Choosing a CER writer for your MDR Clinical Evaluations

Dr Paul Hercock
How to choose a CER writer for your MDR Clinical Evaluation

If you are considering outsourcing your medical device Clinical Evaluations to a CEP & CER writer, you are certainly not alone.

Expert CEP & CER writers

We have a 100% acceptance rate for CERs & CEPs submitted for the EU & UK MDR.

Explore our CEP & CER writing services

Writing CERs and CEPs is a complex challenge that calls for extensive experience and a thorough understanding of the MDR, relevant guidelines and applicable standards. For this reason, many companies prefer to outsource to an expert rather than struggle internally and risk non-compliance.

However, with a broad and confusing range of support options available, how can you be sure you are choosing the best supplier for your needs? What factors should you consider when choosing a contractor for writing your CEPs and CERs?

We’ve compiled a list of considerations that will help you make the right choice when choosing a medical CEP & CER writer for your Clinical Evaluations.

1. Fixed and fair price

Sounds obvious - but do you actually know what you will need to pay? Clinical Evaluation is a complex and time-consuming process, so be wary of any offers that charge per unit time or that cap working time before extra charges kick in.

Instead, look for suppliers that will commit to a fixed price in advance with no hidden extras. This way, you’ll have control of your budget and won’t be at risk of the ‘sunken cost fallacy’.

On the flip side, be wary of choosing a CEP / CER writer on the basis of price alone - while it’s important, it shouldn’t be the only factor to be considered when making a decision.

2. Fixed timeline

Always look for a supplier that will commit to a specific completion date for the work, with regular check-ins throughout the process. This helps ensure that you stay well ahead of any submission deadlines and in full control.

A CEP / CER writer that will readily commit to a deadline on paper is generally one that has your interests at heart.

3. Do they have the right credentials?

It’s vital that those tasked with writing your CERs and CEPs are appropriately qualified to do so.

  • What assurances can you get that your potential supplier will have suitable regulatory and subject matter expertise?
  • What level of experience do they have?

Be wary of suppliers who are not open about the qualifications of their writers and reviewers; instead, look for those who provide tangible reasons why their writers will fulfil requirements for knowledge, experience and objectivity.

4. Do they claim or demonstrate expertise?

A photo of a Mantra Systems' CER Writer
There are many factors to consider when deciding on the right CEP & CER writer.

There’s an important difference between the two. Plenty of suppliers claim to be experts without doing anything to back up these claims on a public forum. To what extent have they “put themselves out there” and faced unfiltered questions from medical device manufacturers?

Look for suppliers who have shown a readiness to demonstrate their knowledge and expertise, rather than simply claim it. Be sure to check out any videos or previous Q&A sessions they have run and pay close attention to how knowledgeable they really are.

5. How good is their communication?

A prospective supplier’s website, emails and marketing material are all great ‘try before you buy’ screening opportunities that reveal the standard of writing you can expect. Don’t risk entrusting complex technical writing to a supplier who makes basic errors in their own material.

Instead, look for CEP / CER writers who adhere to the highest standards of written communication in all aspects of their business.

6. Responsiveness

  • How quickly do prospective suppliers get back to you after an enquiry?
  • Do they make you feel valued and important right from the outset, or are you left waiting while being told that ‘your enquiry is important’?
  • Is your enquiry handled personally by a named individual, or through a ‘boilerplate’ interface and a call centre?

Clinical Evaluation done properly is a collaborative process that calls for effective and bilateral communication. Look for suppliers who build an instant rapport and put you in direct contact with members of the project team.

7. Dedicated focus or bolt-on service?

Clinical Evaluation is not something that lends itself to non-specialists. For this reason, look for suppliers who focus specifically on CERs and CEPs rather than those who bury their Clinical Evaluation service amongst a multitude of others.

You can’t expect a specialist, dedicated service from a non-specialist. If you can’t easily find details of a Clinical Evaluation service on a supplier’s website, it’s time to move on.

8. Do they stand by their work?

Look for suppliers who will stand by the quality of their work and provide FREE ongoing support once the CER and/or CEP have been submitted to a Notified Body. After all, why would any company refuse to do this if they truly believed in the standard of their work?

The bottom line

Video 1: See how our Clinical Evaluation service and Literature Review writing process works from start to finish

Choosing the right CER writer is a key decision when outsourcing the writing of medical device Clinical Evaluations. Making a selection based on price alone can be a costly mistake; instead, focus on the above criteria and make a choice based on proven factors that will directly impact the quality of work delivered.

Questions? Email a member of our friendly team, or call +44(0)114 299 2599 to speak directly with one of our expert medical writers. We promise: no phone menus, no waiting, no obligation and complete confidence.

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. 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
  13. 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
  14. 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
  15. Five useful resources when writing a medical device CER

    Five useful resources when writing a medical device CER

    We outline five of the most useful and trustworthy Clinical Evaluation Report writing resources.

    Dr Victoria Cartwright Dr Victoria Cartwright Relationship Manager
  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