Regulatory Open Forum

MDR Annex IX, 2.1, bullet 6 requires "a documented description of the procedures in place to fulfil the obligations arising from the [QMS] and required under this Regulation and the undertaking by the manufacturer in question to apply those procedures" and bullet 7 "a description of the procedures in place to ensure that the quality management system remains adequate and effective, and the undertaking by the manufacturer to apply those procedures".

Can anyone clarify what is required to meet these, and the similar, requirements, please?  What content and level of detail have you used that has been successful?

Because MDR Annex IX section 2.1 refers to the application lodged with a notified body (NB), then different NBs' applications may have different approaches.  So, ask your NB for a copy of the application so you can see its requirement.

Regarding bullet 6, depending on the NB and the structure of its application, that would generally be at least an overview description (e.g., a list of document names, numbers, type, etc.) of the procedures that you've put in place with respect to Articles 10(9) and 10(10).  Specifically, regarding your procedures for EU MDR regulatory strategy, conformity assessment, CE-marked device change control, addressing GSPR conformity, management responsibility, resource management, supplier/subcontractor controls, risk management, clinical evaluation, PMS & PMCF, product realization, UDI, communication, serious incident reporting, FSCA, corrective and preventive action, and monitoring and measurement.  The NB may also want to know at this stage that you have Quality Manual.

Regarding bullet 7, that would be at least an overview description of your procedures for how you monitor and maintain the effectiveness of your QMS.  The primary procedures for that are internal auditing, management review, QMS monitoring/measurement, and corrective and preventive action.  Thus, there will be some overlap here with some of the procedures already listed for bullet 6.
During the initial application step with the NB, it is unusual to provide full copies of the aforesaid procedures.  But again, you need to see your NB's application to know for sure regarding your particular case.

MDR Annex IX, 2.1, bullet 6 requires "a documented description of the procedures in place to fulfil the obligations arising from the [QMS] and required under this Regulation and the undertaking by the manufacturer in question to apply those procedures" and bullet 7 "a description of the procedures in place to ensure that the quality management system remains adequate and effective, and the undertaking by the manufacturer to apply those procedures".

Can anyone clarify what is required to meet these, and the similar, requirements, please?  What content and level of detail have you used that has been successful?

Thanks Kevin!

In my case, DNV has copied the MDR text verbatim into the application form.  Also, my perception is that they do require full procedure copies by the requirement of bullet 5 or "the documentation on the manufacturer's quality management system".  Please let me know if I have interpreted this incorrectly.  It seems that this might be similar to your reply for bullets 6, 7 and there lies my confusion - redundancy to the procedures themselves.

Because MDR Annex IX section 2.1 refers to the application lodged with a notified body (NB), then different NBs' applications may have different approaches.  So, ask your NB for a copy of the application so you can see its requirement.

Regarding bullet 6, depending on the NB and the structure of its application, that would generally be at least an overview description (e.g., a list of document names, numbers, type, etc.) of the procedures that you've put in place with respect to Articles 10(9) and 10(10).  Specifically, regarding your procedures for EU MDR regulatory strategy, conformity assessment, CE-marked device change control, addressing GSPR conformity, management responsibility, resource management, supplier/subcontractor controls, risk management, clinical evaluation, PMS & PMCF, product realization, UDI, communication, serious incident reporting, FSCA, corrective and preventive action, and monitoring and measurement.  The NB may also want to know at this stage that you have Quality Manual.

Regarding bullet 7, that would be at least an overview description of your procedures for how you monitor and maintain the effectiveness of your QMS.  The primary procedures for that are internal auditing, management review, QMS monitoring/measurement, and corrective and preventive action.  Thus, there will be some overlap here with some of the procedures already listed for bullet 6.
During the initial application step with the NB, it is unusual to provide full copies of the aforesaid procedures.  But again, you need to see your NB's application to know for sure regarding your particular case.

MDR Annex IX, 2.1, bullet 6 requires "a documented description of the procedures in place to fulfil the obligations arising from the [QMS] and required under this Regulation and the undertaking by the manufacturer in question to apply those procedures" and bullet 7 "a description of the procedures in place to ensure that the quality management system remains adequate and effective, and the undertaking by the manufacturer to apply those procedures".

Can anyone clarify what is required to meet these, and the similar, requirements, please?  What content and level of detail have you used that has been successful?