The MDR Quality Management System | Joe Hagan-Brown

A Quality Management System- have you got one? (You probably should have)

The new medical device regulations (EU) 2017/745 (hereafter referred to as MDR), which applied in full from 26th May 2021, introduced a much-needed upgrade to the outgoing medical devices directive 93/42/EEC (MDD). There are many changes introduced by the new regulation including a more stringent classification criteria, an enhanced Eudamed database, clearer obligations on manufacturer, distributors, importers and authorised representatives, enhanced General Safety and performance requirements and of course enhanced traceability requirements including the introduction of UDI.

One of the new requirements which often goes unspoken about is that it is now mandatory for all manufacturers, to have a Quality Management System (QMS). There was no such blanket requirement under the MDD. The requirement for a QMS was reserved for manufacturers of class Is (for sterile aspects of the device), Class Im (for measuring aspects of the device), Class IIa, Class IIb and Class III devices. Under the MDR, every manufacturer, regardless of the class or type of device is legally required to ‘establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with [MDR (EU) 2017/745] in the most effective manner and in a manner that is proportionate to the risk class and the type of device’.

Article 10 section 9 of (EU) 2017/745 goes onto set out the minimum requirements for the QMS which must be established:

‘The quality management system shall address at least the following aspects:

(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;

(b) identification of applicable general safety and performance requirements and exploration of options to address those requirements;

(c) responsibility of the management;

(d) resource management, including selection and control of suppliers and sub-contractors;

(e) risk management as set out in in Section 3 of Annex I;

(f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;

(g) product realisation, including planning, design, development, production and service provision;

(h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;

(i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83; (j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;

(k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;

(l) management of corrective and preventive actions and verification of their effectiveness;

(m) processes for monitoring and measurement of output, data analysis and product improvement.’

Practically this means that all manufacturers need a QMS if they wish to claim compliance to (EU) 2017/745. Whether you manufacture class I, IIa, IIb, III or custom-made devices, as a manufacturer, a QMS is now a mandatory requirement for marketing a medical device under the MDR. More that ever before its worth considering gaining certification to ISO 13485:2016: the international standard which is harmonised to meet the requirements of article 10 and other parts of (EU) 2017/745. 

Whilst it is not mandatory to have an ISO 13485:2016 certificate for your QMS, basing a QMS on the requirements of ISO 13485:2016 and then obtaining certification from an accredited certification body, will provide you and your customers with the reassurance that your products are being designed/manufactured/distributed/serviced/installed in a manner which is compliant with the MDR, leading to more consumer confidence in your products.

The MDR applied in full from 26th May 2021, and as such the requirements above apply in full for any manufacturer claiming compliance to the MDR (EU) 2017/745. Particularly any class I medical device manufacturers who market devices though a self-declaration of conformity of which there are many.

Find out how MedRAS can assist your organisation in establishing a QMS and or gaining ISO 13485:2016 certification