Quality Management Systems in the EU MDR
An overview of Quality Management for medical device compliance
What are Quality Management Systems?
The MDR defines Quality Management Systems (QMS) as formalised systems that document processes, responsibilities and procedures to ensure and continuously improve the standard of business activities.
By establishing and implementing a QMS, an organisation defines a standardised set of processes for each business activity. In this way, a QMS ensures that tasks are completed to a specified standard and that individuals within the organisation have a clearly defined set of roles and responsibilities for upholding and maintaining product quality.
What are the MDR requirements for Quality Management Systems?
Article 10 MDR outlines a list of requirements for Quality Management Systems for Manufacturers within the medical device industry. Article 10 requires that manufacturers establish, document, implement, maintain, keep up to date and continually improve a quality management system that conforms to MDR standards. It also requires that the QMS is proportionate to the risk class and to the type of device.
Article 10 calls for manufacturers to have a QMS that covers “…all parts and elements…”
of their organisation, addressing the quality of processes and procedures as well as that of the medical devices themselves.
Article 10 sets out a number of essential aspects that the QMS must address at a minimum. These include a:
- strategy for regulatory compliance
- process to enable identification of all Annex I General Safety and Performance Requirements (GSPRs) that apply to each product, and how they will be addressed
- responsibilities of company management in running the company, ensuring quality standards are upheld, and ensuring maintenance, implementation and upkeep of the QMS
- process for managing resources, including managing sub-contractors and suppliers
- Risk Management procedure
- procedure for performing Clinical Evaluation
- product realisation process, extending from product conceptualisation through development to production and service provision
- procedure for ensuring UDI standards are upheld
- setting up and running a Post-Market Surveillance (PMS) system and Post-Market Clinical Follow-up (PMCF) system for each product
- procedure for handling communications with competent authorities and Notified Bodies
- Vigilance system procedure
- process for measuring and acting upon data relating to product performance and the need for product improvement.
It can be seen from this list of minimum requirements that the Quality Management System requires a documented process for all of the major activities that relate directly to individual medical devices, as well as more general processes relating to the functions of the company as a whole.
How to design and implement an MDR QMS
To assist manufacturers in implementing MDR requirements such as quality management systems, the MDR allows for the use of harmonised standards to guide design and implementation. Adherence to a recognised harmonised standard will lead to a rebuttable presumption of conformity with those aspects of the MDR to which that harmonised standard relates.
The harmonised standard that applies to Quality Management Systems is ISO 13485:2016 - “Quality Management for Medical Devices”. ISO 13485 details a wide range of provisions for building QMSs that cover the majority of requirements relating to quality management in the MDR.
It should be noted that while ISO 13485:2016 is extensive, it was developed in reference to the out-going Medical Device Directive MDD 93/42/EC rather than the MDR. While it addresses most of the requirements for QMS in the MDR there are some areas that ISO 13485 does not cover in enough detail to ensure MDR Compliance. These areas include:
- Requirements for documentation to be produced for each product. The extra requirements imposed by MDR can be found in Annex II - Technical Documentation
- Additional requirements for documents relating specifically to PMS systems, found in MDR Annex III - Technical Documentation for PMS
- Requirements for documented processes relating to Clinical Evaluation
How will a QMS be assessed under the MDR?
A manufacturer’s quality management system will be assessed as a component of conformity assessment procedures specified in MDR Annex IX to XI. For all except Class I devices, conformity assessment will be performed by a Notified Body.
It should be noted that Article 10 MDR requires manufacturers of all medical devices other than investigational devices to develop a QMS to the specified standard, including manufacturers of Class I devices. Although most Class I devices do not require a Notified Body audit, a suitable QMS must still be in place.
Is use of ISO 13485:2016 mandatory?
In short, no. While the majority of manufacturers - especially of Class IIa devices and above - do operate a QMS based on ISO 13485, there is no formal requirement to use this standard. Strictly, the requirements are to adhere to MDR Article 10. However, on a practical level, using ISO 13485 means operating to a standard that is recognised internationally and provides a basis for auditing that will be well understood by Notified Bodies. ISO 13485:2016, then, is likely to be the best choice for most manufacturers.
Looking for help implementing a QMS for your devices? Contact a member of our team to discuss your options for support.
