Clinical Evaluation Report Requirements Under MDR

Regulation (EU) 2017/745 has expanded the requirements related to Clinical Evaluation and Clinical Investigations with Chapter VI (Articles 61 to 82) covering this area.  We take a look at the clinical evaluation report requirements under the MDR to be introduced in May 2021.

Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application.  The date of MDR application has moved to May 26th, 2021.  Articles that were written prior to the delay referenced the earlier date.  However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration.  Read more here.

Does A Device Require A Clinical Evaluation Report?

The new MDR requires all Classes of medical devices to have a Clinical Evaluation Report (CER). In addition, MEDED 2.7/1 rev. 4 Clinical Evaluation: A guide for manufacturers and Notified Bodies’ has tightened the process for Clinical evaluation. 

MDR Article 61 and Annex XIV outline the requirements of clinical evaluations. In summary, clinical evaluation comprises of a review of relevant scientific literature of the device (provided that the device under evaluation is equivalent to the device to which the data relate); a review of all available clinical investigations data (data generated by the device under evaluation and/or published data); and also considering any current alternative treatment options with the same purpose. 

It is also important to note that, MEDED 2.7/1 rev. 4 ‘Clinical Evaluation: A guide for manufacturers and Notified Bodies’ has tightened the process for Clinical evaluation and while this guidance is specific to MDD 94/42/EEC, it should be considered along with MDR requirements. 

Compiling A CER

While Article 61 (4) MDR indicates that Class III devices and Implantable devices require a Clinical Investigation with exceptions as per Article 61 (4) and (6) – it transpires that for all other devices, MDR’s strict requirements regarding demonstrating equivalency between devices under evaluation and comparator devices, make the compilation of a CER quite a challenging task.  

Furthermore, in the CER, if the comparator device is a competitor device, then for Class III/Implantable devicesit must be demonstrated that there is full access to the competitor device’s technical documentation – this may necessitate a contract between the manufacturer and that of the competitor device. 

Equivalence (between devices) falls under Biological, Clinical and Technical criteria. Criteria for Biological and Clinical equivalency are given in MEDDEV 2.7/1 rev. 4while technical criteria are broader and must be chosen with regard to the device under evaluation. 

On assessment, the Notified Body will question any differences between the device under evaluation and the comparator device from the point of view of clinical safety and performance requirements as established for the main device. 

The Need for Clinical Investigations

If Clinical Investigations are required, then the requirements are outlined in Articles 62-82 and Annex XV of the MDR. 

Following on from Clinical Evaluation, Annex XIV Part B of the MDR, indicates the requirement for a PMCF process for all medical devices. If manufacturers do not have a PCMF study, they must adequately justify this.  

PCMF studies should have a PCMF Evaluation report that should be used to update the CER throughout the lifetime of the device. 

Since the timeline for Implementation of MDR is fast approaching, it is important that device manufacturers are ready for the new requirements of Clinical Evaluation. 

Steps To Consider For An MDR Compliant CER

This includes: 

  • identifying company procedures and documents that concern clinical data   
  • Conducting a gap analysis between current company procedures and documents vs MDR requirements and implementing any updates needed 
  • Noting differences in definitions between current MDD and guidances vs MDR and addressing these in current company procedures 
  • For new devices to be CE marked, planning now for Clinical data requirements 
  • For legacy devicesdevising a Clinical data policy 

Are you ready for the new requirements under MDR 2017/245? 

We can help you to prepare for the May 2020 deadline.  Call us today on 00353 52 61 76 706 or complete the form below and we will get back to you.

Further Reading from Acorn Regulatory

What Are Post-Marketing Surveillance Studies?

Post-marketing surveillance studies are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures.  In this article, our Medical Manager, Dr. Danica Cvetkovic, looks at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s)

Read the article here.

Understanding MDR: 8 Important Changes

The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector.  The new regulations will bring about many changes compared to the current regulatory framework.  We look at the basics of the new MDR and the changes that will impact the device sector from May 26th, 2020. Read the full article here.

Need A WDA? Read Our Step By Step Guide

There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years.  We have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining a WDA.  Read the full article here.

How To Prepare For A Pharmacovigilance Inspection

A pharmacovigilance inspection can be a daunting prospect for many companies.  Since 2002 we have worked with countless companies to guide them through their inspections. We look at the measures that your company can take to be prepared.  Read the full article here.

How To Complete A Type I Variation

Type I Variations to a Marketing Authorisation are surprisingly difficult.  The procedure that many people perceive to be a simple process can prove to be otherwise.  This article looks at how to complete a type 1 variation and we will consider:

  • common deficiencies
  • common validation issues
  • the challenges posed by the eAF
  • what to do when documentation is missing
  • how to handle GMP variations
  • what happens when a CEP is presented for an active substance instead of a GMP certificate

After reading this article you will be better placed to complete a Type I Variation to a Marketing Authorisation while avoiding the common pitfalls outlined below.  Read the full article here.

What Are The Initial Steps in Applying for a Marketing Authorisation?

We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA).  In this article, we aim to provide a guide to assist companies applying for an MA

We have also provided a number of links throughout the article to relevant articles, authorities, organisations, and pieces of legislation to assist you.  Read the full article here.

About the Authors
Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance.
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Bronwyn Kelly
Senior Regulatory Affairs Advisor - Medical Devices
Bronwyn Kelly is a Senior Regulatory Affairs Advisor in our growing medical devices team. She has a wealth of experience in both device and pharmaceutical regulatory affairs and she has worked with some of the world's biggest companies in both sectors, In her current role she works with device clients on issues such as EU Authorised Representative and PRRC (Person Responsible for Regulatory Compliance) related issues.
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