Clinical Evaluation Report templates for the EU MDR

What is a Clinical Evaluation Report template?

A Clinical Evaluation Report (CER) is a complex technical document that summarises the process of Clinical Evaluation, a component of all medical device regulatory submissions under the MDR. The introduction of the Medical Device Regulation (EU) 2017/745, means that Clinical Evaluation Report writing will need to be completed to a higher standard than before.

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, example, or sample. 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 official advice.

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

If using a Clinical Evaluation Report template, it is vital to ensure that it is comprehensive, well-structured and targeted specifically to the EU MDR. Using a poor quality template could jeopardise a device’s regulatory status.

A 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. A really effective template will include example text in written prose, allowing the template user to see exactly how to apply the template to their devices.

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 is markedly different in each risk class, meaning that a Clinical Evaluation Report template or example must properly address the unique requirements for each individual risk class.
• Unique clinical evidence portfolios. The clinical evidence portfolio for one device will seldom be similar to that of another. An effective Clinical Evaluation Report template must enable a writer to draft an accurate summary of every individual piece of clinical evidence, as required by MDR.
• 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, a CER template should also include guidance on developing and writing a Clinical Evaluation Plan.

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

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 is unsure whether to rely on a Clinical Evaluation Report template, it could be highly beneficial to seek advice from specialist service providers who will ensure that your CERs are produced to the required standard. Mantra Systems offer a free and confidental consultation where a member of our team would be delighted to discuss your requirements.

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