Best foot forward – Pros and cons of entering the EU market first

by | Jun 25, 2024 | EU, IMed Consultancy, MDR, New Markets

New markets - Mexico

Welcome back to our new blog series dedicated to International Market Entry!

IMed’s team will look at three major markets for medical devices- the EU, the UK and the USA- highlighting some key considerations relating to entering each of these geographies “first” to help manufacturers make informed decisions and successfully expand the global presence of their products.

In our previous blogs we covered the current global regulatory scenario and its opportunities, the US market and the UK one.

This final instalment will focus on the European medical devices market.

The European medical device market

While the US is the biggest world market with 43,5% share of medical device sales, the European Union trade bloc follows with 24.5%, making this an appealing market to launch your medical device.[i]  

Route to market in the EU

In the EU a medical device manufacturer of medium risk devices faces quite a complex and long journey towards approval, compared with entering the US market under 510(k). Specifically, in the EU the medical device manufacturer needs to build up a larger body of evidence and create a technical file dossier. They also need to find a Notified Body to certify their products, evaluate their QMS, review their technical documentation and particularly their clinical evidence.

Notified Body capacity issues are of particular concern with many close to reaching a bottleneck in their activities and not accepting new manufacturers, or requiring lengthy pre-assessment wait periods to begin the technical assessments needed for approval. The European Commission (EC) has taken new measures to relieve some of the pressure on Notified Bodies by reassessing the frequency of with which they have to face reassessment by Competent Authorities and the EC.[ii] The 38 existing Notified Bodies are responsible for having issued 1,990 of the 8,120 applications received as of October 2022 according to BSI, leaving a majority of devices still to transition to the EU MDR by 26th May 2024.[iii]In particular, Notified Body bandwidth is occupied with this transition making it difficult for businesses wanting to propose product changes, reclassify devices and for businesses with new products looking for a NB willing to take them on.

PROs & CONs of pacing a device on the EU market

In Europe, like elsewhere, the risk class of the device is going to determine how much financial and staff effort, as well as how much time is required to get the product onto the market. However, with the current climate of uncertainty and lack of NB bandwidth, more and more businesses are choosing not to be present or delay entry to the European Union market.

In addition to linguistic fragmentation that raises costs for labelling and marketing materials (often calling for specialist medical translators) there are also regional legislative differences within each country: example, Germany has very restrictive regulations about medical device pricing. Regional, provincial and other institutions may also have a say in pricing decisions depending on where the medical device is to be sold.

On the other hand, the EU commission has clearly acknowledged that there are issues and is working on addressing these to make the EU a more attractive market and ensure that patients are not put at risk by a lack of new, innovative and existing medical devices. As a result, there are various measures in the works to help make the transition from earlier regulation to the EU MDR/IVDR less complex. The recent extension of deadlines for implementation is one such measure for existing products certified to older regulations.

It is also worth noting that although CE Marking may take more time and result a little more complex, the CE Mark is one of the certifications that is most widely accepted in other territories. It is often more powerful as a mark than FDA approval and is particularly effective in speeding up market access in the Middle East, Africa and ex Commonwealth nations. Manufacturers that want to scale up fast and export their products globally would therefore do well to consider gaining EU certification before any other.

Choosing the right market for your medical device

In this complex environment it is hardly surprising that medical device manufacturers with new devices, or that want to expand into new territories, are confused. Costs, timelines, shifting deadlines and potential extensions, these are all elements of uncertainty that make the decision regarding market entry, and particularly which market to enter first, highly complex.

There is of course no clear-cut answer for medical device manufacturers evaluating which market to enter first, but understanding the strengths and weaknesses of the regulatory systems currently active in these major markets can help frame the decision-making process.

Without a doubt, device maturity, therapeutic area and classification will drive the selection of the market most likely to yield success, but venturing forth without experienced guidance and advice means taking unnecessary risks in what is currently a changing and complex regulatory landscape.

The importance of relying on international regulatory experts

Securing the support of international regulatory experts will not only help navigate the complexities of specific markets, managing the expectations of their authorities efficiently and rapidly, but can help identify areas of overlap between the different geographies’ requirements to help structure longer term expansion strategies.

Read more about it on our white paper, available on our Resources page, or contact the team at IMed Consultancy for deeper insight into the UK, US and EU regulatory scenarios:

[i] MedTech Europe, The European Medical Technology in Figures, Market (Last update 19.09.2022)

[ii] Official Journal of The European Union, Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of Notified Bodies

[iii]BSI, Will the EU Medical Devices Regulations certificate cliff edge in 2024 be avoided?

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