Copy to clipboard 
So, you want to launch a product in Europe? You might want to reconsider your strategy. The regulatory tables have turned, and it now takes a lot more time, money and energy to launch an orthopedic product in the EU market.
Pursuing a CE Mark will not be the right choice for every orthopedic manufacturer. Only companies with deep pockets, patience and alternative revenue sources will survive the complex and expensive Medical Device Regulation (MDR) certification process.
Recently, the U.S. had the reputation of being the more difficult entry point for new products due to FDA’s extensive data requirements. Europe focused on performance standards, naturally becoming the obvious choice for initial market entry. But the EU MDR has ushered in a significant paradigm shift that has made the business case for the European market a lot less promising.
There are several reasons for this shift. In 2018, FDA set a strategic initiative to become the regulatory agency of choice for companies looking to bring products to market first or in parallel with other major markets. Further complicating things is the uncertain political climate in Europe. It’s a bit of a mess, with 27 EU member states, four European Free Trade Association (EFTA) countries, a lapsed Mutual Recognition Agreement (MRA) with Switzerland, and a Brexit deal that took the UK out of the whole arrangement.
This changeable situation has brought far less harmonization than initially intended. The original MDR was written in English, then translated into 24 different languages, with much being lost in the conversion to regional dialects. As a result, each Notified Body interprets the regulations slightly differently. Add in the cultural distinctions from country to country, the differences in application and submission processes, fees, the Notified Bodies’ opinion on audits, and their individual processes and areas of expertise. You’ve got legislation that has indeed become more interpretation than law.
MDR also introduced an increased emphasis on postmarket activities that are exponentially greater than what they were under the Medical Device Directive (MDD) – and certainly above FDA expectations. But it is the processes themselves that have made MDR certification a nightmare for medical device manufacturers and Notified Bodies alike.
The FDA go-to-market process remains linear, with products moving in one direction from submission to market approval. Only changes requiring a new FDA 510(k) cause a product to slide backward against the flow. MDR involves a pre-application, application and initial certification to get through before ending up in the perpetual motion machine that is the recertification process. This constant loop extends for the entire lifecycle of the product, leaving manufacturers dizzy and Notified Bodies scrambling to find resources to meet the demand.
As of late April 2022, 28 Notified Bodies were designated for MDR. This is a dramatic reduction from the 126 designated under MDD, thanks to a lengthy, complex and expensive MDR certification process.
Many Notified Bodies simply opted not to pursue the designation. The Notified Bodies that received designation had to rapidly ramp up their staffing to comply and meet skyrocketing demand. The Notified Bodies have significantly increased their resources annually, and it’s still not enough.
They’re competing with manufacturers and consulting firms for the limited pool of candidates with the competencies, skillsets and certifications required by MDR. And simply hiring people doesn’t immediately resolve staffing issues, as new reviewers need training before participating in the certification process. Technical reviewers can take up to 18 months to train, while clinical reviewers need 24 months to get up to speed.
To make matters worse, the bulk of the MDD and Active Implantable Medical Devices Directive (AIMDD) certificates for legacy devices expire in May 2024, leaving manufacturers and Notified Bodies scrambling to get MDR certificates issued before the deadline. Notified Bodies have been telling clients to get their application in at least 18 months before the MDD expiration date. Therefore, manufacturers that do not submit their documentation by December 2022 risk having their product removed from the market.
Given the scarcity of Notified Body resources, companies should be in communication with their Notified Body to secure a review spot. Technical documentation must be updated in full at the time the review begins or the company risks losing their place in the queue.
It’s not just the Notified Bodies that are struggling, though. As of December 2020, only 1% of medical device manufacturers have successfully transitioned to MDR. These are primarily larger companies with the technical and financial resources to withstand the rigors of certification. Only 10% of manufacturers are in the process of transitioning to MDR, leaving almost 90% of companies facing an uncertain future in the EU.
All these factors play a role in determining whether the EU market makes sense for your product. More stringent regulation means the European market no longer promises ease of entry and instant revenue. Additionally, the tender-based model puts even more stress on manufacturers trying to meet the deadline and capture their percentage of the available market.
Those devices currently on the market risk becoming commodities, and startups with new and novel concepts are going to think twice about bringing their products to market in Europe. It’s a difficult decision that poses a real threat to healthcare in Europe. The situation could potentially cause patients to suffer the effects of fewer devices and a lack of novel technologies to advance the treatment of rare disease states.
Michelle Lott is the Founder and Principal of leanRAQA. In June she presents at OMTEC® 2022 in Chicago, Illinois, sharing insight on FDA’s thinking about additive, AI and digital health in orthopedics as well as an overview of the regulatory pathways for breakthrough or de novo devices.
