Market access for medical devices for Europe differs from country to country. First of all, the decisive factor is whether the target country belongs to the European Union or not. If it is an EU country, then the medical device is marketable if it has received the CE mark. If it is not an EU country, then the medical device must be approved according to the rules applicable there. It should be noted, however, that the CE mark is valid throughout the European Economic Area. Special rules apply to the United Kingdom and Switzerland, as well as to other European countries.
If the medical device is marketable, then it may be dispensed to patients and used by physicians.
Various factors are now decisive for success in market access:
How large is the market?
This question initially involves an initial assessment. How many inhabitants does the country have, how large is its gross domestic product? Experience shows that most medical technology inventors are initially interested in the five largest countries in Central Europe, Germany, France, the United Kingdom, Italy and Spain. In addition, countries that have a high level of innovation are regularly of interest.
What is the overall economic situation?
Within Europe, the level of prosperity is not the same. This is reflected in the per capita expenditure in the health sector. It is also important to consider what the economic development is like, as this also has an impact on healthcare spending.