Regulatory Open Forum

Point (b) of EU MDR Annex II.3 entitled 'DESIGN AND MANUFACTURING INFORMATION' requires an explanation and specification of:

• The manufacturing process along with inclusion of the corresponding pre-launch process qualification/validation studies and data.
• Any manufacturing process aids.
• Manufacturing process and product monitoring and quality control (in-process and final) including any associated validation studies and data for automated monitoring and quality control processes.
• The manufacturing process design and development inputs should also be included or referenced.  This is because of 1) the general context of this section (i.e., "design and manufacturing"); 2) because point (a) is focused on the overall design and development process (which intrinsically includes design and development of the manufacturing process along with the device); and 3) because manufacturing process development information is not otherwise called for by the surrounding Annex II requirements.

Accordingly, EU MDR Annex II.3(b) bears significantly on a contract manufacturing operation.  Consequently, contract manufacturers should expect that the responsible labeled manufacturer will need to be routinely apprised of minor and major process changes so as to assure the process remains in a state of control and that General Safety and Performance Requirements continue to be met.

Hope this helps,

Note also that (though not clearly relevant for a contract manufacturer discussion), product design and development inputs might also be included under point (b) if not already included under point (a) depending on how the Technical Documentation author chooses to arrange the design-related elements of the Technical Documentation.  Still other design deliverables (i.e., risk analysis, outputs, verification, validation, etc.) may also appear here, or at least be referenced, since II.3 is, after all, the overarching design-related section of the Technical Documentation.  For example, the manufacturing process specifications (discussed in my prior post) specifically called for by 3(b) are in fact design outputs and could thus reasonably be included here.  And the product specifications noted by 1.1 are also design outputs, though not so clearly called for (if at all) by II.3(b)'s generic "specifications" label.

The design-related aspect of II.3 (the overarching design-related section of the Technical Documentation) becomes even more cryptic as it makes no direct call for, or reference to, additional crucial design deliverables like risk/benefit analysis, product verification/validation, design transfer, and design change control.  I say cryptic because some of these elements (risk and product v/v) happen to be directly yet separately addressed by surrounding Annex II sections (e.g., 5 and 6), while design transfer and change have no such dedicated sections anywhere in Annex II and thus seem orphaned by II.3's generality.

Point (b) of EU MDR Annex II.3 entitled 'DESIGN AND MANUFACTURING INFORMATION' requires an explanation and specification of:

• The manufacturing process along with inclusion of the corresponding pre-launch process qualification/validation studies and data.
• Any manufacturing process aids.
• Manufacturing process and product monitoring and quality control (in-process and final) including any associated validation studies and data for automated monitoring and quality control processes.
• The manufacturing process design and development inputs should also be included or referenced.  This is because of 1) the general context of this section (i.e., "design and manufacturing"); 2) because point (a) is focused on the overall design and development process (which intrinsically includes design and development of the manufacturing process along with the device); and 3) because manufacturing process development information is not otherwise called for by the surrounding Annex II requirements.

Accordingly, EU MDR Annex II.3(b) bears significantly on a contract manufacturing operation.  Consequently, contract manufacturers should expect that the responsible labeled manufacturer will need to be routinely apprised of minor and major process changes so as to assure the process remains in a state of control and that General Safety and Performance Requirements continue to be met.

Hope this helps,