Five useful resources when writing a medical device CER

Dr Victoria Cartwright
Five useful resources when writing a medical device CER

Writing a Clinical Evaluation Report (CER) is one of the most demanding aspects of preparing a medical device submission under the EU MDR. It calls for a comprehensive appraisal and analysis of all clinical evidence relating to the subject device, along with an objective analysis of data relating to the clinical background and comparable alternative devices.

Video 1: Five common pitfalls when writing a Clinical Evaluation Report

Because of the breadth of ground each CER needs to cover, they invariably become weighty documents often running to hundreds of pages. As a result, it’s very easy to become lost. It’s therefore vital to know how to structure the document and keep track of all the different sections.

Luckily, there are several resources available to help. Not everything out there is authoritative or reliable, so in this article we outline 5 of the most useful and trustworthy resources to use when writing a medical device CER.

Resource 1 - The MDR itself

The old phrase “talk to the organ grinder, not the monkey” is as applicable to medical device regulation as it is elsewhere in life. The MDR may not be the easiest document to work with, but there’s little substitute for going directly to the legislative source for direct guidance on requirements for CERs. The most relevant sections are:

  • Article 61 - which sets out core rules and expectations for Clinical Evaluation
  • Annex XIV Part A - which provides a line-by-line top-level overview of expected contents

While it would be improper to expect detailed guidance from the MDR, the highlighted sections provide the backbone around which the other resources fit, so it’s vital to understand them. The good news is that we’ve made working with the MDR easier than ever - download our free Mastering the MDR White Paper to see what we mean.

Resource 2 - MedDev 2.7/1 rev 4

MedDev 2.7/1 rev 4 was the go-to resource for CERs under the MDD. It’s one of several official medical device guidelines produced directly by the Commission and can therefore certainly be regarded as authoritative. It’s also comprehensive and addresses many aspects of performing Clinical Evaluation in detail.

The major drawbacks to the MedDev are that it is difficult to work with and, vitally, hasn’t yet been updated to reflect changes introduced by the MDR. As a result, it’s no longer the bulletproof resource that it used to be. It also fails to provide any guidance on the use of language and styling, meaning that it’s easy to still feel ‘out at sea’ even after reading it.

Having said all that, it continues to be a useful resource even allowing for its outdated status. While it would be a mistake to rely on MedDev 2.7/1 rev 4 in isolation, it should still be part of your CER arsenal. As to whether it’s likely to be updated any time soon - unfortunately, that remains an open question for now.

Resource 3 - MDCG 2020-13

Written by the Medical Device Coordination Group, the set of MDCG Guidelines comprise a useful set of guidance that generally focus on specific aspects of medical device regulatory activities. They are useful for multiple activities including PMCF and planning and implementing clinical investigations.

MDCG 2020-13 is especially interesting since it provides a template for a Clinical Evaluation Assessment Report. In other news, it can be thought of as providing the ‘marking sheet’ that Notified Bodies will use when assessing a CER. It’s a great way to validate an existing draft CER and a useful resource to incorporate into planning; accordingly, MDCG 2020-13 is a must-have resource that is free to download and relatively easy to work with.

Resource 4 - Other MDCG guidelines

MDCG 2020-13 isn’t the only MDCG guideline that can be helpful during Clinical Evaluation. Depending on the circumstances, there are two others that are worth downloading if they are relevant to your device:

  • MDCG 2020-6 - Provides specific guidance for performing Clinical Evaluation on legacy devices - i.e. those previously CE-marked under the MDD
  • MDCG 2020-5 - Offers detailed guidance on making a claim of equivalence

As with the other MDCG guidelines, these are free to download and definitely worth reading through if relevant to your device.

Resource 5 - CER Templates

Video: See how our Clinical Evaluation Report writing service works from start to finish

Even with all of the above resources available, writing a CER can still be a daunting prospect. Many people therefore reach for CER templates, with many of varying quality available on the internet. Beware - using the wrong template will seriously derail the Clinical Evaluation process. It’s imperative that the template will enable the production of a CER that will meet requirements, otherwise it’s a waste of time and money.

The good news is that we have made our proprietary CER Template available to download. This unique 64-page template offers unparalleled levels of guidance for writing CERs for any type of medical device. Fully updated to reflect all the latest requirements, our template goes way beyond any other and includes:

  • line-by-line guidance on all parts of every CER section
  • illustrative examples, showing not just what to write, but how to write it
  • sections of ‘device agnostic’ text that can be transposed directly into your CER
  • a lifetime of free updates, meaning you’ll always be in possession of the latest guidance reflecting any changes in the industry

Read more about our CER Template. Alternatively, remember that we offer a full CER-writing service as well as bespoke options. Please get in touch with any questions.

Related articles

  1. Considering a medical device's intended purpose

    A medical device's intended purpose - what is the point?

    How do you define intended purpose, indication for use, intended clinical benefits, and claims?

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  2. Mantra Systems presents EnableChat, your AI-powered MDR & MDCG chatbot

    EnableChat - Your AI-powered MDR and MDCG chatbot

    Search the MDR and MDCG documents in seconds by asking EnableChat your questions.

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  3. Searching adverse event databases for vigilance data

    Staying vigilant - A guide to searching for adverse events data

    We discuss the pros and cons of existing adverse event databases for vigilance data searching.

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  4. A doctor reading an SSCP document with a patient

    What is Summary of Safety and Clinical Performance (SSCP)?

    We explain what the SSCP is, when you'll need it and what its objectives are.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  5. A pile of question marks

    Medical Device 'Significant Changes' – Navigating EU MDR Article 120(3) using MDCG 2020-3 rev. 1

    Understand what changes to your medical device are considered 'significant' under EU MDR (2017/745).

    Shen May Khoo Shen May Khoo Junior Regulatory Specialist
  6. A signpost giving unsure directions

    MDR or IVDR - A sibling rivalry?

    A guide to easily understanding whether your device is a medical device or an in vitro diagnostic medical device (IVD).

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer
  7. An EU and UK flag

    What the latest Brexit U-turn means for CE Marking of medical devices in Great Britain

    Will Great Britain continue to allow the use of the CE mark for medical devices beyond the 2024 deadline?

    Dr Hanna Gul Dr Hanna Gul Lead Medical Writer
  8. A woman writing her own medical device regulation documentation

    Gain confidence, reassurance and control over your EU MDR strategy

    Find out how to build your own technical files within a guided framework while minimising financial outlays.

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer
  9. Racing to achieve MDR compliance

    Still racing to achieve MDR compliance? A transition period update

    On January 6th 2023, the EU commission has adopted the proposal to extend the transition rules of the EU MDR.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  10. A 7-step guide to navigating regulatory requirements for medical device start-ups

    A medical device regulations guide for start-up companies

    We present a 7-step guide to navigating regulatory requirements on a budget.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  11. An update on UKCA Marking of Medical Devices

    UKCA Marking of Medical Devices – An update on the status quo

    We review recently updated requirements for UKCA marking and what it means for your regulatory strategy.

    Dr Hanna Gul Dr Hanna Gul Lead Medical Writer
  12. How to choose a CER writer for your MDR Clinical Evaluation

    Choosing a CER writer for your MDR Clinical Evaluations

    We've compiled a list of considerations that will help you make the right choice when choosing a CER writer.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  13. Achieving MDR Compliance for Class I medical devices

    How to achieve MDR Compliance for Class I medical devices

    We outline a strategy for the regulatory compliance of Class I medical devices.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  14. Literature Search, SOTA Review and Clinical Evaluation

    Literature Search, SOTA Review process and Clinical Evaluation

    We help to demystify the process of systematic search & review of literature for Clinical Evaluation.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  15. Literature Search Protocols & SOTA Reviews for medical devices and what to know before you start

    Literature searches and reviews for medical devices - what to know before you start

    We explain what you should know before beginning a literature search & review for your medical device.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  16. Avoid pitfalls when writing a Clinical Evaluation Report

    Five common pitfalls when writing a Clinical Evaluation Report

    We illustrate five pitfalls when writing CERs and give you some tips to overcome them.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  17. How to make a medical device equivalence claim under the MDR

    Five tips for making a medical device equivalence claim under the MDR

    We'll show you what to keep in mind with regards to equivalance and Clinical Evaluation.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  18. Keeping medical devices in market and maintaining CE-marks - a guide to effective data collection

    Keeping medical devices in market and maintaining CE-marks

    The 4 golden rules to drive regulatory compliance with PMCF and vigilance data collection.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  19. How PMCF goes beyond simple compliance - improving products and engaging customers

    How PMCF goes beyond simple compliance

    The wider benefits of a well-designed PMCF system include improving your products and your relationship with your clients.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  20. PMCF systems for medical devices

    Why you'll almost certainly need a PMCF system for your medical devices

    We tell you what to be aware of under the EU MDR regarding PMCF and your medical devices.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  21. Ensure medical device regulatory compliance of your devices through Brexit

    The impact of Brexit on medical device regulatory compliance

    How to ensure regulatory alignment of your devices in the territories affected by Brexit.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  22. Use medical device regulatory consulting services to supercharge your MDR transition

    Is outside consulting support the answer to your MDR transition?

    Getting ready for the MDR is a demanding process. Outsourcing might be your solution.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  23. Increasing data entry compliance in PMCF studies

    Increasing data entry compliance in PMCF studies

    5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  24. Why medical doctors can drive MDR compliance

    Why medical doctors can drive MDR compliance

    Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.

    Dr Victoria Cartwright Dr Victoria Cartwright Relationship Manager
  25. Software as a Medical Device

    Software as a Medical Device

    Unless you have spent time working with medical device legislation in the past, the idea that software could be a medical device may be rather unexpected.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  26. clinical investigator for pmcf eu mdr compliance

    Ensuring that clinical investigations work in practice

    How can medical device manufacturers ensure valid clinical investigations when access to medical expertise remains limited?

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  27. Coronavirus and medical device regulations

    Relaxing medical device regulatory requirements during a healthcare crisis

    During the coronavirus pandemic, how far should we go when relaxing medical device regulatory requirements?

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  28. The new MDR compliance challenge

    The new MDR compliance challenge

    Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  29. Sources of Real World Evidence for MDR compliance

    Sources of Real World Evidence for MDR compliance

    At Mantra Systems our objective is to make sure that our clients choose the method of real world data harvesting that is right for them.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer

More articles

Do you need help with your regulatory strategy?

Talk to us