Complex approval processes and high cost are among the challenges causing US medical device manufacturers to question whether the European Union Medical Device Regulations (EU MDR) are worth the time, effort, and expense.

To put the pros and cons into perspective and offer potential solutions for US manufacturers who choose to remain in the potentially less crowded EU marketplace, Leeanne Baker, managing director and senior quality assurance and regulatory affairs consultant at IMed Consultancy, will lead the Should I Stay or Should I Go? The Silver Lining of Sticking Around After EU MDR panel discussion at Advanced Manufacturing Minneapolis (MD&M), October 16 and 17.

The numbers

More than eight in 10 companies say the time it takes to secure permits is a barrier to investing in Europe, according to a BusinessEurope survey and subsequent article by Reuters. More than 80% of 240 companies surveyed reported the complexity and duration are obstacles to investing in Europe, and more than half called the permitting process a serious problem.

The European medical device market makes up an estimated 26.1% of the world market and is the second largest market for medical devices after the US, at 47.2% market share. Globally, in vitro diagnostics (IVD) is the largest sector, with cardiology and diagnostic imaging second and third, according to MedTech Europe.

MD+DI talked with Baker prior to MD&M Minneapolis to discuss the pros and cons.

What are you hearing from companies in the US about EU MDR process problems?

Baker: Across the board — not just the US — there has been so much uncertainty with deadlines changing. [That’s] coupled with the fact that there is such a big increase in the level of information required — the detail in key areas that companies now need to provide. Clinical evidence is a big one.

Additional cost has been one of the biggest barriers that we’ve seen. Our clients, for example, often face the issue of translation. If you’re going into the EU market you potentially have 27 translations that you have to do on all your labelling and artwork [which] could be quite costly. In addition to this, they will need to be adding [unique device identifier] UDI codes and information.

The other thing we’re finding with established companies is that, especially with products that have been on the market for quite some time, there are gaps in information or history that they then need to go back and fill. They’re having to provide more evidence to support performance claims in their intended use.

And in the EU, a medical device manufacturer needs to find a Notified Body [designated by an EU member state to assess products’ conformity] to certify its products.

Are these issues primarily impacting medical device companies?

Baker: We do see it with IVD companies and the new IVDR regulations. To be honest, there are some companies on their journey to full compliance and working toward the transition, while other companies haven’t even started. I think that’s because of a potential lack of knowledge and awareness as the majority of the CE marking for IVDs under the IVD directive did not require Notified Body review. So, for some it’s going to be a big learning curve for them, with a lot of last-minute panicking.

From your perspective, what is the most important for US medical device manufacturers to know?

Baker: Companies had a tendency to consider the regulation in isolation. Now, it’s all linked with the commercial strategy of the business.

We work with quite a lot of SMEs and SMOs. We start out by asking: ‘What are your target markets and users? What priorities do these fall into? What is the minimum viable product?’ Then, we can build a regulatory strategy that links into the company’s commercial strategy, which covers topics such as cost, timescale, and resources needed.

The good thing about the EU is companies can use it as a steppingstone into other markets — the Middle East, Africa, India, and others. Having the EU CE marking simplifies and expedites the process of getting into those other countries.

Some medical devices are more challenging to get through in the EU, and that’s based on risk classification. The higher the risk classification of your product, the more difficult and challenging it’s going to be to get into any market, but that’s particularly true with the EU.

The difference between the US market and EU is the majority of devices in the US go through the 510(k) clearance process. You’re claiming substantial equivalence, and the clinical requirements are different — in some cases reduced. That tends to create a big gap in both evidence and documentation, especially as the EU requires a Technical Documentation File.

Companies need to plan ahead if they start the EU MDR process. If they know they have a lot of lead time for Notified Body review, companies should ask these questions: ‘What evidence do we need? What gaps need to be filled? What additional clinical evidence can we start gathering post market US?’

Our advice to companies is to always start sooner and be realistic about review times with Notified Bodies. There is no such thing as too much planning, even if you think you’ve got a number of years before the deadline to get through on EU MDR.

Another pro is that, at the moment, the UK accepts the CE mark. You don’t have to go through the UKCA process to be able to place your device on the UK market. We act as a UKRP for those clients wanting to place their devices on the UK market.

Are there strategies that companies should consider when deciding on whether or not to pursue EU MDR?

Baker: A lot of manufacturers, especially bigger organizations, have streamlined their portfolios. As a result, some have withdrawn products from the EU market as part of their ongoing commercial strategy balancing the cost of compliance with regulation and the sales and pricing they are achieving. Some countries, like Germany for example, have specific pricing lists for certain products, which restricts profitability for certain businesses. They’ll spend their time and resources on the products that they sell more of and make more money.

That presents a commercial opportunity for other manufacturers.

After the US, the EU remains one of the largest markets globally and as such offers an intrinsic reputational value for a company to be able to place devices on the market and take advantage of the commercial opportunity.

What are the first steps for a smoother EU MDR process?

Baker: Look at what information you have, assess what you’re going to need and what’s missing, and plan ahead with the time available.

Inactivity is the biggest risk. Speak to an international regulatory expert as early as possible.

Article source: MDDI