Clinical Evaluation Report templates for the EU MDR

Using a Clinical Evaluation Report template to write CERs for the Medical Device Regulation

What is a Clinical Evaluation Report template?

Using a high-quality Clinical Evaluation Report (CER) template can be a highly effective means of producing compliant CERs for medical device regulatory submissions. Following the introduction of the Medical Device Regulation (EU) 2017/745, the expected standard of CERs has never been higher, meaning guidance on content and structure can be invaluable.

Clinical Evaluation Report writing has become a very demanding and highly technical task that draws upon skills and experience that are not universally available across the medical device industry. This challenge is compounded by the fact that existing guidelines such as MedDev 2.7/1 rev 4 have not yet been updated to reflect changes to clinical evaluation imposed by the MDR. CER writers are often left feeling unsupported and unsure whether their Clinical Evaluation Reports will address all requirements.

For this reason, many manufacturers rely on a Clinical Evaluation Report template. A high-quality template can enable manufacturers to develop a CER to the required standard without needing to draw upon external expertise. Good templates will pull together information from multiple guidance sources, ensuring tight alignment with MDR requirements based on the latest advice from MDCG and other bodies.

Using a Clinical Evaluation Report template can be a cost-effective route to writing a CER. However, not all templates are equal and it is imperative that manufacturers know how to select a high-quality template that will successfully form the basis of MDR compliance.

How to choose a Clinical Evaluation Report template

Video 1: A quick guide to choosing the right Clinical Evaluation Report template

If using a Clinical Evaluation Report template, it is vital to ensure that it is comprehensive, well-structured and targeted specifically to the legislation in question (EU MDR, UK MDR, or others). Using a poor quality or malaligned template risks an unsuccessful submission and could jeopardise a device’s regulatory status.

An MDR CER template must be sufficiently flexible to accommodate the full range of requirements for Clinical Evaluation imposed by the MDR. It must be targeted specifically to MDR requirements and be structured according to the latest MDCG and MedDev guidelines. A good quality Clinical Evaluation Report template will comprehensively address all components of the clinical evaluation process, leaving the writer in no doubt what must be contained in each section.

A common problem is that writers may feel lost even while using a template, perhaps feeling unsure how to apply the guidance contained within. Example text alongside the template can be extremely useful, while access to a review service provides an additional layer of scrutiny and validation prior to submission.

Other considerations when choosing a Clinical Evaluation Report template include:

  • Annex I General Safety and Performance Requirements. The Annex I GSPRs are a comprehensive list of requirements, some (but not all) of which will relate to a particular device. Each Requirement will need a dedicated piece of evidence to demonstrate conformity. A good quality Clinical Evaluation Report template will be flexible enough to account for the huge number of possible permutations.
  • Device risk classification. Annex VIII MDR defines four risk classes of medical device - Class I, IIa, IIb and III. Clinical Evaluation needs handling differently for each risk class, meaning that a Clinical Evaluation Report template must properly address the full spectrum of requirements for all classes of device.
  • Appraisal and weighting. Included clinical evidence needs to be appraised and weighted according to a scheme set out in advance. An effective CER template will advise the writer on how to structure and implement an evidence appraisal system.
  • Vigilance and PMCF findings. An MDR requirement is to compile and clinically interpret the findings of Vigilance and Post-Market Clinical Follow-up (PMCF) systems, and to summarise this interpretation in the Clinical Evaluation Report. This process requires the writer to have sufficient clinical knowledge and acumen to perform such an interpretation.
  • The skill of the writer. The output from a template is a function of the quality of the template itself and the skill of the person applying it. Although a template has no direct control over the capabilities of the writer, careful template drafting will enable users with different capabilities and experience levels to produce CERs of a reliable and consistent standard.

What makes Clinical Evaluation under the MDR challenging?

Under the MDR, a Clinical Evaluation Report is an extensive document that incorporates and analysis clinical evidence from a wide variety of sources. Furthermore, Clinical Evaluation is unique and highly tailored to the medical device in question, meaning that example CERs involving one device cannot easily be applied to another. The MDR is structured in such a way that the Clinical Evaluation of every device will be unique.

A good-quality Clinical Evaluation Report template or example must empower the writer to solve these challenges. It must yield sufficient flexibility to capture the unique requirements of Clinical Evaluation of any individual device.

It is important to remember that Clinical Evaluation requires a high degree of clinical interpretation and evidence appraisal that no template or written document can be entirely a substitute for. A good CER template package would also include guidance on searching and appraising clinical evidence, medical writing techniques, CER review services, and access to specialist advisers.

Because a Clinical Evaluation Plan (CEP) is a core component of Clinical Evaluation under the MDR, it is also important to ensure access to a CEP template. MDR Annex XIV Part A also sets out baseline requirements for the contents of a Clinical Evaluation Plan.

What are the alternatives to using a Clinical Evaluation Report template?

Video 2: Clinical Evaluation services from Mantra Systems

A fundamental principle of successfully working with the MDR is to recognise any limitations and to work to address them directly. This applies both to medical devices themselves, and to individuals working to support regulatory approval of medical devices. Even the highest-quality template must be applied and used by an end-user, meaning there will always be a requirement for a degree of medical writing expertise.

If you are a manufacturer who looking for a high-quality Clinical Evaluation Report template, download our FREE 26-page CER template now. It adopts the structure behind our 100% Notified Body acceptance rate for CERs under the MDR and is suitable for anyone with a degree of confidence handling scientific data and performing technical writing.

Alternatively, consider engaging our professional CER writers through our 100% guaranteed CER writing service. Initial enquiries are completely confidential and conducted by one of our medical writers - we don’t employ a sales team so you’ll be straight through to a real expert.

Working directly with a professional specialist will ensure that your CERs are completed to a professional standard, meeting or exceeding all MDR requirements.

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