Manufacturers can benefit from the extended transitional period for legacy devices under certain conditions. One being to have set up a Quality Management System (QMS) in accordance with Article 10(9) MDR by May 2024. Non-legacy device manufacturers should have had a compliant QMS in place from May 2021 (applicable to all device classes, including Class I).
We outline below the components of an MDR compliant Quality Management System:
- A Quality Manual
- A Regulatory Strategy document
- Identification of applicable general safety and performance requirements
- You can find an specialized MDR checklist in our MDlaw store.
- Indication of management responsibility
- Indication of resource management
- Including the selection and control procedures of suppliers and sub-contractors.
- PRRC related documentation
- You can find templates for a PRRC job description & designation letter in our Store.
- Risk management
- Procedure outlining risk management plan, report, etc.
- Procedure on Clinical Evaluation, including a Post-market Clinical Follow-up (PMCF)
- You can find related documents in our Clinical Evaluation section.
- Product realization of the device, stating:
- Service provision
- Procedure on UDI assignment & records keeping
- You can find related documents in our UDI section.
- A Post-market surveillance system (PMS)
- You can find related documents in our Post-market surveillance section.
- Procedure to handle communication with competent authorities, notified bodies, other economic operators and stakeholders.
- Procedure for reporting of serious incidents and field safety corrective actions
- Procedure for the management of corrective and preventive actions and verification of their effectiveness
- Procedure for monitoring and measuring of output, data analysis and product improvement & final product release
Finally, please also note the standard ISO 134835 is harmonized under MDR, providing presumption of conformity as well as guidelines.
Do you need assistance with your QMS? Do not hesitate to contact us!