The simple answer is all manufacturers must have a quality management system to comply with the MDR and in compliance with Article 10 (9). However, as with much of the MDR, if only it was that simple.
In an excerpt of Article 10 (9) it states: ‘Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.
And later in the same Article is states: ‘The quality management system shall address at least the following aspects’:
- strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system.
- identification of applicable general safety and performance requirements and exploration of options to address those requirements.
- responsibility of the management.
- resource management, including selection and control of suppliers and sub-contractors.
- risk management as set out in in Section 3 of Annex I.
- clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF.
- product realisation, including planning, design, development, production and service provision.
- verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29.
- setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83.
- handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders.
- processes for reporting of serious incidents and field safety corrective actions in the context of vigilance.
- management of corrective and preventive actions and verification of their effectiveness.
- processes for monitoring and measurement of output, data analysis and product improvement.
In Article 52 (7) Class I Non-Sterile & Non-Measuring devices (except custom-made or investigation devices) shall declare conformity of their devices and issue a declaration of conformity referred to in Article 19 after drawing up the technical documentation in accordance with Annexes II & III.
You should note that the QMS is not mentioned in Annexes II & III and therefore can be reasonably assumed that Class I Non-Sterile & Non-Measuring devices the QMS can meet Article 10 (9) without the need to be assessed by an accredited body or a notified body.
However, for Class I devices that are sterile, measuring or meet the reusable classification the manufacturer shall also apply the procedures in Chapter I & III of Annex IX or Part A of Annex XI.
Chapter I of Annex IX is very clear, the manufacture must establish a QMS as described in Article 10 (9) and the manufacturer shall ensure that the application of the QMS is as specified in section 2 of this Chapter. The QMS must also be audited by a notified body.
The Audit shall determine the QMS meets the requirements referred to in Section 2.2 of Chapter I Annex IX.
Where the manufacturer uses a harmonised standard or a common specification the notified body will assess accordingly to that standard or common specification.
Upon a successful audit the notified body shall issue an EU quality management certificate.
Interestingly, in Part A of Annex XI it mentions that the manufacturer shall lodge an application for an assessment of its quality management system with a notified body, not only that, but it must also be the same notified body that has issued its EU type-examination certificate.
Upon a successful audit the notified body shall issue an EU quality assurance certificate.
In Summary
Manufacturers of non-sterile and non-measuring Class I devices must have a QMS, is does not need to be certificated to any international standards, but it must comply with Article 10 (9) of the MDR.
Manufacturers of sterile, measuring and reusable Class I devices must have a QMS, similarly is does not need to be certificated to any international standards, but it must comply with Article 10 (9) of the MDR. And meet the requirements of Chapter I & III of Annex IX or Part A of Annex XI However, crucially a manufacturer of these devices must lodge an application for their QMS to be assessed by a notified body, after which an EU quality management certificate or an EU quality assurance certificate is issued.
If you do not have the resources internally or locally, remember Advena have a team of consultants who can help, and should you need our assistance please do contact us and we will happily discuss and provide you with a quotation to review your QMS. If you need to implement a new QMS, we can also quote for this.
Email us at: info@advena.mt
