US FAVORED OVER EU FOR MEDICAL DEVICE MARKET ENTRY

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The US market has emerged as the chosen geography for market entry for new medical technology. Historically, medical device companies preferred to launch in Europe as the product registrations were perceived as more straightforward. In a survey from December 2020, the most challenging geography was identified as China and the least challenging was Europe and America.This differs greatly from a more recent survey conducted in March 2022, where over half of the survey respondents state that they consider the EU much more challenging than the US for market entry of Medtech devices.23% of the same survey respondents with successful CE mark products state they are pursuing Japanese and Chinese registration prior to EU clearance. The new MDR rules are perceived as complex and unpredictable, making it less appealing to develop and launch novel products in Europe. The most notable regulatory changes that have occurred between the implementation of the two industry surveys are the adoption of EU MDR and Brexit.

According to Emergo Industry Outlook one of the top challenges that Medtech companies consistently face is the changing regulatory environments.3 The major change in the EU market is the implementation of the EU MDR, replacing the previous Medical Device Directive (MDD). The EU MDR introduces new requirements for medical device manufacturers, such as unique device identification (UDI), general safety and performance requirements (GSPR), improved labeling, more stringent clinical evaluation, and post-market surveillance (PMS), and product tests and design verification. At the clinical trial stage, the MDR sets standards for conducting risk management and clinical evaluations, and the MDR establishes a higher bar for clinical justifications for device equivalence.4 These requirements entail significant investments and resources from industry.  A December 2022 report from Reuters suggests that the costs associated with implementing and complying with EU MDR are prompting Medtech companies to withdraw from the EU market. 5

The regulatory environment in England has changed because of Brexit. The UK introduced a new product marking for medical devices, called the UKCA (UK Conformity Assessed) mark, which indicates that a device conforms to the UK legislation and standards and is required for all medical devices placed on the Great Britain market from 1 July 2023.Additionally, the UK designated new UK Approved Bodies to assess and certify medical devices for the UKCA mark. These bodies are separate from the EU notified bodies and have different requirements and procedures.7 The UK has also introduced a requirement for medical device manufacturers based outside the UK to appoint a single UK Responsible Person for all their devices placed on the Great Britain market. This person acts on behalf of the manufacturer to conduct specified tasks, such as registration, conformity assessment, post-market surveillance, etc.The UK has established a new registration system for all medical devices placed on the Great Britain market. Finally, the UK has introduced new labelling requirements for medical devices placed on the Great Britain market. These include additional information such as UDI (unique device identification), new symbols, CMR/ED substances, etc. 6 The additional approvals and marketing processes for new medical devices are more costly and time-consuming as manufacturers need to follow both EU and UK regulators. 8

Europe is experiencing regulatory change which results in the Medtech industry facing a complex regulatory landscape with different rules and requirements for placing devices on the UK and EU markets. They are coping with the uncertainty and unpredictability of the future trade negotiations between the UK and the EU, affecting the market access and supply chain of medical devices. They also need to ensure that their devices meet the high quality and safety standards expected by the regulators and customers in different markets. The industry needs  to manage different notified bodies and approval authorities , which often have different capacities and competencies.9 Overall, the industry is adjusting to multiple conformity assessments, product markings, registrations, and labelling changes, which entail significant costs and resources.

While EU MDR is perceived to slow the pace of innovation, the US FDA has responded more favorably to innovation. The March 2022 study, listed above, states that 79% of survey respondents agree that the FDA is responding well to advances in medical technology, with industry looking to the FDA’s Digital Health Center of Excellence as a positive development that offers greater clarity and guidance on evolving regulatory pathways.2  Many smaller early-staged companies are making advances in medical and digital technology and are searching for predictable approval pathways to get their device to market in the most cost effective and timely manner. FDA has processes such as Q-Submission, Breakthrough Device Designation and De Novo Classification allowing smaller companies to progress to market clearance while providing assurance of safety and effectiveness for the device’s intended use.

The US FDA is as good an example of how government regulators can adapt to change in the Medtech industry. However, many smaller companies are frustrated on the current state of regulatory efficiency of product requirements.2 The frustration stems from Medtech startups having only months of available cash on hand while trying to balance operational costs with regulatory costs. Smaller companies still face tremendous challenges when dealing with regulators whose time to market schedules often do not sync with their own. Smaller companies are disproportionately responsible for digital innovation, global regulatory agencies must determine how to accommodate time-sensitive requests that could make the difference between a novel device reaching the market or being shelved due to regulatory waiting time.

Reach out to AlvaMed at [email protected] if you need assistance with your product approvals. We specialize in providing support for various regulatory markets.

References:

  1. Kamrow, M. (2020) Organizational communication of regulatory intelligence: a survey of the medical device industry, University of Southern California.
  2. Johnson, C. (March 2022) Interstates and Autobahns Global Medtech Innovation and Regulation in the Digital Age, available at https://www.bcg.com/publications/2022/us-ahead-in-medtech-regulation.
  3. Eisenhart, S. (2021) Global medical device industry outlook for 2021, March 2021. Available at: https://www.emergogroup.com.
  4. Daigle, D. (2018) The EU Medical Device Regulation and the U.S. Medical Device Industry available at https://www.usitc.gov/publications/332/executive_briefings/eu-mdr_ebot_final.pdf.
  5. Fick, M. (2022) Medical device makers drop products as EU law sows chaos, December 19, 2022, available at https://www.reuters.com/business/healthcare-pharmaceuticals/medical-device-makers-drop-products-eu-law-sows-chaos-2022-12-19/.
  6. Dhilawala, A. (2021) How FDA and EU MDR Regulations Differ for Medical Device Companies, available at https://galendata.com/how-fda-and-eu-mdr-regulations-differ-for-medical-device-companies/.
  7. Medicines and Healthcare products Regulatory Agency (2020) Regulating medical devices in the UK, available at https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk.
  8. GlobalData Healthcare (2022) New regulations due to Brexit may limit medical devices from entering the UK available at https://www.medicaldevice-network.com/comment/new-regulations-brexit-medical-devices/.
  9. Criado, B. (2021) The UK regulatory landscape post Brexit, available at https://www.raps.org/news-and-articles/news-articles/2021/5/the-uk-regulatory-landscape-post-brexit.

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