February 26, 2026

In the global medical device regulatory landscape, the terms regulations and standards are often used together but they are fundamentally different in authority, purpose, and application.

Understanding how they work together is essential for EU MDR compliance, FDA submissions, ISO certification, and global market access.

What Are Medical Device Regulations?

Medical device regulations are legally binding requirements issued by government authorities. They define the mandatory obligations manufacturers must meet to place devices on the market.

Key Characteristics of Regulations

AspectDescription
Legal StatusMandatory by law
Issued ByRegulatory authorities (EU, FDA, CDSCO, etc.)
PurposeDefine what must be achieved
ConsequenceNon-compliance leads to legal action, recalls, or market denial

Examples of Global Medical Device Regulations

  • EU MDR 2017/745 – European medical device regulation
  • US FDA 21 CFR 820 / QMSR – Quality System Regulation
  • India Medical Device Rules (MDR) 2017
  • Health Canada Medical Device Regulations

These regulations cover clinical evaluation, risk management, post-market surveillance, labeling, vigilance, and quality systems.

What Are Medical Device Standards?

Medical device standards are technical frameworks developed by recognized standards organizations such as ISO, IEC, IEEE, BIS.

They provide structured methodologies that help manufacturers demonstrate conformity with regulatory requirements.

Key Characteristics of Standards

AspectDescription
Legal StatusUsually voluntary, but highly recognized
Issued ByISO, IEC, BIS, ANSI, etc.
PurposeDefine how to meet regulatory expectations
Regulatory RoleUsed to demonstrate state-of-the-art compliance

Examples of Critical Medical Device Standards

  • ISO 13485 – Quality Management Systems
  • ISO 14971 – Risk Management for Medical Devices
  • IEC 60601 – Electrical Safety
  • IEC 62304 – Medical Device Software Lifecycle
  • IEC 81001-5-1 – Cybersecurity for medical software

How Regulations and Standards Work Together

Requirement TypeRegulation SaysStandard Explains
Risk Management“You must manage risks.”ISO 14971 provides the risk process
Quality System“You must operate a QMS.”ISO 13485 defines QMS structure
Software Safety“Software must be safe.”IEC 62304 provides lifecycle controls
Electrical Safety“Device must be electrically safe.”IEC 60601 testing requirements

 Regulations set the obligation. Standards provide a technical pathway.

Why This Distinction Matters in 2026

Regulatory authorities increasingly expect manufacturers to apply harmonized and state-of-the-art standards to prove compliance.

Failure to align standards with regulatory requirements leads to:

  • Notified Body audit findings
  • FDA inspection observations
  • Delays in CE marking
  • Increased technical documentation deficiencies

Regulatory Strategy: Integration, Not Separation

Successful manufacturers do not treat regulations and standards as separate checklists. Instead, they build:

  • ISO 13485 QMS aligned to MDR and FDA expectations
  • ISO 14971 risk files integrated into technical documentation
  • Software and cybersecurity standards embedded in design controls

This approach reduces rework and strengthens regulatory defensibility.

How Maven Regulatory Solutions Supports Compliance

Maven helps medical device manufacturers bridge regulations and standards through:

  • QMS alignment with EU MDR and FDA QMSR
  • Risk management file development (ISO 14971)
  • Technical documentation preparation
  • Software and cybersecurity compliance strategies
  • Gap assessments and audit readiness

We ensure that standards are applied strategically, not just referenced.

FAQ

Are standards mandatory?
Usually not by law, but regulators expect them as proof of compliance.

Can you comply with regulations without standards?
Possible, but difficult and rarely accepted by regulators.

Do standards replace regulations?
No. Standards support regulations but do not replace legal requirements.