Clinical Evaluation for all classes of medical device

100% CER submission success rate from a international team of expert medical consultants

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Clinical Evaluation Reports for EU & UK market access

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Professional CER & CEP writing for EU & UK market access

Our international team of over 50 subject matter experts are specialists in handling large projects producing multiple Clinical Evaluation Reports & Plans in parallel.

  • CERs written for EU & UK MDR compliance
  • For all classes of medical device in any clinical field
  • Fully insured ISO & TOPRA-registered consultants
  • Complete Meddev & MDCG compliant CER writing service
  • Appropriately qualified CER signatories
  • Scalable capacity servicing a worldwide client base from start-ups to multinationals

Complete CER writing service for all device types & classes

Our expert team of medically trained CER writers will bring unrivalled clinical evidence appraisal & analysis to your medical device Clinical Evaluations.

  • New Clinical Evaluation Reports & Plans
  • Updates to previous CERs & CEPs
  • Review of existing Clinical Evaluations
  • Literature search protocols & SOTA reviews to support CER production
  • Responding to Non-Conformity Reports (NCRs)
  • Working with tight deadlines & re-submissions
Workers in an office

Our Clinical Evaluation promise

Dedicated CER specialists will ensure your medical devices are compliant, while being clear and transparent with you every step of the way.

  • Rapid quote & set prices with no hidden extras
  • Fixed timelines with a commitment to meet your deadlines
  • Allocated project team & named primary contact
  • Direct & constant visibility of project progress
  • No final payments until 100% client satisfaction
  • Ongoing support after CER submission to Notified Body with no additional cost

Want to talk to an expert? Send us your details and we'll get back to you…

Our Clients say

Mantra Systems have provided outstanding quality literature search reports and State of the Art appraisal reports for our Oral Care Medical Devices. Mantra Systems have worked closely with us to allow our pre-existing Clinical Evaluation Report structures to be updated by them, thus minimizing document structure changes observed by our Notified Body. The reports delivered by Mantra Systems have fully met our needs and those of our Notified Body. Mantra Systems have worked hard to meet our specific needs and have been a pleasure to work with; I would thoroughly recommend them.


Dr. Trevor Day Principal Scientist Procter & Gamble, UK

Our Clincial Evaluation process

We have developed our successful EU & UK MDR Clinical Evaluation process to help get your medical device compliant first time.

  1. Initiation

    We start by allocating you a dedicated medical writing / literature review team of regulatory experts and medical professionals with clinical experience in your device's field of use.

  2. Technical file review

    We will conduct a thorough review of all relevant technical files shared under a framework of confidentiality and IT security.

  3. Literature searches

    Research questions and search terms are developed and initial searches are run in a minimum of 2 databases.

  4. Relevancy screening

    A full relevancy screening is conducted against specified inclusion/exclusion criteria, duplicates are removed and all exclusions are tracked, recorded and justified.

  5. Literature review

    The literature review team conducts appraisal and analysis according to specified search protocol.

  6. CER writing

    Lead medical writers produce a 14-section CER using proven structure and integrating outputs of literature review.

  7. Client draft review

    Draft submitted for review at your pace and capacity. A review call is then held, feedback collated and adjustments made.

  8. Finalised CER

    The result is a professional, MDR-compliant CER meeting all relevant requirements and integrating systematic literature reviews.

  9. Post-submission

    We then offer unlimited support with Notified Body reviews, standing 100% by our work and giving you complete peace of mind.

  10. Outcome

    Our goal is full approval of your devices. Get in touch with our team for a free, confidential & no obligation discussion.

Our Clients say

  • I really appreciated your job on our medical device CER. It was truly amazing how you managed to get all this done in such a short notice. I'm very pleased with your work.


    Chief Executive Officer Manufacturer, France

  • The work was performed to excellent standards with every part surpassing expectation. The final Clinical Evaluation Reports were of an impeccable standard that I am incredibly confident using going forward as part of my technical files.


    Regulatory & QA Manager Manufacturer, UK

International team of subject matter experts

Mantra Systems are specialists in handling large projects producing multiple CERs & CEPs in parallel.

Our international team of subject matter experts are active healthcare clinicians who are specialists in their field. They offer an unparalleled ability to critically evaluate the safety and performance of a medical device, with specific insight into how the device directly impacts patient care. The nature of our distributed team also means we can scale resources to handle a project of any size.

We match projects to a subject matter expert who works within the clinical field of the device under evaluation, providing the perfect foundation for a medical device Clinical Evaluation Report.

We have over 50 subject matter experts based in the UK, Europe, USA, Canada, South Africa, and India. Their specialities include:

  • Anaesthetics
  • Cosmetic surgery
  • Elderly care
  • Emergency medicine
  • General practice / family physician
  • Intensive care
  • Internal medicine
  • Maxillofacial surgery
  • Obstetrics / gynaecology & neonatal care
  • Ophthalmology
  • Orthopaedics
  • Rheumatology
  • Upper & lower GI surgery
  • And many more…

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Clinical Evaluation in context

What is Clinical Evaluation?

Clinical Evaluation is a systematic and planned process to assess the safety and performance of a medical device.

The objective is to demonstrate conformity with the relevant Annex I General Safety and Performance Requirements (GSPRs), suitability for intended purpose, and that the device's benefit-risk profile continues to be acceptable.

Clinical Evaluation of each medical device is summarised periodically in a Clinical Evaluation Report (CER), with the periodicity determined by the risk class of the device.

Read more about Clinical Evaluation in our guide

The challenge

Performing a Clinical Evaluation is no small undertaking. Writing MDR-compliant CERs and CEPs calls for a combination of skills and expertise, along with real proficiency when working with clinical evidence.

If that wasn't enough, it is often performed against looming submission deadlines, previous NCRs, and a changing regulatory environment.

The process of combining all the aspects of Clinical Evaluation into an MDR-compliant Clinical Evaluation Report may seem daunting. It is a formidable process which calls for a combination of skill and expertise.

We can assist you with all aspects of Clinical Evaluation including CERs, CEPs, Literature Searches & Reviews and Data Analysis.

Our core team of professional medical writers work with our specifically trained network of clinically active medical doctors, bringing the highest standards of clinical evidence appraisal and analysis.

  • Clinical Evaluation Report (CER) writing
  • Literature searches & reviews
  • Clinical data appraisal & analysis
  • Validated 14-section CER structure
  • Clinical Evaluation Plan (CEP) writing
  • Post-submission Notified Body support

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The importance of Literature Reviews in Clinical Evaluation

Well-conducted literature searches & reviews are at the heart of all successful CER submissions.

Requirements include:

  • Developing and working to a Search Protocol meeting requirements in MedDev 2.7/1 rev 4
  • Capturing all relevant evidence sources for SOTA and subject device
  • Tracking all excluded sources with justifications
  • Conducting objective appraisal of included sources
  • Extracting safety & performance benchmarks from SOTA
  • Conducting an analysis comparing evidence relating to subject device with benchmarks

The correct approach calls for a detailed understanding of the clinical field and a natural ability to work with clinical evidence.

Our unique approach provides direct access to subject matter experts who scrutinise clinical evidence in their field, alongside experienced medical writers focused 100% on Clinical Evaluation.

Learn more about Literature Reviews

Related Clinical Evaluation services

If you're not starting from scratch or would like to perform your Clinical Evaluations in-house, we also have several related services that may suit your requirements.

  • CER Review Service for Clinical Evaluation

    CER Review Service

    Already have a CER draft and need an expert review before submission? We offer a full CER Review Service incorporating line-by-line analysis, detailed revision reports and full scope recommendations.

  • NCR response and remedial work for CERs

    NCR response & remedial work

    Received a Non-Conformance Report relating to a CER submission? Our team has extensive experience in making necessary changes, re-working documents and preparing responses to Notified Bodies.

  • CER Writing Training and Template

    CER Writing Training & Template

    Learn the secrets of our successful Clinical Evaluation process and become a confident writer of CERs with our online CER Writing Training Course. This is complimented by our unique, peer-reviewed CER Template.

Contact us to discuss any of these services in more detail.

Our Clients say

  • A comprehensive, detailed and highly professional service.


    Regulatory Manager Manufacturer, UK

  • We engaged the services of Mantra Systems to support us with updating our CERs for multiple devices both for the EU & UK MDR. From start to finish the engagement and communication has been proactive and timely, keeping us updated throughout the entire process, and the quality of the reports fully met our needs.


    Head of Clinical Governance & Regulatory Affairs Manufacturer, UK

Are you looking for…

  • Clinical Evaluation consulting support?
  • A quote for our services?
  • Help understanding your options?

Whatever you need, contact us today for a free & confidential discussion.

Our Clients say

  • Regular meetings were implemented to ensure understanding of both parties and to discuss and address any findings within individual reports. We would engage the services again in the future should the need for further support arise.


    Head of Clinical Governance & Regulatory Affairs Manufacturer, UK

  • It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.


    Chief Executive Officer SaMD Company, Denmark