How to fill the gaps of clinical evidence to comply with the Medical Device Regulation (EU) MDR 2017/745

In-company training in CE, PMS and PMCF (NL - EN)

Ga hier voor maatwerk op jouw mensen of organisatie. We helpen je snel verder.

Prior knowledge of MDR and MD clinical evaluation and investigation required

Learn how to perform a gap analysis on the clinical evidence

The MDR rules out stricter requirements for clinical data, and its acceptability as clinical evidence needs to be analyzed, specified and justified.

Currently the MDR requires MD companies to comply with strict requirements when performing Clinical Evaluations, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF).

During this online training all above will be explained in order for the participants to understand the clinical needs, and to analyze and fill the gaps in clinical evidence.



After these virtual trainings, you are able to understand and apply:

  • Fully understand how the MDR has an impact on clinical requirements. 
  • Understand the need for well-planned and -established CE, PMS & PMCF.
  • Analyze gaps in clinical evidence & know how these gaps can be filled.



This live online training is divided into two sessions of three hours each in which the expert theory alternates with interactive discussions and cases. Following topics are covered:

  • The impact of the MDR on clinical requirements
  • Clinical Evaluation, PMS & PMCF activities
  • What is Clinical data & Clinical evidence?
  • How to perform a gap analysis?

Because of the international (EU) aspect, this English-taught virtual course offers the opportunity to easily participate from other EU countries as well.



Target audience

MD professionals from the industry (manufacturers, suppliers, subcontractors and stakeholders)

  • Clinical Affairs
  • Regulatory Affairs
  • Quality Managers
  • Clinical Project Managers

Prior knowledge 

Background on MD clinical evaluation and investigation. Having knowledge of the MDR.
Literature will be provided as preparation for the course.

Jouw coaches

Karen Gabriels

Expert – Clinical Research Manager

Meer over Karen

Mieke Tempels

Expert – Clinical Research Professional

Meer over Mieke

Praktische informatie


Voor bedrijfsinterne projecten verwijzen we naar de algemene voorwaarden en de voorwaarden in de aangeboden offerte.

Nog vragen?

Heb je een vraag over deze opleiding? Wij helpen je graag verder! Neem gerust contact op met ons.


Vraag offerte aan

Laat hier van je horen. We helpen je snel verder.

Schrijf je in voor de Allanta nieuwsbrief! Ik ben geïnteresseerd in:
General Manufacturing & Services

Met (*) gemarkeerde velden zijn verplicht.