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Issue II - October 2022


Improved methods for clinical investigation

and evaluation of high-risk medical devices

CORE–MD aims to translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. 

The project will be achieved through a unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies. 

The consortium is led by the European Society of Cardiology, in close partnership with EFORT, and involves 22 partners. Final recommendations will be submitted to the European Commission's Working Group on Clinical Investigation and Evaluation for consideration when developing EU guidance or common specifications.

The CORE-MD Project consists of five Work Packages. 

Where the initiative stands after 18 months

  • Work Package 1 aims at understanding the methods that have been used to generate clinical evidence for high-risk medical devices.

Comparison between the all-cause revision rates in the published literature and in the most recent registry reports is being undertaken so as to describe whether safety concerns for a specific device expressed in published studies are concordant to its real-world safety reported by registries

As regards methodologies used in published prospective clinical studies of high-risk cardiovascular medical devices the identified challenges reported by partners covered non-RCT papers which were classified as “high-risk of bias” due to poor reporting and unclear design. 

  • Work Package 2 aims at strengthening the clinical evidence for high-risk medical devices by exploring new methods for generating data about their performance.

In the field of Artificial intelligence, a guidance for the evaluation of AI and stand-alone software in medical devices is being developed. Publication of an article is underway.

CORE-MD partners are also identifying and describing methodologies and approaches used to evaluate high-risk medical devices in children and address ethical aspects of clinical evaluation in paediatric patients.

  • The main objective of Work Package 3 is to extract maximal value from medical device registries and real-world evidence.

According to partners, registries were important data sources to help manufacturers in fulfilling the MDR requirements, despite their large heterogeneity in coverage, completeness, and methods to ensure validity of data.

A mashup tool collecting clinical reports of devices has been elaborated in the framework of CORE-MD. The tool applied to few countries provides for an effective and useful approach both for notified bodies and regulators.

  • Work Package 4 and Work Package 5 will focus respectively on engagement with stakeholders, and project management.

The preliminary results from the interviews showed that the focus should be on academic curriculum for all stakeholder groups rather than a single Master on Regulatory Affairs with specific attention on methodology of clinical evaluation. 

EFORT e-learning

Save the date for the upcoming EFORT Industry Collaborative Webinar (ICW)

On Tuesday 15 November at 12:30 CET, the EFORT Industry Collaborative Webinar with Mathys Medical will focus on The Isoelastic RM Cup: More than 40 Years of Clinical Experience.

The objectives of the webinar are:

  • Concept of the isoelastic RM monobloc cup
  • Indications of RM cup in primary and revision surgery
  • Technical aspects of implanting the RM Cup

This Industry Collaborative Webinar is organised with the support of Mathys in collaboration with EFORT.

eScience Webcast highlights

This month's selection from EFORT comprehensive digital library

comprised of +11,500 scientific sessions recorded




Spine Deformities

In The Childhood

by Muharrem Yazici

FORTE Session Knee 

Back To Basics 

Bone Trauma

About The Knee

by Jasmin Diallo




Study Design

And Statistics

by Andrew Judge


Industry O&T Product News

Sponsored ad*

*This section provides news, offers and an overview of orthopaedic & traumatology-related products in form of paid advertisement plans. We believe the information to be accurate, timely and qualitatively high enough to interest the orthopaedic and traumatology community, however due to the fact that we rely on information provided by external sources we are not in a position to make any warranty or guarantee concerning the accuracy or reliability of the content at this site or other sites to which we link. Hence their scientific content is not necessarily endorsed by EFORT, unless stated otherwise.


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