Feeling lost? Find your direction with the new IVD/MD regulations training

  • Posted on 23.08.2017

Feeling lost? Find your direction with the new IVD/MD regulations training


MedTech Europe and IVDR & MDR training: a contribution

There has been a lot of noise in the MedTech community on the recently adopted in vitro diagnostic medical devices regulation (IVDR) and the medical devices regulation (MDR). These new regulations were some 10 years in the making, yet many details still have to be clarified in secondary legislation and guidance.

Our endeavours to support the broader MedTech industry cover a wide range of topics from the regulatory environment to the field of anti-corruption compliance. And today, we cannot help but notice many different players in this microcosm organising events and trainings positioned to provide knowledge on the recently published new regulations.

Consequently, there have been legitimate questions on the responsibility and activities that MedTech Europe has in this field, and this blog aims to answer these questions.

Our members are at the centre of work we do at MedTech Europe.  In this framework, one of our key roles is to work with them in helping to understand the state of change; i.e., how these new regulations are reshaping the landscape and how they will affect medical technology companies.

In addition to own events, MedTech Europe is now in discussion with a few stakeholders to co-organise and/or support training and education on the new regulations, available to the industry in Europe and abroad (with the exception of for-profit conference organisations, which as a principle MedTech Europe does not support).

We are developing different formats including in-person trainings, webinars, contributions by MedTech Europe staff as speakers at specific conferences (e.g. The MedTech Conference), material development (e.g. flow charts which will be made available publicly) as well as our own The MedTech Forum, which includes seven different regulatory sessions, also open to any interest party.

As an example, on 7th September in Brussels, MedTech Europe is organising an in-person training aimed at explaining what Delegated and Implementing Acts are, how they are developed and how they are adopted. Concrete examples from the IVDR and MDR will form the backbone of the training. There are a few places left for non-members and will be attributed on the first come, first served basis.

Most of these activities, workshops and materials are primarily available to members only. As a Member, should you want to receive more information or if you are interested to attend these trainings such as the one mentioned above, please contact Kacper Olejniczak.

For non-members who wish to become a Member, the process is straight-forward and Christopher Breyel is the person to contact, should your company be interested.


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