MDR and IVDR Quality Management System Requirements
General Background
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.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
The EU MDR and EU IVDR specifies QMS requirements, some of which are described in Article 10, which requires the following:
Key changes that require the manufacturer´s immediate attention:
Many of these requirements should be familiar to any manufacturer that is accustomed to the requirements of ISO 13485. However, there are new requirements under the EU MDR/EU IVDR not covered by ISO 13485. For example, 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
Regarding conformity assessment, the QMS could be assessed according to the scopes specified in EU MDR/EU IVDR Annex IX, X, or XI.
Our Services
Training
The consultants at AKRA TEAM can train your staff to improve their competency with regards to the QMS-specific requirements under EU MDR and EU IVDR. For example, do you understand the requirements for a comprehensive post-market surveillance system that should be established within the boundaries of a QMS, as required by EU MDR Article 83 or EU IVDR Article 78? Are you having difficulty figuring out how a QMS can incorporate EU MDR Article 27 or EU IVDR Article 24, which stipulate requirements for UDI?
Process and Templates Development
Are you creating a new QMS or recertifying under EU MDR or EU IVDR? Your processes are the cornerstone of a solid foundation upon which your company can function, and our QMS experts can help you learn the true intent of key processes and clarify why they matter. With this understanding, you will be able to create and revise your processes so that they are truly effective.
In addition to clarifying specific requirements of the QMS, we will also help you identify mandatory document and records. Using a combination of our experience and our awareness of available guidance documents, our team can help gain a deep comprehension of how to interpret the requirements.
It is also important to enable your team to maintain the effectiveness of the QMS moving forward. Our consultants can teach you how to take a systematic, risk-based approach to implementing and periodically revisiting risk control measures in your QMS so that it continues to function as intended.
Whether you have one process that needs some work or the whole QMS, reach out to AKRA TEAM to get some help developing your QMS processes.
Gap Assessment
Should you want a gap assessment of your QMS, AKRA TEAM can review your QMS processes to produce a baseline or gap assessment of your current level of compliance. We can determine the extent to which you’ve established and documented the QMS in accordance with EU MDR and EU IVDR requirements. We can perform targeted gap assessments focused on key areas of concern, or comprehensive gap assessments on all the entirety of the QMS in relation to EU MDR and EU IVDR.
Implementation
So you’ve gone through some training, written some procedures, and had them reviewed and approved. Now what? To what extent have you trained your teams such that they are able to implement the requirements? AKRA TEAM can support you implementing the new requirements.
Continuous update of documentation
AKRA TEAM can help understand the requirements for continuous updates of documentation, which vary based on the specific area. In general, because EU MDR and EU IVDR have a total product lifecycle approach, many documents are considered “living” and need to be continuously updated.
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