From QSR to QMSR: What’s Changing and How to Prepare

The FDA is officially replacing its long-standing Quality System Regulation (QSR, 21 CFR Part 820) with the new Quality Management System Regulation (QMSR) — and the clock is ticking.2017/745, MDCG 2019-11, MDCG 2020-16, and MDCG 2021-24:

What’s Changing?:

The QMSR, effective February 2, 2026, brings the U.S. in line with international standards by incorporating ISO 13485:2016 by reference. This means that manufacturers who already comply with ISO 13485 will find many of the requirements familiar — but not identical.

Here’s what you need to know:

Alignment, not duplication – The QMSR aims to eliminate redundant efforts for manufacturers marketing both in the U.S. and internationally.

ISO 13485 becomes the foundation – But the FDA adds clarifications to ensure alignment with the FD&C Act

Some QSR terms (like DMR, DHR, DHF) are no longer used – But their elements still need to be documented under ISO 13485 clauses.

Compliance is still mandatory – Even if you’re ISO 13485 certified, you’ll need to address FDA-specific nuances.

How Can You Prepare?

Start with a gap assessment between your current QMS (QSR or ISO 13485-based) and the QMSR. That’s where our Gap-Assessment Tool comes in.

With just a few clicks, our tool:

• Maps your current QMS against QMSR requirements
• Highlights areas needing updates or clarification
• Provides actionable steps to get you compliant by 2026

Whether you’re QSR-based, ISO 13485 certified, or somewhere in between — our tool simplifies your path to compliance.

Ready to get started? Test Tool here:

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Can medical device software still be classified as Class I software under EU MDR 2017/745?

There is an ongoing discussion about whether medical device software can be classified as Class I under EU MDR 2017/745. Here is my assessment based on EU MDR 2017/745, MDCG 2019-11, MDCG 2020-16, and MDCG 2021-24:

EU MDR Classification Rule 11:

This rule states:

” Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

• death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or
• a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

All other software is classified as class I.”

Class I criteria for Medical Software:

Based on the classification definition according to Rule 11, medical device software can be qualified as a Class I medical device. Here are the criteria that must be met:

• Have a clear medical purpose
• Not be used for a purpose specified in higher risk classes
• Not drive or influence the use of a higher-class medical device
• Perform simple actions beyond storage, archival, communication, support, or basic search functions

Examples:

Here are two examples of software that could potentially be classified as Class I under the EU Medical Device Regulation (MDR):

1.) Simple exercise guidance software: Applications that provide instructions for physical exercises to patients, such as eye exercises or pelvic floor exercises, without monitoring physiological processes or providing diagnostic/therapeutic decisions.

2.) Behavioral change practice software: Applications designed to help patients practice behavioral changes, for example, in managing addictive behaviors, without providing medical diagnoses or treatment decisions.

Conclusion

In conclusion, while it is possible for medical software to be classified as Class I under the EU MDR, the criteria are quite stringent. Many types of medical software will fall into higher risk classes due to their functionality and potential impact on patient health. Manufacturers must carefully assess their software’s intended use and functionality against these classification rules to determine the appropriate class. For such products, I recommend consulting a Notified Body to get more clarity.

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Introduction

This blog explains the concepts of UDI, UDI-DI, and UDI-PI according to the EU Medical Device Regulation (MDR) and EU In-Vitro Diagnostic (IVDR) in more detail to help understand the differences and how to deal with them.

UDI Definitions:

1. UDI (Unique Device Identifier)

The UDI is a series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard like GS1, HIBCC, or ICCBBA. It allows for the unambiguous identification of a specific medical device on the market. The UDI is comprised of two parts: the UDI-DI and the UDI-PI.

2. Basic UDI-DI

The Basic UDI-DI is a new concept introduced by the EU MDR and IVDR. It’s important to understand its role:

1. Purpose: The Basic UDI-DI is the main key to access device-related information in regulatory documentation and EUDAMED. It groups devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.

2. Format: It should be a string of 8 to 25 characters in length, composed exclusively of uppercase letters (A-Z) and numbers (0-9), without any spaces or hyphens.

3. Relationship to UDI-DI: Multiple UDI-DIs can be associated with a single Basic UDI-DI. This allows for the grouping of device variants or models that share fundamental characteristics.

4. Not on packaging: The Basic UDI-DI is not marked on the device or its packaging. It’s used in relevant documentation and databases only.

5. Regulatory use: It’s used in certificates (EU technical documentation assessment, EU type examination, EU product verification), declarations of conformity, and other regulatory documents.

6. Database entry: When submitting device information to EUDAMED, manufacturers must provide both the Basic UDI-DI and the associated UDI-DI(s).

3. UDI-DI (Unique Device Identifier – Device Identifier):

The UDI-DI is specific to a manufacturer and a device. It provides access to the information laid down in Part B of Annex VI of the MDR. Key points about UDI-DI:

– It’s unique to a specific device model.

– It’s the main key for device-related information in the UDI database (part of EUDAMED).

– It remains constant for the same device version/model.

– A new UDI-DI is required when there’s a change that could lead to misidentification of the device or ambiguity in its traceability.

4. UDI-PI (Unique Device Identifier – Production Identifier):

The UDI-PI identifies the unit of device production and, if applicable, the packaged devices. Key points about UDI-PI:

– It may include information such as the lot or serial number, expiration date, manufacturing date, or software version.

– It varies for each production unit, providing traceability for individual devices or batches.

– The type of UDI-PI used (e.g., serial number, lot number, expiry date) needs to be reported to EUDAMED, but the actual UDI-PI values are not stored in the database.

How to deal with UDI as a manufacturer:

1. Assignment: You must assign a UDI to your device and all higher levels of packaging before placing it on the market (except for custom-made and investigational devices).

2. UDI Carrier: Place the UDI carrier (containing both UDI-DI and UDI-PI) on the device label or packaging. For reusable devices, it should also be on the device itself.

3. Basic UDI-DI: Assign a Basic UDI-DI, which is a separate identifier used to group devices with the same intended purpose, risk class, and essential design and manufacturing characteristics. This is used in relevant documentation and as the main access key in EUDAMED.

4. Database submission: Ensure that the device information is correctly submitted to EUDAMED, including the UDI-DI and the types of UDI-PI used.

5. Changes requiring new UDI-DI: Be aware of changes that require a new UDI-DI, such as:

• Name or trade name changes
• Device version or model changes
• Labeling as single-use
• Packaged sterile
• Need for sterilization before use
• Quantity of devices in a package
• Critical warnings or contraindications

6. Maintain records: Keep up-to-date records of all UDIs assigned to your devices.

7. Comply with coding standards: Use only coding standards provided by issuing entities designated by the European Commission.

8. Reusable devices: Ensure the UDI carrier is permanent and readable after each reprocessing cycle for the device’s intended lifetime. A great technology can be laser marking where for example FOBA Laser is one of the leaders in this industry.

Example of a hypothetical UDI number based on GS1:

Basic UDI-DI: 796436712345ABCD9

UDI: (01)07964367123459(11)220315(17)250315(10)A373B2(21)1234

Let’s break this down:

1. Basic UDI-DI (GMN): 796436712345ABCD9

• 7964367 (GS1 Company Prefix)
• 12345ABCD (Model Reference)
• 9 (Check Character)
• This is a separate identifier, not physically marked on the device or its packaging
• It serves as the main key for device-related information in the UDI database (EUDAMED)

2. UDI-DI: (01)07964367123459

• (01) is the Application Identifier (AI) for GTIN
• 07964367123459 is the GTIN, identifying the specific device model

3. UDI-PI:

1. (11)220315 – Production date (March 15, 2022)
2. (17)250315 – Expiration date (March 15, 2025)
3. (10)A373B2 – Batch/lot number
4. (21)1234 – Serial number

It’s important to note that not all UDIs will contain all of these elements. The exact composition depends on the device type, its intended use, and applicable regulations. For instance, some devices might not have an expiration date, while others might not require a serial number.

As a manufacturer, you would need to determine which of these elements are necessary for your specific device based on its characteristics and the regulatory requirements it falls under. The UDI-DI is always required, while the elements of the UDI-PI may vary depending on the device type and applicable regulations.

Conclusion

The UDI system is essential for improving the traceability and safety of medical devices within the EU regulatory framework. It consists of the UDI-DI, which uniquely identifies a specific device model, and the UDI-PI, which tracks individual production units. The Basic UDI-DI serves as a key for accessing device-related information in regulatory documentation and is used to group devices with similar characteristics. Manufacturers are responsible for assigning UDIs, ensuring they are properly marked on devices and packaging, and submitting accurate information to EUDAMED. Compliance with these requirements enhances device identification, facilitates recalls, and ultimately contributes to patient safety.

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Understanding Intended Purpose – A Critical Element for Medical Devices and IVDs in the EU

The intended purpose of a medical device or in vitro diagnostic device (IVD) is a fundamental concept in EU regulations. It plays a crucial role in device classification, conformity assessment, and ensuring safety and performance. This article explores what the intended purpose means, why it’s important, and how manufacturers should define it under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).

What is Intended Purpose?

The MDR and IVDR define intended purpose as “the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation” (MDR Article 2(12), IVDR Article 2(12)).

In simpler terms, it’s a comprehensive description of what the device is designed to do, who should use it, for whom, and under what circumstances.

Main Challenges of creating the right Intended Purpose

1 Striking the right balance of specificity: The intended purpose needs to be specific enough to clearly define the device’s use, but not so narrow that it unduly limits legitimate uses or requires frequent updates.

2. Consistency across documentation: Ensuring the intended purpose is consistently described across all relevant documents (labeling, instructions for use, technical files, clinical evaluation, etc.) can be challenging.

3. Anticipating foreseeable uses: Manufacturers need to consider and address all reasonably foreseeable uses of the device, including potential misuse, which can be difficult to predict.

4.  Avoiding overly broad claims: There’s a temptation to make the intended purpose as broad as possible, but manufacturers must avoid claims that cannot be substantiated by clinical evidence.

5. Addressing multiple components: For complex devices or systems, clearly articulating the intended purpose for each component while maintaining a coherent overall statement can be challenging.

6. Keeping up with technological advancements: As technology evolves, especially in areas like software and AI, defining the intended purpose in a way that remains relevant can be difficult.

7. Aligning with classification rules: The intended purpose directly impacts device classification, so crafting it to accurately reflect the device’s risk class while meeting business objectives can be challenging.

8. Addressing different user groups: Clearly defining the intended users, their required skills, and the target patient population in a comprehensive yet concise manner can be complex.

9. Regulatory variations: While trying to maintain a globally consistent intended purpose, addressing slight variations in regulatory requirements across different markets can be challenging.

10. Regular review and updates: Ensuring the intended purpose remains current and accurate throughout the device lifecycle, and managing any necessary updates, can be an ongoing challenge.

Key Components of Intended Purpose

An intended purpose statement should typically include:

– Medical function (e.g. diagnosis, treatment, monitoring)

– Specific medical condition or disease addressed

– Intended user (e.g. healthcare professional, patient)

– Target patient population

– Use environment (e.g. hospital, home)

– For IVDs: analyte to be detected, specimen types

Importance of Intended Purpose

The intended purpose is critical because it:

– Determines device classification and applicable regulatory requirements

– Guides the clinical evaluation or performance evaluation process

– Informs the risk management process

– Sets the boundaries for device marketing and promotion

– Provides essential information for users in the labeling and instructions for use

Defining Intended Purpose: Key Considerations

When defining the intended purpose, manufacturers should:

– Be specific and clear to avoid ambiguity

– Consider all reasonably foreseeable uses of the device

– Avoid overly broad claims that cannot be substantiated

Checklist of Defining an Intended Purpose:

Regulatory Requirements

The intended purpose must be clearly stated in:

– Device labeling and instructions for use (MDR Annex I Section 23.1, IVDR Annex I Section 20.1)

– Technical documentation (MDR Annex II Section 1.1, IVDR Annex II Section 1.1)

– Clinical evaluation or performance evaluation documentation

– EU declaration of conformity

Conclusion

Defining a clear and comprehensive intended purpose is not just a regulatory requirement—it’s a fundamental step in ensuring the safety and effectiveness of medical devices and IVDs. By carefully considering and articulating the intended purpose, manufacturers can better navigate the regulatory landscape, manage risks, and ultimately provide safer and more effective products for patients and healthcare providers.

For manufacturers, investing time and effort in crafting a precise intended purpose statement is an essential part of bringing a medical device or IVD to market in the EU. It sets the foundation for regulatory compliance and helps ensure that devices are used safely and effectively for their intended purposes.

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“Placing on the market” vs “Making available on the market”

The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) make important distinctions between ‘making available on the market’ and ‘placing on the market’ for medical devices and IVDs. Understanding these concepts is crucial for manufacturers and economic operators to ensure compliance.

Placing on the Market:

MDR Article 2(28) and IVDR Article 2(21) define ‘placing on the market’ as “the first making available of a device, other than an investigational device, on the Union market.” This refers specifically to the initial introduction of an individual device to the EU market.

Making Available on the Market:

According to MDR Article 2(27) and IVDR Article 2(20), ‘making available on the market’ means “any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.” This broad definition covers any supply of a device within the EU market after its initial introduction.

Key Differences:

1. Timing: ‘Placing on the market’ occurs only once – when a device is first made available. ‘Making available’ can occur multiple times throughout a device’s lifecycle.

2. Compliance requirements: Devices must fully comply with MDR/IVDR requirements at the time of ‘placing on the market’. Subsequent ‘making available’ does not require re-assessment of compliance.

3. Responsibility: Manufacturers and importers are primarily responsible for ‘placing on the market’, while distributors are typically involved in subsequent ‘making available’.

4. Scope: ‘Placing on the market’ applies to each individual device, not just device types.

Understanding these distinctions is essential for economic operators to fulfill their obligations under the MDR and IVDR, ensuring the safety and compliance of medical devices in the EU market.

For non-EU-based Manufacturers

The distinction between ‘placing on the market’ and ‘making available on the market’ has important implications for none EU-based medical device companies selling their product in the European market under EU regulations:

Placing on the market:

– This refers to the first time the device is made available on the EU market.

– For a none EU-based company, this typically occurs when they first transfer ownership of the device to an EU-based importer or distributor.

– The device must fully comply with all applicable EU MDR requirements at this point.

– The non-EU manufacturer is responsible for ensuring compliance before placing the device on the market.

Making available on the market:

– This refers to any subsequent distribution or supply of the device within the EU market after it has been placed on the market.

– For the non-EU company, this usually involves their EU-based partners (importers, distributors) supplying the device to end users or other economic operators.

Key implications:

1. Compliance timing: The non-EU company must ensure their device meets all EU MDR/IVDR requirements before it is first placed on the market by their EU importer/distributor.

2. Responsibilities:

   – The non-EU manufacturer is primarily responsible for the initial ‘placing on the market’ and must fulfill all manufacturer obligations under the MDR/IVDR.

   – EU-based importers and distributors are responsible for subsequent ‘making available’ activities and have their own set of obligations under Articles 13 and 14 of the MDR.

3. Authorized Representative: The non-EU company must designate an EU Authorized Representative to fulfill certain regulatory obligations on its behalf within the EU.

4. Documentation: The non-EU company must provide an EU Declaration of Conformity and technical documentation to their EU partners for the initial placing on the market.

5. Post-market surveillance: The non-EU company must have systems in place to monitor the performance of their device once it’s placed on the EU market and made available to end users.

6. Traceability: The non-EU company must implement UDI systems to ensure the traceability of their devices throughout the supply chain in the EU.

Conclusion

Understanding these distinctions is essential for economic operators to fulfill their obligations under the MDR and IVDR, ensuring the safety and compliance of medical devices in the EU market.

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SOP (Standard Operation Process)

In the highly regulated medical device industry, processes and SOP’s (Standard Operating Procedures) are indispensable. They help to increase quality and consistency in the development and production of products like Medical Devices. The main regulations and standards in this area are ISO 13485, QSR 21 CFR 820, and the new QMSR. This article will delve into the importance of processes and SOP’s that are required, providing a list of such important processes and SOP’s, how to craft them and best practices for maintaining them.

What are SOP’s?

SOPs are detailed, written instructions designed to achieve uniformity in the performance of specific functions. In the medical device field, SOPs cover various aspects including design controls, manufacturing processes, risk management, and quality assurance.

Differences Between SOPs and Processes

Understanding the distinction between SOP’s and processes is crucial. Both play integral roles in ensuring consistency, quality, and regulatory compliance, but they serve different purposes and operate at different levels of detail.

Level of Detail

Processes are high-level descriptions that outline the sequence of activities transforming inputs into outputs. They provide a broad overview of what needs to be done and why, often encompassing multiple steps and interactions. For example, a manufacturing process might include steps such as material procurement, assembly, quality control, and packaging.

In contrast, SOPs are detailed, step-by-step instructions for carrying out specific tasks within those broader processes. They are designed to ensure that each task is performed consistently and correctly every time. An SOP for the quality control step in the manufacturing process might detail the exact procedures for inspecting and testing products, including the specific tools and criteria to be used.

Importance of SOP’s in the Medical Device Industry

1. Regulatory Compliance: SOPs help companies comply with regulatory requirements, reducing the risk of non-compliance penalties.
2. Consistency and Quality: They ensure that every task is performed consistently, leading to high-quality products.
3. Training and Onboarding: SOPs serve as training material for new employees, ensuring they understand and follow established procedures.
4. Operational Efficiency: Well-documented SOPs streamline operations, reducing errors and improving productivity.

Relevant Processes and SOP’s according to ISO 13485, QSR and QMSR

Best Practices for Writing SOP’s

1. Plan Thoroughly: Before drafting an SOP, plan its structure and content. Identify the purpose of the SOP, the tasks it will cover, and the intended audience.
2. Engage Stakeholders: Involve employees who will use the SOP in the drafting process. Their input can help make the SOP more practical and user-friendly.
3. Review and Revise: Regularly review and update SOPs to ensure they remain relevant and effective. Incorporate feedback from users and changes in regulations or processes.
4. Train Employees: Conduct training sessions to ensure all employees understand and can follow the SOPs. Use quizzes and practical assessments to verify understanding.
5. Document Control: Implement a document control system to manage SOP versions, revisions, and approvals. This ensures that only the most current SOPs are in use.

Common Pitfalls and How to Avoid Them

1. Overly Complex Language: Use simple, clear language to ensure the SOP is understandable to all employees.
2. Lack of Detail: Provide sufficient detail to avoid ambiguity. Include all necessary steps and precautions.
3. Infrequent Updates: Regularly review and update SOPs to reflect changes in processes, technology, or regulations.
4. Poor Training: Ensure that all employees are adequately trained on new and revised SOPs. Use practical assessments to verify their understanding.

Conclusion

SOP’s are the backbone of quality and compliance in the medical device industry. By using a well-structured SOP’s and following best practices, companies can ensure their SOP’s are effective, user-friendly, and compliant with regulatory standards. Regular updates and thorough training are essential to maintaining the relevance and effectiveness of SOP’s.

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SaMD – Software as a Medical Device

This article provide a-depth overview of Software as a Medical Device (SaMD) and its regulatory landscape, focusing on FDA and EU regulations.

Understanding SaMD

Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. This definition is crucial as it distinguishes SaMD from software integrated into hardware medical devices (Software in a Medical Device or SiMD).

Key characteristics of SaMD include:

1. Independence from hardware medical devices
2. Intended for medical purposes (e.g., diagnosis, treatment, monitoring)
3. Ability to run on general-purpose computing platforms

Regulatory Framework in the US (FDA)

The FDA regulates SaMD as medical devices, classifying them based on their intended use and risk level.

Classification:

• Class I: Low risk, subject to general controls.
• Class II: Moderate risk, requiring general controls and special controls, often cleared through the 510(k) premarket notification process.
• Class III: High risk, subject to general controls, special controls, and premarket approval (PMA), which involves rigorous review of clinical data.

The classification determines the regulatory pathway and requirements for market approval. Most SaMD fall under Class II, requiring a 510(k) premarket notification.

Key FDA Guidance Documents:

1. Policy for Device Software Functions and Mobile Medical Applications: This guidance outlines the FDA’s regulatory oversight of software functions that meet the definition of a medical device and could pose risks to patient safety if malfunctioning.
2. Clinical Decision Support Software: Provides guidelines for software that assists healthcare providers in making clinical decisions.
3. Software as a Medical Device defined by the International Medical Device Regulators Forum (IMDRF)

Artificial Intelligence and Machine Learning:

The FDA is actively working on a regulatory framework for AI/ML-based SaMD. They released the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan“.

Regulatory Framework in the EU

In the EU, SaMD is regulated under the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).

Classification:

The EU uses a risk-based classification system with four classes:

• Class I
• Class IIa
• Class IIb
• Class III

Most SaMD fall under Class IIa or higher, requiring involvement of a Notified Body for conformity assessment.

Key Regulatory Requirements:

1. EU MDR 2017/745 or EU IVDR 2017/746
2. Quality Management System (ISO 13485)

MDCG Guidance:

The Medical Device Coordination Group (MDCG) has issued several guidance documents relevant to SaMD, including:

• MDCG 2019-11 on Qualification and Classification of Software
• MDCG 2019-16 Rev, 1 – Guidance on cybersecurity for medical devices
• MDCG 2020-1 – Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
• MDCG 2023-4 – Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components

SaMD Decision Tree according to EU MDR and EU IVDR

:

Emerging Trends and Challenges

1. AI/ML Integration: As AI and ML become more prevalent in SaMD, regulators are adapting their approaches. Stay informed about evolving guidelines for AI/ML-based SaMD.
2. Real-World Evidence: Both FDA and EU regulators are increasingly accepting real-world evidence for regulatory decisions. Consider how to leverage this in your clinical evaluation strategy.
3. Interoperability: As healthcare systems become more interconnected, ensure your SaMD can safely and effectively integrate with other systems.
4. Rapid Iteration: Balance the need for quick software updates with regulatory requirements for change management and validation.

Conclusion:

In conclusion, navigating the regulatory landscape for SaMD requires a thorough understanding of both software development and medical device regulations. Stay informed about regulatory updates, engage with regulators early in the development process, and maintain a strong focus on patient safety and product quality throughout the SaMD lifecycle.

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Standard Manufacturing in the Medical Device Industry: A Comprehensive Guide

In the highly regulated medical device industry, “standard manufacturing” refers to the consistent and controlled production processes that ensure devices meet stringent quality, safety, and performance standards. This article aims to provide a clear understanding of standard manufacturing practices, their importance, and how they align with regulatory requirements such as ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/746.

What is Standard Manufacturing?

Standard manufacturing in the medical device field involves the implementation of systematic processes and controls to produce medical devices that consistently meet predefined specifications. This includes adherence to regulatory standards, quality management systems, and best practices in production and process control.

Key Components of Standard Manufacturing

1. Quality Management System (QMS)
   • ISO 13485:2016 Compliance: The cornerstone of standard manufacturing is a robust QMS that complies with ISO 13485:2016. This standard specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
2. Design Controls
   • Systematic Approach: Design controls ensure that the design and development processes are well-documented and that the final product meets the intended use and regulatory requirements. This includes design planning, design input, design output, design review, design verification, and design validation.
3. Process Validation
   • Consistency and Reliability: Process validation involves establishing documented evidence that a manufacturing process will consistently produce products meeting their predetermined specifications. This includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
4. Good Manufacturing Practices (GMP)
   • Regulatory Adherence: GMP guidelines ensure that products are consistently produced and controlled according to quality standards. This covers aspects such as personnel training, facility cleanliness, equipment maintenance, and process controls.
5. Risk Management
   • ISO 14971 Compliance: Risk management is integrated throughout the product lifecycle to identify, evaluate, and mitigate risks associated with medical devices. This is essential for ensuring product safety and regulatory compliance.
6. Traceability
   • Document Control: Implementing systems to track components, materials, and finished products throughout the manufacturing process is crucial for effective recalls and post-market surveillance.
7. Documentation and Record-Keeping
   • Regulatory Compliance: Maintaining detailed records of all aspects of the manufacturing process, including batch records, equipment logs, and quality control data, is essential for demonstrating compliance with regulatory requirements.
8. Standard Operating Procedures (SOPs)
   • Consistency and Training: SOPs provide detailed, written instructions for performing routine operations. They ensure consistency in production methods and serve as valuable training resources for employees.
9. Quality Control and Assurance
   • Inspection and Testing: Implementing rigorous quality control checks throughout the manufacturing process ensures that products meet quality standards. Regular quality assurance audits verify compliance with standards and regulations.
10. Supplier Management
    • Quality Assurance: Careful selection and monitoring of suppliers ensure the quality of raw materials and components. Regular supplier audits and performance evaluations are essential.
11. Environmental Controls
    • Controlled Conditions: Maintaining appropriate environmental conditions (e.g., temperature, humidity, cleanliness) in manufacturing areas is particularly critical for sterile medical devices.
12. Continuous Improvement
    • Ongoing Enhancement: Continuous improvement involves ongoing efforts to enhance manufacturing processes and product quality. This is driven by data analysis and feedback loops.
13. Regulatory Compliance
    • Global Standards: Adherence to relevant regulations such as FDA 21 CFR Part 820 (Quality System Regulation) in the US, EU MDR 2017/745, and EU IVDR 2017/746 in Europe is mandatory. Regular inspections and audits by regulatory bodies ensure compliance.
14. Change Control
    • Controlled Changes: Formal processes for managing and documenting changes to manufacturing processes or product designs ensure that changes are evaluated for their impact on product safety and efficacy.
15. Training and Competence
    • Employee Training: Comprehensive training programs for personnel involved in manufacturing are essential. Regular assessment of employee competence and skills ensures adherence to quality standards.

Benefits of Standard Manufacturing

• Quality Assurance: Ensures that medical devices meet the highest quality standards, enhancing patient safety and product efficacy.
• Regulatory Compliance: Facilitates compliance with global regulatory requirements, minimizing the risk of non-compliance and associated penalties.
• Efficiency and Consistency: Streamlines manufacturing processes, reducing variability and improving operational efficiency.
• Market Competitiveness: Enhances the reputation of the manufacturer, leading to increased market trust and competitiveness.

Conclusion

Standard manufacturing in the medical device industry is a complex and highly regulated process that ensures the consistent production of safe and effective medical devices. By implementing a robust QMS, adhering to regulatory standards, and continuously improving processes, manufacturers can maintain compliance, ensure product quality, and achieve operational excellence. Whether you are a medical device manufacturer or a stakeholder in the industry, understanding and implementing standard manufacturing practices is essential for success in this dynamic and highly regulated field.

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Document Control in general

Document control is a critical aspect of quality management systems in the medical device industry, as outlined in ISO 13485:2016 and reinforced by EU MDR 2017/745 and EU IVDR 2017/746. Here’s an overview of document control requirements according to these standards:ISO 13485:2016 Document Control Requirements:

1. Establish and maintain documented procedures for controlling all documents required by the quality management system.
2. Review and approve documents for adequacy prior to issue.
3. Review, update as necessary, and re-approve documents.
4. Ensure that changes and current revision status of documents are identified.
5. Ensure that relevant versions of applicable documents are available at points of use.
6. Ensure that documents remain legible and readily identifiable.
7. Prevent the unintended use of obsolete documents and apply suitable identification if they are retained.

Document control requirements according to EU MDR 2017/745 and EU IVDR 2017/746

While these regulations don’t provide as detailed requirements for document control as ISO 13485, they emphasize the importance of documentation and record-keeping throughout the product lifecycle:

1. Maintain documentation related to the quality management system, including procedures and records.
2. Keep technical documentation up-to-date and readily available for regulatory authorities.
3. Ensure traceability of all versions, updates, and changes to documentation.
4. Maintain records of post-market surveillance activities and any corrective actions taken.
5. Retain documentation for a period of at least 10 years after the last device has been placed on the market (15 years for implantable devices).

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Document control requirements according to ISO 13485

• Establishing, implementing, and maintaining documented procedures to control all documents required by the quality management system.
• Ensuring that documents remain legible, readily identifiable, and retrievable.
• Ensuring that documents are periodically reviewed and updated as necessary.
• Ensuring that changes to documents are reviewed and approved by authorized personnel.
• Ensuring that relevant versions of applicable documents are available at points of use.
• Ensuring that documents are adequately protected against unauthorized access, use, and loss.
• Retaining documented information for a specified period.

These requirements help ensure that the organization’s documented information is managed effectively to support the quality management system.

Document Control – Relevant Chapters according to ISO 13485

These sections outline the requirements for establishing and maintaining a document control system within a medical device quality management system. It includes aspects such as creating, updating, controlling documents, and ensuring proper documentation of processes and activities.

• Section 4.2: Documented Information
• Section 4.2.4: Control of Documents
• Section 4.2.5: Control of Records
• Section 7.5: Documented Information
• Section 7.5.1: General
• Section 7.5.2: Creating and Updating
• Section 7.5.3: Control of Documented Information

Key Aspects of Document Control:

• Version Control: Implement a system to track document versions and revisions.
• Access Control: Ensure that only authorized personnel can modify documents.
• Distribution Control: Manage the distribution of documents to ensure the right people have access to the most current versions.
• Retention: Establish policies for document retention in line with regulatory requirements.
• Electronic Document Management: If using electronic systems, ensure they meet the requirements for data integrity and security.

Document Control Process

A document control process according to ISO 13485:2016 involves systematic and comprehensive management of all documents required by the quality management system (QMS). Below is a detailed outline of what this process should include:

1. Establish Documented Procedures

• Create and maintain documented procedures for controlling all QMS documents. This ensures consistency and compliance with ISO 13485:2016 requirements.

2. Document Review and Approval

• Review and approve documents for adequacy prior to issuance. This step ensures that all documents are accurate, complete, and meet regulatory requirements before they are used.

3. Document Updates and Re-approval

• Review and update documents as necessary, and re-approve them. This involves periodic reviews to ensure documents remain current and reflect any changes in processes, regulations, or standards.

4. Identification of Changes and Revision Status

• Identify changes and the current revision status of documents. Implement a version control system to track document revisions and ensure that users can easily identify the latest version.

5. Availability at Points of Use

• Ensure relevant versions of applicable documents are available at points of use. This means making sure that employees have access to the most current documents needed for their tasks.

6. Document Legibility and Identifiability

• Ensure documents remain legible and readily identifiable. This involves maintaining document quality so that they are easily readable and recognizable.

7. Control of Obsolete Documents

• Prevent the unintended use of obsolete documents. Implement procedures to remove outdated documents from points of use and mark them clearly if they need to be retained for any reason.

8. Version Control

• Implement a version control system to track document versions and revisions. This helps in maintaining a clear history of changes and ensures that only the most current documents are in use.

9. Access Control

• Ensure that only authorized personnel can modify documents. Implement access controls to restrict document editing to qualified individuals, thereby maintaining document integrity.

10. Distribution Control

• Manage the distribution of documents to ensure the right people have access to the most current versions. This involves controlled dissemination of documents to relevant stakeholders.

11. Document Retention

• Establish policies for document retention in line with regulatory requirements. For example, retain documentation for at least 10 years after the last device has been placed on the market, or 15 years for implantable devices.

12. Electronic Document Management (eDMS)

• If using electronic systems, ensure they meet requirements for data integrity and security. An eDMS can enhance efficiency by automating workflows for review, approval, and distribution while ensuring compliance with regulatory standards like 21 CFR Part 11.

13. Integration with Other QMS Processes

• Integrate document control with other QMS processes such as design controls, risk management, supplier management, production controls, and CAPA. This ensures that document control supports the overall effectiveness of the QMS.

14. Training and Competence

• Provide training on document control procedures. Ensure that all personnel are competent in handling documents according to established procedures, which is crucial for maintaining compliance and quality.

15. Audit Trail and Traceability

• Maintain a clear audit trail for documents. Keep records of document changes, approvals, and distribution to support traceability and facilitate audits.

16. Performance Metrics and Continuous Improvement

• Monitor performance metrics for document control. Use key performance indicators (KPIs) to assess the efficiency and effectiveness of the document control process and drive continuous improvement.

17. Regulatory Inspections and Audits

• Prepare for regulatory inspections and audits. Organize documentation for easy retrieval and demonstrate compliance with ISO 13485:2016 requirements during audits.

Implementing these practices ensures that the document control process is robust, compliant with ISO 13485:2016, and supports the overall quality and safety of medical devices.

Other relevant Processes and SOP’s related to ISO 13485, EU MDR and EU IVDR

The document control process is just one of many important processes. In the following article you will find more detailed information.

Conclusion

Implementing robust document control helps medical device manufacturers maintain compliance with regulatory requirements, ensure product quality and safety, and facilitate efficient operations. It’s crucial to establish a systematic approach to document management that aligns with the specific requirements of ISO 13485, EU MDR, and EU IVDR while also meeting the unique needs of the organization.

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Quality Assurance vs Quality Control

In the medical device industry, ensuring the safety and effectiveness of products is paramount. This is achieved through two critical functions: Quality Assurance (QA) and Quality Control (QC). Although these terms are often used interchangeably, they refer to distinct processes that play unique roles in the overall quality management system (QMS). Understanding the differences between QA and QC is essential for maintaining high standards such as ISO 13485 and regulatory compliance.

Quality Assurance (QA)

Quality Assurance is a proactive, process-oriented approach aimed at preventing defects in the manufacturing process. It involves continuous monitoring and improvement of processes to ensure that they meet predefined standards and regulatory requirements.

Key Aspects of Quality Assurance:

1. Process Focus: QA emphasizes the manufacturing process, ensuring that every step is performed correctly to prevent defects.
2. Proactive Measures: QA involves planning and implementing processes to avoid issues before they occur.
3. Continuous Improvement: The PDCA (Plan-Do-Check-Act) cycle is commonly used in QA to continuously improve processes.
4. Regulatory Compliance: QA ensures that all processes comply with regulatory standards such as those set by the FDA, ISO, and others.

Common QA Activities:

• Audits: Regular inspections to ensure compliance with internal and external standards.
• Process Definitions: Detailed documentation of each process to ensure consistency and clarity.
• Tool Evaluation: Regular assessment and calibration of tools and equipment used in manufacturing.
• Training: Ongoing training for staff to ensure they are knowledgeable about QA processes and standards.

Processes and SOP’s for QA’s in the Medical Device Industry

We provide a bunch of helpful documents and articles related to processes and SOP’s in the medical device industry. In the following article you will find detailed information about required processes related to ISO 13485, EU MDR 2017/745 and EU IVDR 2017/746. CLICK HERE

Quality Control (QC)

Quality Control is a reactive, product-oriented approach that focuses on identifying defects in the final product. It involves testing and inspection of products to ensure they meet the required specifications before they are released to the market.

Key Aspects of Quality Control:

1. Product Focus: QC emphasizes the final product, ensuring it meets all specifications and standards.
2. Reactive Measures: QC identifies and addresses defects after the product has been manufactured.
3. Testing and Inspection: QC involves rigorous testing and inspection to catch any defects before products reach the end-user.
4. Corrective Actions: When defects are found, QC teams initiate corrective and preventive actions (CAPA) to address the root cause and prevent recurrence.

Common QC Activities:

• Acceptance Criteria: Establishing and documenting criteria for product acceptance.
• Product Testing: Conducting tests to verify that products meet the required specifications.
• CAPA Management: Investigating nonconforming products and implementing corrective actions.

10 Key differences between Quality Assurance vs Quality Control

This table shows the main essential differences between QA and QC:

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These differences highlight the distinct roles that QA and QC play in ensuring the overall quality of products and services.

Integration of QA and QC with Elly

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Conclusion

Understanding the distinction between Quality Assurance and Quality Control is crucial for maintaining high standards in the medical device industry. While Quality Assurance focuses on preventing defects through process optimization, Quality Control ensures that the final product is free from defects. By integrating advanced tools like Elly, companies can enhance their QA and QC efforts, ensuring the delivery of safe and effective medical devices.

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