Essential Requirements and Essential Principles for Medical Devices

Medical devices directly affect human life and health, making it critically important to ensure their safety and effectiveness. The foundation for achieving this is the “Essential Requirements” or “Essential Principles” for medical devices.

The Essential Requirements (or Essential Principles) for medical devices are fundamental requirements that all medical devices and in vitro diagnostic medical devices must meet regarding quality, effectiveness, and safety. In 2005, the Global Harmonization Task Force (GHTF) established these as “common requirements necessary for design and manufacture to ensure safety when considering the use of all medical devices” (GHTF/SG1/N41R9:2005). Following this international harmonization, Japan also established its “Essential Requirements Standard” (Ministry of Health, Labour and Welfare Notification No. 122 of 2005) in 2005.

When submitting applications for manufacturing and marketing approval, certification, or notification of medical devices, manufacturers must submit documentation demonstrating conformity with the Essential Requirements Standard. If a device does not meet these standards, the application will either not be accepted, be rejected, or will not receive certification/approval. In other words, conformity with the Essential Requirements is a mandatory prerequisite for bringing medical devices to market.

Structure of the Essential Requirements

The Essential Requirements are broadly composed of the following elements:

1. General Requirements for Design and Manufacture

Medical devices must be designed and manufactured to achieve their intended purpose and intended effects/effectiveness. Requirements are established to minimize risks to patients and users. Specifically, the following are required: ensuring safety, minimizing risks, ensuring long-term safety and reliability, and maintaining quality during transportation and storage.

2. Performance Requirements

Performance requirements are specified to ensure that medical devices fulfill their intended functions. For example, this includes measurement accuracy for measuring instruments and stability of therapeutic effects for treatment devices.

3. Safety Requirements

These are requirements to ensure the safety of patients and users, and include mechanical safety, electrical safety, biological safety, radiation safety, and thermal safety.

4. Requirements for Labeling and Instructions for Use

Requirements are specified for providing information necessary for users to properly use medical devices. This includes device identification information, warnings and precautions, instructions for use, and information on maintenance and inspection.

International Harmonization and Global Expansion of Medical Devices

The primary reason international harmonization is important is that medical devices are used across borders. Japan’s Essential Requirements Standard is essentially a translation of the GHTF’s Essential Requirements (ER), and similar frameworks have been adopted in countries and regions worldwide.

For example, the European Union (EU) has the General Safety and Performance Requirements (GSPR) in Annex I of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). Australia’s Therapeutic Goods Administration (TGA) has Essential Principles, Canada’s Health Canada has safety and effectiveness requirements, and Brazil’s National Health Surveillance Agency (ANVISA) has regulatory requirements—all based on the GHTF’s ER. Currently, the International Medical Device Regulators Forum (IMDRF) has taken over this harmonization effort, publishing updated guidance in 2024 with “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices” (IMDRF/GRRP WG/N47 FINAL:2024 Edition 2).

The following table summarizes the Essential Requirements/Essential Principles implemented in major countries and regions:

Country/Region	Regulation/Standard	Document Name	Basis
Japan	Essential Requirements Standard	Ministry of Health, Labour and Welfare Notification No. 122 of 2005 (revised in 2023, effective April 2024)	Based on GHTF/IMDRF
European Union	MDR/IVDR Annex I	General Safety and Performance Requirements (GSPR)	Based on GHTF/IMDRF
United States	FDA Recognized Consensus Standards	Essential Principles (IMDRF/GRRP WG/N47) – Voluntary guidance	Based on GHTF/IMDRF
Australia	TGA Essential Principles	Essential Principles	Based on GHTF/IMDRF
Canada	Health Canada Requirements	Safety and Effectiveness Requirements	Based on GHTF/IMDRF
Brazil	ANVISA RDC 848/2024	Essential Safety and Performance Requirements	Based on IMDRF/GRRP WG/N47 FINAL:2024
International	IMDRF	Essential Principles of Safety and Performance (IMDRF/GRRP WG/N47 FINAL:2024 Edition 2)	Global harmonization framework

Standards Reference Methods in Each Country

Each country and region has its own characteristics regarding how standards are referenced to meet the Essential Requirements.

Japan: References Japanese Industrial Standards (JIS) that have been domesticated from ISO/IEC international standards, rather than directly referencing the international standards themselves. While the Essential Requirements Standard itself does not directly reference international standards, the Director of the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, issues notifications recommending JIS standards to meet the requirements. Japan revised its Essential Requirements in 2023, which became effective in April 2024.

European Union: Adopts ISO/IEC standards as European Standards (EN) and positions them as harmonized standards. The MDR and IVDR, which became fully applicable in May 2024, include 23 detailed GSPR requirements divided into three chapters: general requirements, requirements regarding design and manufacture, and requirements regarding information supplied with the device.

United States: References standards recognized by the FDA (Recognized Consensus Standards), including ANSI standards, ASTM standards, and specific ISO/IEC standards directly. The FDA’s Recognized Consensus Standards database is regularly updated (most recently List 63 in March 2025) and includes over 1,800 recognized standards. While manufacturers can submit a Declaration of Conformity (DOC) to recognized consensus standards, conformity with standards alone is not necessarily sufficient for approval.

Although the methods of adopting international standards and their designations differ by country, the underlying technical requirements are substantially equivalent, ensuring international harmonization.

Demonstrating Conformity with Essential Requirements

Medical device manufacturers demonstrate that their products conform to the Essential Requirements through the following methods:

1. Conformity with Recognized Standards

By demonstrating conformity with recognized standards such as JIS standards or ISO standards, manufacturers can prove conformity with specific elements of the Essential Requirements.

2. Risk Management

Manufacturers implement risk management based on ISO 14971 and demonstrate that risks are controlled to acceptable levels. This process is conducted continuously throughout the product lifecycle.

3. Clinical Evaluation

As necessary, manufacturers evaluate clinical trials or existing clinical data to prove the effectiveness and safety of medical devices. This is particularly important for medical devices with high novelty or high risk.

4. Creation of Technical Documentation

Manufacturers create technical documentation that includes the above proof materials and submit it for review by regulatory authorities. This documentation includes design specifications, test reports, risk analysis results, and draft instructions for use.

The following table summarizes key documentation requirements:

Documentation Element	Purpose	Key Standards/Guidelines
Risk Management File	Demonstrate acceptable risk control	ISO 14971:2019 (JIS T 14971)
Clinical Evaluation	Demonstrate safety and effectiveness	MDR Annex XIV, FDA guidance
Essential Requirements Checklist	Map conformity to each requirement	GSPR checklist, ER checklist
Standards Conformity	Demonstrate conformity with recognized standards	JIS, EN, FDA Recognized Standards
Design and Development Documentation	Prove design meets specifications	ISO 13485, 21 CFR Part 820
Labeling and Instructions for Use	Ensure proper use information	IMDRF/GRRP WG/N52:2024, ISO 20417

Recent Regulatory Developments

Several important developments have occurred in the international regulatory landscape:

IMDRF Updates (2024): The IMDRF published updated guidance documents in April 2024, including:

• IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2): Essential Principles of Safety and Performance
• IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2): Principles of Labelling for Medical Devices and IVD Medical Devices
• IMDRF/GRRP WG/N71 FINAL:2024 (Edition 2): Regulatory Review Report content guidance

Japan: Revised its Essential Requirements Standard in 2023, with implementation effective from April 1, 2024. Medical devices submitted for approval or certification after this date must demonstrate conformity with the revised Essential Requirements.

European Union: The MDR and IVDR transition periods continue, with all devices placed on the market required to conform to MDR/IVDR as of May 26, 2024. The grace period for MDD-certified devices ended in May 2024, though certain transition timelines allow re-certification up until 2027-2028 for some device classes under specific circumstances.

Brazil: ANVISA published RDC 848/2024 in March 2024, expanding Essential Safety and Performance Requirements to include IVDs and harmonizing with IMDRF guidance IMDRF/GRRP WG/N47 FINAL:2024. This resolution becomes mandatory 180 days after publication.

United States: The FDA continues to update its Recognized Consensus Standards database regularly. List 63, published in March 2025, includes newly recognized standards for sterilization, interoperability, and other areas. Over 1,800 standards are currently recognized, and manufacturers can submit Declarations of Conformity to expedite the review process.

Summary

The Essential Requirements for medical devices are crucial requirements that form the foundation for ensuring the quality, effectiveness, and safety of medical devices. Based on internationally harmonized concepts led by the GHTF and now continued by the IMDRF, these requirements form the core of regulations in countries and regions worldwide.

By conforming to these standards, manufacturers can protect the safety of patients and healthcare professionals and promote the global dissemination of high-quality medical devices. It is essential that all stakeholders involved with medical devices understand the significance of these Essential Requirements and their international harmonization, and respond appropriately. This understanding and proper implementation will lead to safer medical care, continued development of the field, and the worldwide proliferation of innovative medical devices.

Note: This article provides general information about medical device regulations and should not be considered legal or regulatory advice. Manufacturers should consult with regulatory experts and refer to the most current official guidance from relevant regulatory authorities for their specific products and markets.