Quality management for Class I medical devices

At medXteam, the focus is on clinical data. In this context, as CRO we not only carry out clinical trials with medical devices in accordance with MDR and ISO 14155, but also offer all other options and forms of data collection. This time it is not about the topic of clinical data, but rather about a basis for medical device manufacturers in general and in particular the manufacturers of Class I products. The MDR requires a quality management system (QMS) for all manufacturers of medical devices. Class I manufacturers must now also have one.

What are the special features? Are there any differences to the manufacturers of products with a higher classification? We will now devote ourselves to this topic in this blog post.

Abbreviations

MDR Medical Device Regulation; EU Regulation 2017/745

QMS quality management system

Underlying regulations

EU Regulation 2017/745 (MDR)
Medical Devices Implementation Act (MPDG)

1 Introduction

The development and manufacture of medical devices are subject to strict regulations to ensure safety and effectiveness. The Medical Device Regulation (MDR) sets clear requirements, particularly for manufacturers of Class I medical devices, which are often classified as low-risk. Article 10 (9) of the MDR requires a quality management system (QMS) for all medical devices - regardless of their risk class.

2. Requirements for a quality management system (QMS)

In the following sections we will now take a closer look at how an effective and compliant QMS for Class I products is set up and operated in order to meet the requirements of the MDR. From the basic principles to practical implementation, you will gain a comprehensive insight into the special features and challenges of quality management for this product class.

2. Requirements for a quality management system (QMS)

2.1 Requirements of Article 10 (9) MDR

Article 10 (9) of the MDR describes the comprehensive requirements for a quality management system (QMS) that manufacturers of medical devices, including Class I devices, must implement and maintain. The aim of the QMS is to ensure that the requirements of the regulation are continuously met, even in series production.

An essential part of this approach is the ability to take changes in product design, properties or relevant normative requirements into account in a timely and appropriate manner. This also includes the continuous improvement of the QMS, which is based on the risk classes and specific features of the products.

Comprehensive QMS requirements

The quality management system must cover all organizational areas of a manufacturer that influence the quality of processes, procedures and products. This applies, among other things:

Structure and responsibilities: Clear definition of tasks and responsibilities within the company.
Processes and procedures: Development and application of effective processes for all relevant business areas.
Management resources: ensuring the availability of expertise, human resources and financial resources.

Minimum aspects to consider

According to MDR, the QMS must cover a variety of aspects including:

Regulatory compliance: Adhering to conformity assessment procedures and managing product changes.
Risk management: Implementation of a systematic risk management process in accordance with Annex I, Section 3 of the MDR.
Clinical evaluation: Conduct and update clinical evaluations and post-marketing clinical follow-up.
Product realization: Covering all phases, from planning to manufacturing to deployment.
Post-market surveillance (PMS): Building a robust system to collect and analyze market surveillance data.
Communication: Ensuring the exchange of information with authorities, notified bodies and other interest groups.

Importance for manufacturers of Class I products

Although the QMS of Class I manufacturers does not need to be certified, its implementation and ongoing maintenance is critical. It serves as evidence of compliance with regulatory requirements and forms the basis for safe and efficient product development and delivery.

2.2 Requirements of ISO 13485

ISO 13485 is the internationally recognized standard for quality management systems (QMS) in the field of medical devices. It already existed under the Medical Devices Directive (MDD) and forms an essential basis for compliance with regulatory requirements. With the introduction of the MDR, ISO 13485 remains of central importance: A QMS must both meet the MDR requirements and continue to comply with those of ISO 13485.

ISO 13485 focuses on meeting regulatory and customer-related requirements throughout the life cycle of a medical device - from development to market support. The core requirements include:

Risk management: Systematic identification, assessment and control of risks throughout the entire product life cycle.
Process-oriented approach: Structuring the QMS along defined processes that are linked to one another and focused on quality and safety.
Documented procedures: Clear definition and documentation of all essential procedures and processes.

The standard requires a comprehensive system aimed at continuous improvement and compliance with safety and performance standards. The requirements of the standard are therefore divided into different process groups, which together ensure an effective QMS.

Leadership processes

Management processes create the strategic basis for the QMS and contribute to continuous improvement:

Management review: Regular review of the QMS by management to ensure its suitability, adequacy and effectiveness.
Corrective and preventive action (CAPA): Procedures for systematically investigating and correcting nonconformities and preventing future errors.
Internal audits: Scheduled assessments of QMS processes to identify weak points and highlight potential for improvement.

Core processes

Core processes are directly related to the development, manufacture and provision of medical devices, for example (list is not complete):

Change management: Control of product or process changes to ensure that all requirements are still met.
Sales: Control and documentation of the provision of products, including compliance with delivery conditions and regulatory requirements.
Complaints: Handling customer feedback with root cause analysis and evaluation and, if necessary, transferring it to further processes (change management, problem solving)
Purchasing: Purchase of products from suppliers, selection and monitoring of suppliers to ensure that purchased materials or services meet the specified requirements.
Development: Structured planning, execution and monitoring of the development process, including review and validation of product designs.

Support processes

Support processes ensure the basis for the smooth operation of the QMS. This includes z. B. Document steering: It serves to ensure topicality, availability and traceability of all quality -relevant documents. This includes the release, distribution and monitoring of changes in the documentation.

In addition to the MDR, ISO 13485 ensures that a QMS not only meets the MDR requirements, but also offers a proven basis for quality, security and regulatory conformity. Management, core and support processes are closely interlinked and form a robust system that enables manufacturers to meet the high standards of the medical device industry.

3. Requirements of the MDR and ISO 13485 for manufacturers of class I products

Manufacturers of class I products are faced with the task of building a fully extensive quality management system (QMS) that meets both the requirements of the MDR and ISO 13485. Despite the comparatively low risk class of these products, expectations of the structure and implementation of the QMS are not less than with higher risk classes.

An effective QMS requires manufacturers to define, implement and actively live all required processes. This includes in particular:

Management assessment: regular review by the management level to ensure the adequacy and effectiveness of the QMS.
Internal audits: Systematic control and evaluation of internal processes to identify weaknesses and use potential for improvement.

In addition to the basic structuring of the QMS, the operational processes are of central importance, including:

Advanced processing and customer feedback: An effective system for recording, analyzing and processing complaints and feedback, which serves as the basis for improvement measures.
Correction and preventive measures (CAPA): Processes for the analysis of errors, correction of causes and prevention of future problems.
Monitoring according to the placing on the market (PMS): Building a robust PMS system according to MDR articles 83, which also includes the vigilance, i.e. the message and processing of serious occurrences.

The close connection between QMS and technical documentation plays a central role. Data and insights from processes such as PMS, complaint processing and vigilance must flow directly into the technical documentation in order to ensure their topicality and completeness. This is crucial for the continuous conformity of the product with the regulatory requirements.

For manufacturers of class I products, the implementation of the MDR and ISO-13485 requirements means that they have to operate a comprehensive and dynamic QMS as manufacturers of higher risk classes. Active care and the "life" of the system - through regular ratings, internal audits and the consistent implementation of operational processes - is just as crucial as the "armoring" for inspections by the surveillance authorities, which are now carried out regularly at manufacturers of class I products to ensure that all requirements are met here too.

Such a QMS is not certified by the named area, but is regularly inspected by the responsible authority.

4. Conclusion and conclusion

The requirements for a quality management system (QMS) are the same for all manufacturers of medical devices - regardless of their risk class. Manufacturers of class I products are therefore faced with the same responsibility as companies that develop products of higher classes. The requirements of the MDR and ISO 13485 require a full QMS that not only has to be documented but actively lived.

However, a significant difference for class I manufacturers is that your QMS does not have to be certified by a notified area. Although this means saving costs and resources compared to higher -class products, this does not change the obligation to effectively build up the QMS, to regularly check and continuously improve.

Monitoring by authorities remains an integral part of the regulation. Official inspections and the examination of the technical documentation ensure that the requirements are observed. A QMS that not only exists formally but is actively integrated into the processes forms the basis for the permanent conformity and marketability of the products.

For manufacturers of class I products, it is therefore crucial to establish and maintain a functioning QMS. The lack of certification by a named area must not hide the fact that the requirements are comprehensive and must be met in full. A well -structured, actively used QMS is not only a regulatory obligation, but also a decisive factor for the quality, security and success of the products on the market.

5. How we can help you

We are happy to support you with regard to the structure and implementation of your QMS. As an external QMB, we also take over the implementation and the "active life" of the system with their inclusion at QMS for class manufacturers. Because it is not we live the QMS, but you as a manufacturer.

So we support you during your complete project with your medical device, starting with a free initial consultation, help with the introduction of a QM system, study planning and implementation to technical documentation - always with primary reference to the clinical data on the product: from the beginning until to the end.

Do you already have some initial questions?

You can find free initial consultation here : Free initial consultation

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Quality management for Class I medical devices

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