As a medical device manufacturer, if you are implementing an ISO 13485:2016 certification in South Africa Quality Management System (QMS), you may wonder how the new European Union Medical Device Regulations (EU MDR) affect you, and how your Quality Management System can help with meeting these new requirements. This article will assist to give an explanation for the relationship between these two requirements.

European Union Medical Device Regulations vs ISO 13485

It is essential to word the distinction between these two frameworks. The EU MDR is a regulation released by the European Union that dictates what needs to be done by an organization that desires to manufacture or import medical devices into the European Union. This management includes information on how medical devices need to be marked and certified, along with updates on what information needs to be submitted to the updated Eudamed database, which stores the managerial information for each medical device. In brief, the EU MDR tells you what you need to do to produce medical devices for the European Union market.

ISO 13485 Certification in Qatar, on the other hand, is an internationally identified standard for creating a Quality Management System for medical device organization anywhere in the world. ISO 13485 in South Africa needs can be used by any organization that needs to demonstrate that it produces medical devices and provides related services that consistently meet customer and regulatory needs. Where the EU MDR applies to organizations that sell medical devices in the European Union, ISO 13485 in South Africa applies to any company throughout the world.

European Union Medical Device Regulations Quality Management System

Throughout the EU MDR rules it is stated that manufacturers require to have a Quality Management System in place. This Quality Management System needs to ensure that all medical devices are covered by the QMS rules, that the devices are used under the appropriate QMS processes, and that a panel-market surveillance system is set up and used.

This management system essential to be audited by a notified body, a company that is designated by an EU member state to do assessments of higher-class medical devices, in order to verify the medical devices that are created using the QMS processes. In order for a medical device to be certified, and have an indicating CE mark, the organization must have a QMS in place.

Is ISO 13485 certification in South Africa mandatory for MDR?

ISO 13485 certification in Philippines is not mandatory for EU MDR compliance. However, the European Union Medical Device Regulations regulation requires that you have a QMS in place, even though it does not identify ISO 13485 directly. To aid companies in understanding all of the standards that are applicable for medical devices in the EU, the EU has created a list of harmonized standards, and the ISO 13485:2016 in South Africa standard is the only QMS standard referenced on this list – therefore, most companies use ISO 13485 to implement their QMS.

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