Is an ISO 13485 certification equivalent to a CE mark for medical devices?
By: Anne Sophie Dil – Co-founder of NAALA
Published on 8 June, 2021
“Our product is certified under the MDR, as we have successfully passed the ISO 13485 audit!” Do such statements sound familiar to you? The Medical Devices Regulation (MDR) and ISO 13485 are often spoken of interchangeably. This is not surprisingly in principle, since both the regulation and the standard mention in their titles that they relate to (the manufacturing of) medical devices.
But is it correct to say that those organizations with ISO 13485 certification comply with the MDR? Does an ISO 13485 certification carry the same value as a CE mark under the MDR?
The MDR stipulates that medical devices may only be offered on the European market if they have a CE mark. ‘CE’ is short for Conformitée Européene, which basically means the product complies to the European legislation applicable to that specific product group. To obtain a CE mark for medical devices, the manufacturer or developer of the medical device must be able to demonstrate that the requirements of the European medical devices legislation, which is the MDR, are met.
For example, the MDR prescribes the safety and performance requirements that the device and its manufacturing processes must meet, as well as that the medical device manufacturer or developer must have appropriate processes in place for quality assurance through a quality management system.
ISO 13485 is an international standard for manufacturers, suppliers and distributors of medical devices. It sets a standard for quality management and is intended to help meet requirements of legislation for medical devices.
Overall, ISO certification helps demonstrate that an organization can continually evaluate and improve its processes, products and services. ISO certificates apply at organizational level, not at product level (whereas the CE mark applies at product level). To obtain ISO certification, the organization must meet all requirements of the ISO standard. The assessment and issuing of certificates is performed by independent external certification bodies. These certification bodies are accredited and monitored by – in the Netherlands – the Council for Accreditation.
ISO certification is not mandatory, so even obtaining an ISO 13485 certification is not mandatory to comply with the MDR. It may nonetheless be helpful to the process of complying with the MDR.
One of the main requirements of the MDR is that the manufacturer must establish and maintain a quality management system. The manufacturer is required to do this in order for the medical device to eventually be CE marked. Such a quality management system, which must be appropriate and proportionate to the risk classification and type of medical device, ensures that the device and the processes for its design and manufacture maintain a high level of quality. Although ISO 13485 certification is not mandatory, acting in line with this standard is recommended to ensure that the quality management system is appropriate.
To finally fully comply with the MDR requirements and be able to place a CE mark on the medical device, the manufacturer must go through a so-called conformity assessment procedure. Depending on the risk class of the medical device, this procedure involves self-certification (Class I) or assessment by an independent third party: a Notified Body (Class IIa or higher). Notified bodies are designated by the European Commission to carry out conformity assessments according to the MDR.
After such a procedure has been successfully completed, the medical device is in compliance with European laws and regulations and may be offered on the European market with CE mark.
Is an ISO 13485 certificate also a certificate of compliance with the MDR? No, but it can be helpful in the process for obtaining a CE mark. The MDR requires an appropriate quality management system. A way of working in accordance with ISO 13485 is often considered “appropriate” under the MDR.
An ISO 13485 certificate issued by an accredited certification body will undoubtedly be valued by a Notified Body designated by the European Commission when assessing the conformity of the medical device, but there is definitely a difference between an ISO certification and a CE mark.
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