The European Union (EU) is the largest market for U.S. medical technology (MedTech) exports, accounting for nearly 40% of the $21.6 billion in exports in 2018 alone. However, recent changes to the EU Medical Device Regulation (MDR), effective since May 26, 2021, have created significant hurdles for U.S. exporters, detailed in a whitepaper from the Minnesota District Export Council (DEC).
Key Challenges
The whitepaper explains these key challenges:
1. Lack of Notified Bodies (NBs)
Only 20% of medical devices have been certified under the new MDR, with deadlines looming. An NB is an organization designated by an EU Member State to assess the conformity of certain products before being placed on the market. The shortage of NBs is causing delays in market access for U.S. exporters.
2. Increased Regulatory Complexity
The new MDR is highly complex, leading to continuous extensions of implementation deadlines. This ever-increasing complexity makes compliance challenging and unpredictable for MedTech exporters.
3. Withdrawal of Manufacturers
Due to these stringent regulations, approximately 15,000 medical devices have been withdrawn from the EU market. This withdrawal limits patient access to critical medical devices.
4. Exorbitant Fees
Certification fees by EU NBs can average $100,000, but reach much higher, compared to the U.S. FDA’s annual registration fee of $6,493. These high costs are driving small and medium-sized U.S. companies out of the EU market. NBs are for-profit agencies and lack the capacity to cover their existing client base, driving costs up.
5. Reregistration Requirements
The MDR mandates recertification every three to five years, even if the device has not changed, further adding to the financial and administrative burden on manufacturers.
Recommendations
The DEC whitepaper explains these challenges in more detail and offers several recommendations to address what is increasingly being viewed as a non-tariff trade barrier. You can read the full whitepaper here: EU Medical Device Regulations: Lack of Certification Resources, Exorbitant Fees, and Slow Standards-Harmonization Impede U.S.-EU Trade.
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