Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
The EU MDR and ISO 13485: Are you compliant?
ISO 13485 and your Quality Management System
The European Union Medical Device Regulation (EU MDR) is a new set of rules that came into force on May 26, 2021, replacing the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).
The EU MDR aims to improve the safety and performance of medical devices in the EU market, as well as to harmonize the regulatory framework across the member states.
The EU MDR introduces many changes and challenges for medical device manufacturers, such as:
- A broader definition of medical devices, including software, accessories, and products without an intended medical purpose.
- A stricter classification system based on risk, intended use, and invasiveness.
- A more rigorous conformity assessment process involving notified bodies.
- A new Unique Device Identification (UDI) system for traceability and transparency.
- Enhanced requirements for clinical data and post-market surveillance.
- Increased responsibilities for economic operators, such as importers and distributors.
- Additional obligations for manufacturers to have a person responsible for regulatory compliance (PRRC) and a quality management system (QMS).
ISO 13485
One of the most widely recognized standards for QMS in the medical device industry is ISO 13485.
ISO 13485 is an international standard that specifies the requirements for a QMS that can be used by any organization involved in the design, development, production, installation, or servicing of medical devices. ISO 13485 is based on the general quality management principles of ISO 9001, but with additional requirements specific to medical devices, such as risk management, regulatory compliance, design control, validation, sterilization, traceability, and customer feedback.
A QMS (Quality Management System) is a set of policies, procedures, and processes that aims to ensure the quality and safety of medical devices throughout their lifecycle. A QMS helps manufacturers to comply with the legal requirements, meet customer expectations, and achieve continuous improvement.
ISO 13485 is not mandatory for EU MDR compliance, but it can be very helpful for manufacturers to demonstrate that they have a QMS that meets the expectations of the regulators, notified bodies, customers, and other stakeholders. ISO 13485 can also facilitate the market access of medical devices in other regions that recognize or require this standard, such as Canada, Japan, Australia, Brazil, and Singapore.
Meeting The Standard
To comply with both the EU MDR and ISO 13485, manufacturers need to follow these steps:
- First, they need to define the scope and applicability of the QMS, identify the type, class, and intended use of the medical devices that are covered by the QMS, and determine which legal requirements apply to them in each market. They also need to establish the roles and responsibilities of the personnel involved in the QMS and document the QMS.
- Next, they need to write down the policies, procedures, and processes that describe how the QMS operates. They need to include the details of each process, such as the objectives, scope, inputs, outputs, activities, resources, controls, verification, validation, monitoring, measurement, analysis, improvement, and records. They also need to use flowcharts or diagrams to illustrate the interactions and interfaces between the processes.
- Finally, they need to implement the QMS by training the personnel on how to follow the QMS procedures and processes, providing adequate infrastructure and work environment for the QMS activities, ensuring that all necessary resources are available and suitable for their intended use, performing risk management throughout the product lifecycle, applying design control principles to ensure that the medical devices meet their specifications and intended purposes, conducting verification and validation activities to confirm that the QMS outputs meet their requirements, maintaining traceability of all relevant information related to the medical devices, and monitoring and measuring the QMS performance.
How to improve the QMS
• When a nonconformity or an undesirable outcome occurs, it is important to implement corrective actions. Corrective actions are actions that aim to eliminate or reduce the causes of the problem and prevent its recurrence. Corrective actions may involve identifying the root cause of the nonconformity, analyzing its impact, selecting and implementing appropriate solutions, verifying their effectiveness, and documenting the results and lessons learned.
• To avoid potential problems or risks, it is advisable to implement preventive actions. Preventive actions are actions that aim to prevent or minimize the occurrence or severity of a potential issue before it becomes a reality. Preventive actions may involve identifying and assessing potential sources of risk, implementing measures to reduce or eliminate them, monitoring their performance, and documenting the results and improvements.
• To continually improve the QMS processes or outputs, it is beneficial to implement improvement actions. Improvement actions are actions that aim to enhance or optimize the quality, efficiency, effectiveness, or customer satisfaction of the QMS processes or outputs. Improvement actions may involve identifying and prioritizing opportunities for improvement, planning and executing improvement projects, measuring and evaluating their outcomes, and documenting the results and best practices.
• To ensure that the QMS documentation reflects the current state of the processes or outputs, it is necessary to review and update the documentation as necessary. The QMS documentation may include policies, procedures, processes, records, manuals, forms, templates, checklists, reports, etc. It should be reviewed and updated whenever there are changes or improvements in the QMS processes or outputs, or when there are new or revised legal requirements or customer expectations. The QMS documentation should also be controlled and maintained in a way that ensures its availability, accessibility, accuracy, completeness, consistency, and security.
By following these steps, and having the appropriate knowledge and experience, manufacturers can establish a QMS that complies with both the EU MDR and ISO 13485 requirements, and that supports their business goals and delivers customer satisfaction.
Further Assistance and Support
Paradigm Shift Consulting Ltd is a UK-based consultancy firm that specialises in GDP compliance and training. We provide advice on how to implement quality management system development, and how to maintain compliance.
We also offer a range of services to help wholesale distributors achieve and maintain GDP standards, such as gap analysis, audit preparation, risk assessment, FMD Requirements, standard operating procedure writing, staff training and mock inspections. Paradigm Shift Consulting Ltd has a team of experienced GDP consultants who have worked with various clients across the UK and Europe.
If you require assistance, advice or a formal consultation of a technical and regulatory nature, call us on 0330 133 0920 for a free initial 5 minute chat. Alternatively, you can email us at info@paradigmshiftconsulting.co.uk or use the contact form at the foot of the page. For general enquiries about access to training courses, email info@gdptraining.co.uk.
Below is a short list of useful links to material associated with this subject.