of the device within the currently available treatment portfolio.

(more…)

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