Medical Devices Market in EU: Dos and Don'ts

Last updated: 28 September 2023


For most medical device manufacturers, expanding to Europe is expected to grow sales by at least 20%. But it is more complicated than putting something on the internet or giving something to the distributor and getting international shipping packages from point A to B.

Is your company up to the daunting task of expanding to a whole new market? Here are some things you should take into consideration as you craft your next move into the European medical devices market.


Do Not Underestimate Medical Devices Market in Europe


If you decide to enter any new European market, be aware that mistakes might happen when you do not research enough. While some of the manufacturers are still confused about whether Europe is one country or whether the European regulations would work for the entire of Europe, it is important to carry out research to know which rule applies to which country, which language is spoken in which countries, and which kind of products are expected to sell in some countries.

Do not spend too much money experimenting, make sure you know what you want to sell from country to country, and often rely on your market research before you come to conclusions.

Get the Right Partner for Your Medical Devices


While retail products might require fewer difficulties in partnerships, medical devices in Europe require an extensive chain of partners, ranging from distributors to hospitals, pharmacies, regulators, and many others. If you expect to expand in the European medical device market, it is important to be aware that you will need to get a notified body (should reside in the country of export).

For other partnerships, it is always important to reach out to companies like EuroDev that can offer you extensive services in the line of managing your employees in Europe, Sales Outsourcing, or Digital Marketing services.

Read more: EU Medical Devices Regulations – Unique Device Identifier (UDI)


Learn from the Medical Devices Market Challenges


While medical device manufacturers have a specific solution for why it was manufactured, it is important to further understand the market demographics, the challenges that might be involved in selling a specific device, the challenges that are involved when your consumers are trying to buy the product and many others.

Further, as a manufacturer of the product, you should also understand that you might face some challenges when entering the European medical device market. These might not be limited to regulations but also the language barrier, cultural differences, technological differences, and many others.


Do Not Mistake One Country to Be Similar to Another in the EU Medical Devices Market


Expansion in Europe must require different regulations besides those implemented by the European Union. Every country has its regulations, and you must educate yourself about how these countries work.

Further, even though you should create a replicable strategy for Europe, it is important to understand that Europe is made up of different cultures, different languages, politics, and many others. Hence, the strategy has to be edited to ensure it fits a specific country.

Read more: Entering the European Digital Healthcare Market


Always Be Ready For Disappointments


What might work in the USA might not work in Europe. In Europe, hospitals, distributors, and pharmacies will always turn to the USA to buy the products they cannot get within Europe. In the USA, most medical device manufacturers would assume that free shipping is always a given. Hence, will not be able to use that as a differentiator with European buyers.

In Europe, there is no free shipping between Europe and the USA. Customs in Europe will always want their import duties and taxes – making shipping a long, expensive, and painful process with a surprise behind every door. For a new European buyer, it might disappoint them when going through all these challenges while trying to import your product into the region.




It is important to understand that after assessing the market conditions that are likely to impact your market entry strategies, you will need to understand the challenges that you might face as they turn from domestic to European markets. Here is a checklist of all the ways to beat the heat when it comes to transitioning to the European medical device sector:

  • Consider the different partner platforms based on your product lines, market
    and competitors in the market. For instance, pharmaceutical products might
    require different platforms from surgical equipment.

  • On top of understanding the right platforms for your devices or products,
    also find the right partner and market your products. This is in line with
    getting a partnership with a localization expert to help you ensure that your
    messages are rightly aligned with the needs of your customers.

  • Focus on products that are niche so that you stand out from all other
    products and competition. This can increase demand creation and limit
    crowded markets.

  • To be successful in Europe, consider paying attention to the small details like
    changing your website domain from a .com to a “.uk” or “.eu” or “.de” to
    make the European market more comfortable with your website and
    accessing your products.


Let's discuss how we can assist your expansion in the European medical devices market. Check out our proven Sales Outsourcing services.

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