Clinical Evaluation Report
Useful resources when writing a medical device CER
Composing the clinical evaluation report is one of the most difficult tasks you will face when preparing a medical device submission under EU MDR. Manufacturers must assess and analyse all clinical evidence relating to the subject device. You must also objectively analyse data on the clinical background, and compare alternative devices.
Due to the sheer amount of information each CER is required to cover, such documents are prone to becoming cumbersome, frequently reaching hundreds of pages. As a result, it is all too easy to become disorientated throughout the report. Understanding how to structure a CER is critical to keeping track of individual sections and ultimately the document’s success.
The MDR itself
The MDR can be a challenging document, but it is invaluable as a legislative source in CER guidance. Here is a breakdown of the most useful areas of the MDR:
Article 61 – Presenting the core rules and expectations concerning Clinical Evaluation.
Annex XIV Part A – Presenting a line-by-line top-level overview of expected contents.
Although the MDR cannot provide exhaustive guidance, the highlighted sections serve as the foundation upon which we build the other resources, so understanding them is critical. Working with the MDR has never been easier than it is now, thanks to CLIN-r+ Services.
MEDDEV 2.7/1 rev 4
The MDD commission directly composed MEDDEV 2.7/1 rev 4 and is regarded as authoritative as it is comprehensive. Its detailed coverage of the various features of performing Clinical Evaluation made it the go-to resource for CERs under the MDD.
The MEDDEV, however, is not without its flaws. Importantly, it doesn’t reflect the changes of the MDR and can be difficult to work with. As a result, it has lost some of its former clout as the all-knowing guide to Clinical Evaluation success.
MEDDEV‘s lack of language and style guidance can leave readers lost.
Whether they will update MEDDEV soon is unclear. Despite being outdated, it is an important CER tool when used with the other resources listed.
MDCG 2020-13
The Medical Device Coordination Group’s MDCG Guidelines focus primarily on specific aspects of medical device regulatory activities. These are essential for various activities, including PMCF and planning and implementing clinical investigations.
MDCG 2020-13 is of particular interest due to a template provided for a Clinical Evaluation Assessment Report. On a tangent, we could also see it as providing the ‘marking sheet’ that Notified Bodies will use for CER assessments. Therefore, consider it a great way to give a stamp of approval to existing CER drafts, and an invaluable, easy to use and free to download resource to incorporate into planning.
Other MDCG guidelines
Guidelines other than MDCG 2020-13 are offered that, provided they are relevant to your device, are worth downloading.
MDCG 2020-6 – If performing Clinical Evaluation on legacy devices is your area of interest. I.e., those previously CE-marked under the MDD, then MDCG 2020-6 has invaluable guidance specific to your needs.
MDCG 2020-5 – Extends comprehensive guidance on making a claim of equivalence.
Experienced CER Medical writers
Even with the aforementioned resources, composing a CER can be a daunting task. If you don’t have an in-house Medical Affairs team, we recommend that you outsource this expertise due to the report’s complexity. Many manufacturers turn to CLIN-r+ for medical and writing assistance. We can compile and maintain your Clinical Evaluation workflow from CEP, CER, PMCF, and SSCP.
Choosing the wrong CER template can be disastrous for the Clinical Evaluation process, even with a knowledgeable team.
EU MDR does not provide a template, so you’re strongly advised to obtain one from a reputable source. You will save both time and money by ensuring that the CER really meets the requirements.
CLIN-r+ recommendation:
- Initial planning of your EU MDR transition as early as possible is strongly advised, as is a review of the state of your MDD CER.
- In the case of any uncertainty regarding requirements, we would urge you to partner early with a Clinical Regulatory agency to fast track your insights and set them in motion.
- Reviewing all the guidance listed and considering investing in EU MDR Technical Document templates is also recommended.
CLIN-r+ offers a full clinical evaluation service, as well as templates for any section of the Technical Documentation required, including the CER. Our templates have been completely updated to reflect the most recent requirements. Get in touch!
Clinical Evaluation for Medical Devices
EU MDR how to structure your Medical Device Technical Document
