Simplifying Clinical Evaluation Report Preparation as per new EU MDR

Hundreds of thousands of medical devices are manufactured annually across the globe with the intention of providing assistance to those who are struggling with their health. Manufacturers of these devices are supposed to take extra care in the production process. But sometimes due to shortcomings in design, certain errors happen and those people who use or interact with these erratic devices can lead their health and lives at risks.

This blog discusses the importance of Clinical Evaluation and debunks certain myths and misconceptions encircling this topic in the light of European Union’s new Medical Device Regulations. These regulations were proposed in 2017 an EU parliament accepted it the same year.

Before MDR, Medical Devices Directives (also known as MDD) was imposed throughout the Union. Transition from MDD to MDR brought many significant changes, such as in definitions, requirements of clinical evaluations itself and different other changes.

MDD to MDR; What’s New?

In MDD, there wasn’t any significant definition provided regarding the definition of clinical evaluation. MDR covers it in the following manner:

A clinical evaluation is a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits of the device when used as intended by the manufacturer.

EU MDR

It is thought that in order to confirm requirements of conformity, following requirements of sections 1, 3 and 6 of Annex I and those of Annex X will be enough but, this is not the case. New MDR has increased requirements of clinical evaluations dramatically.

The definition regarding clinical data in MDD was

“Clinical data is the safety/performance information generated from the use of a device.”

EU MDD

Requirements regarding clinical data collection according to MDD were limited to:

  • Clinical investigation of particular device
  • Other investigation present in scientific literature regarding the same device or any equivalent device
  • Any reports published regarding the same device or equivalent device in a scientific journal which is popular among general public and
  • Clinically relevant information coming from post-market surveillance

Now one can examine the definition and requirements proposed in MDD were way too precise than the MDR and did not significantly cover all the areas necessary in this scope. MDR however, came up with a concise yet well-defined and elaborated version regarding clinical performance and clinical benefits.

 MDR’s Definition Regarding Clinical Performance:

“Clinical performance is the ability of a device, resulting from any direct or indirect medical effects which stems from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer.”

EU MDR

For clinical benefits, MDR states

“Clinical benefit is the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health.”    

EU MDR

Hence it can be said that confirming only the old requirements will not be enough as new, MDR demands more from the manufacturers.

Is there any Difference Between Clinical Data and Clinical Evidence?

The difference between clinical data and clinical evidence seems confusing. Clinical Evaluation Reports which consist of data but what lacks in them is data’s context. It should be noted that an information without its context is not valuable as compared to the information which carries a proper context with it. What experts want with from companies that while preparing a CER, they should remember to add that information which is serving as basis of their data. In this way, they will be able to adhere with the conformity requirements of General Safety and Performance Requirements section 1 and section 8. Thus it should be clear, that in order to come up with a better Clinical Evaluation Report, there should be all the data as well as the information which led to formation of that data.

What Is Clinical Data According To MDD?

According to EU MDD and EU MDR, clinical data is defined as

“Safety and/or performance information generated from use of device.”

EU MDD / EU MDR

According to MDD, sources for collection of clinical data include clinical investigation of that particular device, clinical investigations or other studies regarding a similar or equivalent device or any published or unpublished report rewarding clinical experience of regarding a similar device or equivalent device. This is how clinical data is defined by the MDD.

Whilst MDR states the same while defining Clinical Data but it comes with greater amount of requirements regarding source of Clinic Data. They include clinical investigation of particular device, clinical investigations or other studies published about the same device or equivalent device in any scientific literature or other clinical literature, in any literature which is peer reviewed and clinically relevant information coming after post-market surveillance.

It is quite obvious from upper mentioned requirements of MDR that reports regarding post-market surveillance of a medical device must be made part of the clinical data. Post-market surveillance has been greatly emphasized in new MDR.

Establishment of State-of-the-Art

State of the art is the best practices which are utilized in other medical devices of the same or similar type. This is yet another important step required in Clinical Evaluation process. Establishment of State of the Art for the disease regarding which the device is manufactured, and is intended to treat, monitor or diagnose the disease. 

Establishing State of Art requires following:

  • Information regarding use of the device in general population
  • Opinions and concerns of experts and professionals
  • Any requirements of technology, or advancement that device is missing
  • Any clinical hazards which can be risk for general population (in particularly with the elder, children and pregnant women).

TS Q & E can help Companies and Professionals Struggling for CER

It will be difficult for many companies to manage various functions for their company and dedicate or employ an expert to write a CER for their medical devices as per new EU MDR. Or professionals will face difficulties in writing the Clinical evaluation report themselves, because it includes literature research and fulfilling other various requirements.

TS Q & E has therefore employed experts of CER report and literature research, who can do the extensive research and clinical evaluation report compilation work for companies. Moreover professionals who want to understand comprehensively the new requirements of EU MDR on clinical evaluation, can request our clinical evaluation training programs. Please send your inquiries through our Contact Us page.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.

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