Summary of Safety and Clinical Performance

Pitfalls & Solutions

The European Union’s Medical Devices Regulation (EU MDR) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR) have significant quality system requirements for manufacturers of medical devices and in vitro diagnostic medical devices.

To ensure that devices manufactured continue to be in conformity with the requirements EU MDR/EU IVDR and that experience from the use of the devices they manufacture is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance system in place which should be proportionate to the risk class and the type of the device in question.

In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting of incidents and field safety corrective actions.

Any manufacturer of devices of any risk class I to III or class A to D shall establish, document, implement, maintain, keep up to date and continually improve a quality management system. The requirements from EU MDR and EU IVDR are beyond the contents of the well-known and recognized standards ISO 13485:2016 or ISO 9001:2015.

Not only manufactures have QMS obligations under EU legislations. Distributors, importers, health institutions, assembler of systems/procedure packs, re-packers, translation providers and manufactures of parts/components have additional QMS obligations.

Our Service

Process and Templates Development

Gap Assessment

Implementation

Continuous update of documentation

The EU MDR and EU IVDR specifies QMS requirements, some of which are described in Article 10, which requires the following:
a 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
clinical/performance evaluation in accordance with Article 61/ Annex XIV including PMCF (EU MDR) and Article 56, Annex XIII including PMPF (EU IVDR)

product realisation, including planning, design, development, production and service provision
verification of the UDI assignments made to all relevant devices and ensuring consistency and validity of information provided; (EU MDR Article 27(3) and Article 29) (EU IVDR Article Article 24(3) and Article 26)
setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83 (EU MDR), Article 78 (EU IVDR);
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.

here are key areas of the QMS that have additional considerations under EU MDR/EU IVDR QMS:

Clinical investigations
Clinical/Performance evaluation
PMCF/PMPF
PMS (including PMS plan and PMSP/PSUR) and Vigilance
Person responsible for regulatory compliance (PRRC)
Summary of Safety and Clinical Performance (SSCP) or Summary of Safety and Performance (SSP)

EUDAMED
Integration of economic operators
Labelling considerations (including UDI, website, claims, implant card etc.)
Transition provisions