The new medical device directive in EU – an opportunity for Sweden?

This report refers to a study of how Swedish companies, representatives of industry, authorities and regulatory consultants regard the introduction of new EU regulations concerning medical devices. The study looks at what measures the companies apply in order to conform and what support they need from authorities and other players. It has also investigated what action the authorities concerned in Denmark, the Netherlands and Ger­many are planning to take to promote innovation.

The overarching aim of the study is to contribute to the creation of good basic preconditions for innovation and growth at Swe­dish medical device and IVD companies when the new regulatory framework comes into effect.

Increased costs and reduced innovation pace

Companies believe that adapting to the new regulatory framework will involve higher costs, related among other things to changes in classification rules, more stringent require­ments concerning documentation and clinical studies, and access regulatory competence. This may eventually lead to both more expensive products and existing products being discontinued, which in turn will impact on the health and medical care services and ulti­mately the patients. There is also a fear that the companies’ work on product development and innovation may be affected detrimentally by the stricter requirements and the limited availability of notified bodies. Clinical studies may also come to be conducted in non-European countries to a greater degree.

Need for information and competence

It is clear that a great many of the medical device companies and IVD companies will need to do a great deal of work to adapt to the new regulations. The study indicates that small and medium-size companies in particular have widely varying knowledge about the new regulatory framework and what the changes might involve for them. Most of the com­panies interviewed have hitherto not taken any extensive action as a result of the new regulations but are waiting until they come into effect.

The companies want more information and clarification of the wording of the new regu­lations and several of them say that they need to strengthen their competence in the regu­latory area, which can be accomplished through competence development and recruitment and engaging consultants. One obstacle that emerges in this context, however, is the limi­ted number of people who have both the appropriate training and sufficient experience of the regulatory area in Sweden.

The companies are also looking for support, primarily from the Medical Products Agency. Information is needed about what changes the new regulatory framework will involve and how it is to be interpreted, as well as provision of advice and practical assistance, for example by means of guidance documents and checklists. The health and medical care services should also be informed about the new regulatory framework and what it means for their activities.

Other countries have started to take action

It emerged during the course of the interviews with the players concerned in Denmark, the Netherlands and Germany that some preparatory work has begun and that at this stage these mainly relate to different ways of informing companies and other concerned players of the coming changes. However, it is not possible at this early stage to describe what innovation-promoting measures the authorities will take.


The study makes a number of recommendations concerning issues and areas that it can be important to focus on as the work proceeds.

  • Access to regulatory competence regarding the new regulatory framework is a cri­tical factor and the question of how regulatory competence can be strengthened not only at the companies but also within the health and medical services, authorities that support innovation, incubators, testbed activities, and players who conduct clinical studies should continue to be analysed. Against this background, there is reason to review how competence provision measures should be designed.
  • There is a clear risk that many companies will wait until the last minute to adapt to the new regulatory framework and that this will overload the system. To avoid this, ways to create incentives for companies to plan and implement changes in time should be studied more closely. One of these might be to inform the compa­nies of the costs and create economic incentives.
  • A possible shortage of notified bodies in Sweden may be a bottleneck that both increases the companies’ costs and lengthens development times. Such a scenario is believed to mainly affect small businesses. An analysis should be made of the notified bodies’ prerequisites and abilities in Sweden.
  • The study elucidates innovation-promoting measures by authorities in a few other European countries. As the work continues, the development of the regulatory environments should also be monitored in other markets, for example the USA, Japan and China, where such development can have an impact on where compa­nies choose to introduce their products first and conduct clinical studies.
  • The study shows that there is great uncertainty about what the new regulatory framework will come to mean, which is hardly surprising since it has not yet come into effect. However, a follow-up of the study in approximately two years’ time might be justified to see how companies and authorities are faring.

The new medical device directive in EU – an opportunity for Sweden?

Serial number: Direct response 2016:28

Reference number: 2016/197

Download the report in Swedish Pdf, 805 kB.


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