The EU Medical Device Regulation (MDR 2017/745) placed additional requirements on manufacturers, importers and distributors in an already highly regulated industry.
To help meet the EU MDR and other regulations around the world, many are turning to ISO 13485, the quality management system standard for Medical Devices. But how is ISO 13485 helping?
What is ISO 13485?
ISO 13485 is the internationally recognised standard that sets out the requirements for a Quality Management System specifically for the medical devices industry.
Implementing a QMS to ISO 13485 helps to ensure that products consistently meet customer and regulatory expectations.
The standard ensures processes are in place for the whole lifecycle of the device from design and development, to production, storage, distribution, installation, servicing and even decommissioning.
The standard can be applied to organisations of any type and size. Even if your organisation’s role is only a part of that lifecycle, by ensuring ISO 13485 is embedded throughout the supply chain, you can ensure a quality and safe product.
The EU Medical Device Regulation (MDR): A New Era
In May 2021 the EU Medical Device Regulation (MDR) came into full force, replacing the previous Medical Device Directive (MDD).
Its primary aim is to ensure the safety and performance of medical devices but with the emphasis on patient and user safety.
Among the requirements, the regulations strengthen requirements for clinical evidence, post-market surveillance, traceability and transparency.
The regulations also broaden the definition of “medical devices”:
Any instrument, apparatus, appliance, software, implant, material, or other article intended by the manufacturer for a medical purpose in humans, such as diagnosis, prevention, monitoring, treatment, or alleviating disease, injury, or disability, without achieving its primary action pharmacologically, immunologically, or metabolically.
How ISO 13485 Aligns with EU MDR
The EU MDR lists out the minimum requirements for a quality management system in Article 10(9) of the EU MDR (Regulation (EU) 2017/745), all of which can be met through a well implemented ISO 13485 QMS.
So, although it is not mandatory to implement ISO 13485 in order to comply with the regulations, it can help.
Key areas where ISO 13485 can help compliance:
- Core Quality Management Framework: The standard sets out a cycle of continual improvement through the policies and procedures of the system.
- Risk Management: The standard mandates a risk-based approach throughout the product lifecycle, which can incorporate and align to MDR requirements.
- Design and Development: ISO 13485 sets out the requirements of design, development planning, verification, validation and change control.
- Supplier and Outsourcing Controls: A core part of the MDR, ISO 13485 ensures processes for selecting and monitoring suppliers and outsourced services.
- Post-Market Surveillance and Vigilance: The standard’s requirements for feedback, compliant handling and processes for reporting to regulatory authorities all support the MDR’s emphasis on post-market monitoring and incident reporting.
Get Started with ISO 13485 and Comply with EU MDR
It’s important to recognise that while ISO 13485 provides a strong foundation, it does not cover all aspects of MDR alone, even if you have achieved ISO 13485 certification.
Some examples of areas not explicitly covered in the standard include Unique Device Identification (UDI), EUDAMED registration and enhanced clinical evaluation.
However, by working with an expert medical devices consultant, such as those at Assent, we can help you build all the additional requirements of the MDR into a single QMS built on ISO 13485.
Contact our ISO 13584 Consultants to discuss your compliance needs and start your journey towards certification and EU MDR compliance.
