Medical Devices Regulation (MDR) – current situation and directions

The European Union’s new Medical Devices Regulation (MDR), which replaces a more then a decades-old legislation, came into full effect.

As a result, device manufacturers can expect

  • higher costs
  • longer timelines for developing new products
  • expensive new clinical monitoring and evidence generation to recertify many existing products.

This is deeply affecting business models of all medical and diagnostic device companies.

The new regulation has also created a challenging situation for Notified Bodies:

  • all NB’s needed to become re-assigned to the new regulation, which demanded elevated resources and other cost related requisites.
  • many smaller NB’s just ceased their activity in the area of MDR, resulting in a lack of NB’s willing to receive new customers.

On the other hand, manufacturers realized that the lack of continuous collection of real clinical data about certain products in the past will require performing Clinical studies for those products to be able to provide reliable clinical data for the MDR certification process.

Preparing, managing and handling a PMCF of a full clinical study is among the most challenging situations right now for the manufacturers.

With our webinar we would like to provide you with

  • a clear and comprehensive picture about the current situation,
  • a description of changes and challenges faced by manufacturers under the new EU regulations,
  • a presentation of how our services will ensure compliance which can lead to maximum success.

The webinar will also give you details about the current situation in regards to the MDR:

  • how the transition is going since 2021 May
  • the most important changes affecting the manufacturers
  • where are the pitfalls and bottlenecks
  • what kind of studies can be performed
  • how HungaroTrial can help during this period to obtain the CE mark

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