The digitization of notified bodies will noticeably transform the medical device ecosystem in the coming years. This article describes

  • the effects of this digitization on the notified bodies (processes, employees, business models)
  • the positive and negative consequences for medical device manufacturers and other stakeholders as well as
  • the possible steps in the digitization of notified bodies (transformation process).

If you don't have much time, then only read the chapters that are relevant to you:

  • Managers at Notified Bodies: Sections 1., 2.a), 2.c) and 4.
  • Other employees at notified bodies: Chapter 2.a) and 2.b)
  • Medical device manufacturers: Chapter 3.a) and 3.b)
1. Drivers of the digitization of notified bodies

The phase in which the Notified Bodies, as an oligopoly, were allowed to select customers and set prices and conditions is coming to an end. Because the framework conditions have changed significantly in just a few years.

Fig. 1: The drivers of the digitization of notified bodies Driver 1: Competitive pressure and increasing market power of customers

Several large venture capital firms have recognized that a multi-billion market that is no longer functional has emerged in Europe. If such dysfunctionalities can be scaled, ie eliminated with software, they will be eliminated.

The first investments have already been made. The investors have understood that it is advantageous not to found future Notified Bodies in the DACH region, but in countries that focus on the necessary requirements instead of setting up unnecessary regulatory, administrative and technological hurdles.

The unique selling propositions of future competitors are obvious:

  • A fraction of the processing and response times - thanks to digitization
  • Convenience, respectful dealings with personal "stewards"
  • Lower costs

As soon as the manufacturers with a new Notified Body can take advantage of these advantages, in particular a shorter time-to-market, they will do so. This will lead to a dam rupture.

Driver 2: Regulatory framework

The regulatory framework that has brought Notified Bodies successful years of strong growth is increasingly turning against them:

  • The MDR boom is coming to an end despite extended transition periods.
  • Political dissatisfaction with the notified bodies has grown. The first voices question the concept of privately organized notified bodies. For some products, the EMA is already taking over the competences.
  • In countries like Switzerland, products with an FDA clearance receive market approval. If this example were to catch on in European countries, the need for notified bodies would suddenly drop.
  • More and more manufacturers are deciding to start with planning approval procedures on the American market and only then to decide whether and when they will also market their products in Europe.


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