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Implementing and maintaining a Quality Management System (QMS) is mandatory to launch medical devices in the global markets. Having an effective QMS should embody all the procedures and processes covering all aspects from design to production, packaging and distribution. It must become a continuous pursuit for every medical device organization to update their QMS, as per the directives set forth by the global Regulatory Agencies.
Failing to implement an effective QMS will revoke the device certification and the device cannot be legally sold in the countries where certifications are needed. Having an effective QMS alone will not suffice; there are a number of EU MDR and IVDR updates and requirements for medical devices and their QMS, which are mandatory for marketing medical devices in the EU region. Here we give you some of the key QMS requirements for EU MDR and IVDR mandates.
EU MDR QMS Requirements: Unlike the Medical Device Directive (MDD), the EU MDR promotes a life-cycle approach to medical device regulation and the QMS should address:
- Management responsibility and resource management
- Regulatory compliance strategy, which includes compliance with conformity assessment procedures and procedures for the management of device modifications
- Section 3 of Annex I for risk management
- Identify the applicable general safety and performance requirements and explore the options to address those requirements
- Product realization - planning, design, development, production and service provision
- Article 61 and Annex XIV for clinical evaluation, including post-market surveillance follow-up (PMPF)
- Article 83 for setting-up, implementation and maintenance of a post-market surveillance system
- As per Article 27(3), verify UDI assignments to all the relevant devices and ensure consistency and validity of the information provided is in accordance with Article 29
- Handling communication with notified bodies, competent authorities, other economic operators, customers and/or other stakeholders
- In the context of vigilance, processes for reporting serious incidents and field safety corrective actions
- Manage Corrective and Preventive Actions (CAPA) and verify their effectiveness
- Processes for product improvement, monitoring and measurement of output and data analysis
EU IVDR QMS Requirements: This regulation includes new requirements for risk classification, conformity assessment procedures and clinical evidence, which are to be managed within the manufacturer’s quality system and should address the following aspects:
- A Regulatory compliance strategy, which includes compliance with conformity assessment procedures and procedures for the management of modifications to the devices covered by the system
- Identify the applicable general safety and performance requirements and explore the options to address those requirements
- Management responsibility and resource management, including selection and control of suppliers and sub-contractors
- Section 3 of Annex I for risk management
- Article 56 and Annex XIII for performance evaluation, including PMPF
- Product realization - planning, design, development, production and service provision
- As per Article 24(3), verify the UDI assignments to all relevant devices and ensure the consistency and validity of the information provided is in accordance with Article 26
- Article 78 for setting-up, implementation and maintenance of a post-market surveillance system
- Handling communication with notified bodies, competent authorities, other economic operators, customers and/or other stakeholders
- In the context of vigilance, processes for reporting serious incidents and field safety corrective actions
- Manage CAPA and verify their effectiveness
- Processes for product improvement, monitoring and measurement of output and data analysis
In addition to the above-mentioned, there are several requirements for the post-market surveillance, safety and performance summary reports, quality system SOP updates for Periodic Safety Update Report (PSUR), Incidents and Field Safety Corrective Actions (FSCA), Unique Device Identification (UDI), labeling and supply chain. With all these aspects stand as critical for EU MDR and IVDR, have you evaluated your preparedness for compliance? Do it now with a regional Regulatory expert. Stay informed. Stay compliant.
