The requirements for the Manufacturer’s Quality Management System (QMS) are contained in Article 10, 9. Those familiar with the EU’s medical device QMS standard, EN ISO 13485:2016, should immediately recognise the similarities with Article 10, 9. On this page “the Standard” means EN ISO 13485:2016. At the time of writing an update of Annex Z of the Standard, the explanation of the relationship between the Standard and the Regulation, is still anticipated. Nevertheless, one can see that the QMS requirements in the regulation largely correspond to the sections of the Standard. However, in addition, the authors of the EU MDR have highlighted some specific EU requirements items which must be present for the QMS to be EU MDR compliant.
The first half of paragraph 1 of Article 10, 9 is concerned with change management. The Manufacture’s QMS must ensure that devices in production remain in conformity. Changes, whether they be changes to the design or changes to harmonised standards must be addressed in a timely manner. One could argue that the Standard already requires this in 7.3.9 “Control of design and development changes”, but since the EU MDR specifically highlights this point it’s worth considering having a specific procedure to address the handling of changes, including changes to European standards and the updating of the EU Declaration of conformity. The second half of paragraph 1 requires the establishment of a documented QMS. This requirement should be satisfied by fulfilling Section 4 of the Standard on the "Quality management system". However, the last sentence of paragraph 1 removes some discretion when interpreting clause 4.1.2 b) of the Standard. The risk based approach adopted for the controls, has to be consistent with the risk class of the device being produced.
Paragraph 2 of Article 10, 9 defines the scope of the QMS which, according to 4.2.2 of the Standard, has to be documented in the Quality Manual.
Concerning those specific requirements for the Manufacturer's QMS that are listed:
(a) Fulfilment of 4.1.1 of the Standard “…any requirement, procedure, activity or arrangement required to be documented by applicable regulatory requirements” must include the requirements from the following articles of the Regulation: Article 15 Person responsible for regulatory compliance, including the solutions adopted to ensure compliance, Article 52 Conformity assessment procedures and Annex VII 4.9. Changes and modifications (to devices certified by a Notified Body).
(b) Fulfilment of 7.2.1. c) of the Standard “applicable regulatory requirements related to the product” must include fulfilling the requirements of Annex I of the Regulation.
(c) Should be satisfied by fulfilling Section 5 of the Standard on “Management Responsibility”,
(d) Should be satisfied by fulfilling Section 6 of the Standard on “Resource Management”,
(e) Fulfilment of 7. 1. of the Standard “The organization shall document one or more processes for risk management in product realization” must include fulfilling the requirements for risk management in Section 3 of Annex I of the Regulation,
(f) Fulfilment of 7.2.1. c) of the Standard “applicable regulatory requirements related to the product” must also include fulfilling the requirements for clinical evaluation as specified in Article 61 and Annex XIV of the Regulation,
(g) Should be satisfied by fulfilling Section 7 of the Standard on “Product realization”,
(h) Fulfilment of 7.2.1. c) of the Standard “applicable regulatory requirements related to the product” must also include fulfilling the requirements for verification of UDI assignments as specified in Article 27 (3) and Article 29 of the Regulation,
(i) Fulfilment of 8.2.1. of the Standard “Feedback” must include fulfilling the requirements for a post market surveillance system as required by Article 10, 10 and specified in Article 83 of the Regulation,
(j) Fulfilment of 8.3.3. of the Standard “Actions in response to nonconforming product detected after delivery” must also include fulfilling the requirements for stakeholder communication consistent with Article 10, 12,
(k) Fulfilment of 8.2.1. of the Standard “Feedback” must also include fulfilling the requirements for reporting of serious incidents and field safety corrective actions as required by Article 10, 13 and specified in Articles 87 and 88 of the Regulation,
(l) Should be satisfied by fulfilling sub-sections 8.5.2 and 8.5.3 of the Standard on “Corrective action” and “Preventive action”
(m) Should be satisfied by fulfilling Section 8 of the Standard on “Measurement, analysis and improvement”.