Regulations and Guidelines in Medical Device Trials


ICH GCP R2, ISO 14155, EU Medical Device Regulation instead of Directives and MEDDEV guidelines all provide either guidance on or regulate the medical device research field. European organizations like EUCOMED and MedTech represent the medical device business to ensure regulatory compliance and increase the European competitiveness with other global regions. All this information can cause the device researcher to wonder what to follow and when and how to ensure compliance.

This TRIUM Training provides clarity by explaining the differences between guidelines, directives, standards, requirements and regulations and by providing an update on the key sponsor and investigator responsibilities. Lecture is held to a minimum, instead many opportunities for sharing ideas, examples and case studies are built into the design to ensure peer to peer learning and knowledge retention. Therefore, participants will not only be able to repeat what they learned but will also be able to find information when needed and apply it immediately to ensure trial oversight, compliance and audit readiness at any time for themselves and their business partners like vendors or consultants.

At the end, you will receive a certificate for attendance and handy hand-outs for use in the field.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Describe the difference between a guideline/guidance document, standards, requirements (e.g. ISO) and a regulation
  • List the sponsor and investigator responsibilities as per ICH GCP R2, ISO 14155, the European Directives/MEDDEV guidelines (2.7.1 rev4) and the EU Medical Device Regulation
  • List the EUCOMED device trial related requirements
  • Find the device related guidelines and regulations by using the official regulatory body website of the EMA or ISO and by using the EUCOMED/MedTech/MEDDEV websites
  • Ensure trial oversight for the sponsor and its business partners to ensure compliance and audit readiness at any time
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Esther Daemen
Esther Daemen has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”