Synchronizing Regulatory Clearance & Reimbursement Strategy

Securing FDA clearance, FDA approval, or EU CE marking is a crucial milestone, but regulatory authorization alone does not guarantee commercial success. To avoid the 'Valley of Death', where a cleared medical device sits without market traction, your regulatory roadmap must be directly aligned with health economics, coding, coverage, and reimbursement requirements from day one. Designing clinical trials and technical dossiers with both regulators and payers in mind ensures seamless transition from market access to revenue generation.

Want to learn how to align your regulatory pathways with payer requirements early in development?

Read our full guide on synchronizing regulatory and reimbursement activities for medical devices.

Regulatory Services

  • Regulatory Strategy

    • Preliminary opinion letter, or

      Comprehensive regulatory strategy.

  • Early Interaction

    • With FDA Clearance/Approval: Pre-submissions and Requests for Information (513(g)).

      With European Notified Bodies: Preliminary communication with a potential Notified Body and evaluating approach towards product classification and subsequent requirements.

  • Submissions

    • To FDA: IDE, 510(k), De-Novo, PMA.

      To European Notified Bodies: Technical File, Design Dossier.

QMS and Risk Management

  • QMS Part 1

    • Implementation of relevant parts of your product's Quality Management System (QMS) (e.g., Design Controls and other aspects essential for US and EU pre-study compliance) is a legal requirement in both the US and Europe for devices in medium and higher risk classes prior to starting clinical studies.

      Even for Class I devices, many manufacturers voluntarily implement a QMS at the design stage to reduce the potential for complaints and recalls once the product is launched.

  • QMS Part 2

    • For all but the lowest risk devices, the manufacturer will need to implement a QMS. In the US, compliance with the Quality Management System Regulation (QMSR) detailed in 21 CFR 820 is required for the majority of devices - even some Class I devices. In Europe, compliance with the applicable QMS requirements under the EU Medical Device Regulation (EU MDR 2017/745) is required except for most Class I devices.

      While the clinical study is underway it is the ideal time to turn your management's attention to completing implementation of the selected QMS, expanding it beyond design controls to include such areas as manufacturing, service, CAPA, etc. By the time the investigation is complete, you should have the necessary QMS and regulatory requirements in place to allow the device launch and subsequent marketing.

Clinical Data

  • Clinical Study Protocol

    • The protocol for a medical device clinical study must meet the legal requirements in the countries where the investigation will take place. For the US, protocol approval must be obtained from FDA for a 'significant risk' study, via the Investigational Device Exemption (IDE) process. In Europe, the requirements of standard EN ISO 14155 should be met in order to gain a 'presumption of conformity' with the General Safety and Performance Requirements (GSPRs) related to safety and clinical performance.

  • Clinical Study

    • Prior to commencing any clinical study, Ethics Committee (EC) (or Institutional Review Board in the US) approval must be obtained. Each EC has its own procedures that must be followed in terms of the documentation required, and these must be met at the first opportunity to avoid delays that could compromise milestone achievements and investment.

      After the clinical investigation and publication of the final study report, in Europe a Clinical Evaluation Report (CER) is required throughout the lifecycle of the device and should be developed and maintained as clinical evidence becomes available. This may be based solely on the results of the study, or on a combination of study results and data from the scientific literature. From whatever source the clinical data is derived, the evaluation must follow a "defined and methodologically sound procedure". Even for the US, a well-researched and presented CER can be useful for FDA device clearance or approval.

Frequently Asked Questions

  • What do medical device regulatory consultants do?

    • Medical device regulatory consultants assist medical technology companies in navigating global compliance frameworks, including FDA clearance/approval in the US and CE marking under EU MDR. They define regulatory pathways, prepare technical documentation, and align compliance milestones with commercial reimbursement strategies.

Ready to start synchronizing your reimbursement and regulatory strategies?