Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

Everyone Is Only Reading The MDR Half Of Europe's Reform

The European Commission's simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry the same legal force, and the window to shape them closes this fall.

Chile's Easy Market Ends In 2028

For years, Chile has been a comparatively easy to enter market for the medtech industry. That era now has an expiration date. High-risk, technically complex products will be the most affected by a new decree.

Spanish Is Not One Regulatory Language

Medical device manufacturers with regulatory plans in Latin America often treat translation as a procurement task. But is the translated document usable by the regulator and other key entities in the country in question?

Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.

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WHITE PAPERS & CASE STUDIES

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    The PMCF Decision Guide

    Proposed EU reforms may remove standalone PMCF reporting, yet the duty to proactively collect clinical data remains. Method selection, notified body defense, and data-capture cost determine what comes next.

A Risk Management Approach For The Pharmaceutical Industry

Replacing fluorinated chemistries across pharma isn’t simple. Growing pressures make it critical to prioritize risks and take a sequenced, evidence-based approach to mitigation.

Your Quality Team Is Already Using AI To Draft Compliance Documents

Quality teams already use general-purpose AI for deviations and submission drafts without validation. Regulators expect governance, and the gap is an undocumented process step, not unreliable output.

Why Passing Audits No Longer Predicts Scale

Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations multiply, readiness depends on whether evidence stays connected.

Why Audit Success No Longer Predicts Clinical-Stage Performance

Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between audit readiness and operational readiness opens quietly.

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ABOUT MEDICAL DEVICE REGULATIONS & COMPLIANCE

Medical devices, from ideation to post-launch assessment, are regulated in the United States by the U.S. Food and Drug Administration (FDA) under the Medical Device Regulation Act of 1976 and subsequent amendments to the Federal Food, Drug and Cosmetics Act of 1938.

The FDA’s medical device regulatory pathways — for premarket review, clearance, and approval — are based on three classifications, indicating the degree of regulatory control necessary to ensure a device’s safety and effectiveness. Class I devices are considered low-risk, and many are exempt from the regulatory process. Class II devices require special controls for “labeling, guidance, tracking, design, performance standards, and postmarket monitoring,” and most require premarket notification 510(k) to demonstrate substantial equivalence (having the same intended use and technological characteristics) to a legally marketed device. Class III devices usually sustain or support life, are implanted, or present a significant risk of illness or injury. Most class III devices require premarket approval (PMA), which examines a variety of factors in weighing the probable health benefits from intended use of a device versus the probable risks.

Medical device makers must adhere to Current Good Manufacturing Practice (CGMP) regulations, which FDA inspectors use to determine if a manufacturer has the facilities, skills, and equipment to produce and pack its product. In addition, the FDA requires all medical devices to carry a unique device identifier (UDI), readable by both machines and humans, to “improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.”

Medical device makers competing in international markets must monitor and adhere to the policies of foreign regulatory bodies, which can vary greatly, depending on the nation. Further, many global regulators require manufacturers to be certified by the International Organization for Standardization (ISO). ISO 13485 compliance, confirmed through third-party (Notified Body) audits, demonstrates a medical device manufacturer’s procedures and products meet or exceed international quality standards.

Efforts are also underway to standardize international regulations to ensure the safety, effectiveness, and quality of medical devices. The International Medical Device Regulators Forum (IMDRF) — composed of regulatory agencies from Australia, Brazil, Canada, China, Europe, Japan, Russia, and the United States — is building upon previous work by the Global Harmonization Task Force on Medical Devices (GHTF) to speed this harmonization and convergence.

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