List of Applicable standard (LOAS)/ ISO Medical Device Standards
LOAS (Letter of Agreement or Specification) is a crucial document that outlines the requirements, specifications, guidelines, or characteristics essential for ensuring that materials, products, processes, and services meet the necessary standards for their intended purpose or use. It serves as a key reference point to guarantee that all elements of the product development process are aligned with regulatory and industry expectations.
Before launching a medical device in the EU, manufacturers must confirm that their device complies with EU regulations and medical device standards, ensuring it meets safety and performance requirements. It is vital for manufacturers to address several key aspects early in the development process to determine the relevant ISO medical device standards and ensure compliance with all necessary guidelines.
Key considerations include:
- The intended use or purpose of the device
- The specific user population the device is designed for
- The target countries for marketing and selling the device
- The environment in which the device will be utilized
By carefully reviewing these factors, manufacturers can generate a comprehensive list of applicable standards for medical devices, ensuring full compliance with ISO standards for medical devices and other relevant regulations.
How to identify which standards are applicable to your device?
Determining the applicable standards for your medical device is a crucial step in ensuring compliance with regulatory requirements. This process can be complex due to the absence of a centralized resource for all standards.
1. Start with Harmonized Standards:
Harmonized standards are recognized across multiple jurisdictions and serve as a reliable starting point. In the European Union, for instance, devices conforming to relevant harmonized standards are presumed to meet the requirements of the Medical Device Regulation (EU) 2017/745 (EU MDR). Examples include:
- EN 1041:2008: Information supplied by the manufacturer of medical devices.
- EN 556-1:2001: Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices.
2. Consider Semi-Harmonized Standards:
Next, explore semi-harmonized standards that may apply to specific aspects of your device. For example, ISO 10993 provides guidelines for the biological evaluation of medical devices, assessing the biocompatibility of materials in contact with the human body. These are part of the broader ISO medical device standards.
3. Identify Product-Specific Standards:
Search for standards specific to your device type through databases such as the Official Journal of the European Union, the International Organization for Standardization (ISO), ASTM International, or other relevant organizations. For instance, ISO standards for medical devices provide detailed frameworks for various types of devices.
4. Review Applicable Guidelines:
Depending on your device, additional guidelines may be relevant. For instance, devices listed in Annex XVI of the EU MDR, those lacking product-specific standards, or those classified as high-risk may require adherence to common specifications.
5. Address Novel Technologies:
If your device incorporates new technologies or features, existing standards may not yet be available or may be in draft form. In such cases, consult with the relevant regulatory authority to determine the appropriate approach for demonstrating conformity to medical device standards.
6. Verify Standard Versions and Recognition:
Ensure that the versions of the standards you intend to apply are recognized by the target countries. Some countries may have their own national versions or may consider certain standards as voluntary rather than mandatory.
By systematically following these steps, you can identify the applicable iso standards for medical devices, facilitating compliance with regulations such as ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/746.
List of ISO Standards for Medical Devices
ISO standards play a critical role in ensuring the safety, effectiveness, and quality of medical devices worldwide. Some of the key ISO standards for medical devices include:
- ISO 13485:2016: Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services consistently meeting customer and regulatory requirements.
- ISO 14971:2019: Provides a framework for risk management in the design and manufacturing of medical devices.
- ISO 10993: Focuses on the biological evaluation of medical devices, ensuring materials are biocompatible.
- ISO 6009: Addresses the packaging of medical devices to ensure protection during transportation and storage.
These standards, along with others, form the backbone of device safety and regulatory compliance, ensuring products meet the necessary requirements for market access.
FAQ:
Medical device standards are formal documents that outline specifications, guidelines, and requirements to ensure the safety, performance, and quality of medical devices throughout their lifecycle. These standards help manufacturers demonstrate compliance with regulatory frameworks.
Commonly Applied Standards for Medical Devices:
1. ISO 13485:2016 – Quality management system
2. ISO 14971:2019 – Risk management
3. ISO 10993 series – Biocompatibility
4. EN 1041:2008 – labelling and instructions for use.
5. EN ISO 15223-1 – Symbols for labelling
6. EN ISO 11135 / 11137 / 17665 – Sterilisation methods
7. EN 60601 series – Electrical safety and performance
Standards can be harmonised, Semi-harmonised or consensus and Product-specific.
Identifying applicable standards depends on the device’s intended use, target markets, risk classification, and technology used. Manufacturers should systematically assess these elements to compile a List of Applicable Standards (LOAS).
THE EU MDR and FDA both use international standards like ISO 14971, ISO 10993, and IEC 60601 to assess medical device safety and performance. In the EU, using harmonised standards provides a presumption of conformity with MDR’s General Safety and Performance Requirements, and a DOC is mandatory. In the U.S, FDA accepts recognised consensus standards to support 510(k) clearance, where the DoC is optional but beneficial. While many standards overlap, differences exist in regulatory approach, language, and documentation. The EU is more prescriptive, whereas the FDA offers flexibility but may require more justification if standards aren’t used.
To identify applicable standards for your medical device, start by defining its intended use, users, markets, and environment.
Refer to the EU’s harmonised standards under MDR 2017/745 and key ISO standards like ISO 13485, ISO 14971, and ISO 10993.
Search ISO, ASTM, and similar databases for device-specific standards.
For high-risk or Annex XVI devices, consult the EU common specifications if standards are lacking.
If using new technology, seek advice from a Notified Body or authority. Always use the latest standard versions accepted in your target market.
This process helps create a List of Applicable Standards (LOAS) for compliance.
A medical device LOAS typically includes standards for:
1. Quality Management (e.g., ISO 13485)
2. Risk Management (e.g., ISO 14971)
3. Biocompatibility (e.g., ISO 10993 series)
4. Sterilization (e.g., ISO 11135, EN 556-1)
5. Labeling & Information (e.g., EN ISO 15223-1, EN 1041)
6. Electrical Safety & EMC (e.g., IEC 60601 series)
7. Packaging & Transport (e.g., ISO 11607, ISO 6009)
8. Software & Cybersecurity (e.g., IEC 62304)
9. Clinical Evaluation (e.g., ISO 14155)
10. Product-Specific Standards (based on device type)
These standards ensure safety, performance, and regulatory compliance.
Maven offers expert support in preparing the List of Applicable Standards (LOAS) by evaluating your medical device’s intended use, target markets, user groups, and technical characteristics. Our team identifies relevant ISO and harmonized standards (including EU MDR 2017/745 and ISO 13485:2016) to ensure your device meets all regulatory and safety requirements. We guide you in selecting product-specific, semi-harmonized, and risk-related standards, and assist with documentation aligned with current EU and international guidelines. With our regulatory expertise, you can confidently streamline your device’s path to market approval.
