Question

Requirements and references

• Chapter VII Articles 83–89
• Annex III 1(a) and (b)

MDF reference

MDF4550 §3.3.1

Question

Requirements

• Chapter VII Articles 83-89 describe the requirements for post market surveillance and vigilance
• Annex III 1 (a) and (b)

Observation

It remains unclear how all of the requirements of the referenced Annexes and Articles have been met.

For example (not exhaustive):

• SOPs with sufficient detail to demonstrate effective and appropriate methods and processes to assess the collected data are not found
• Specific and suitable indicators and threshold values to be used in the continuous reassessment of B/R and risk management are not found
• Detail on effective and appropriate methods and tools to investigate complaints and analyze market-related experience from the field per Article 87 (sub-clauses 1, 2, 7, 8, 9 and 11) is not found
• Details of specific methods of trending to manage the trend report per Article 88 is not found
• Methods and protocols to communicate effectively with all relevant bodies is not found
• Procedures detailing how the requirements of Articles 83 and 86 are not found (e.g. SOPs describing how requirements will be met)
• Systematic procedures to identify and initiate appropriate measures and trace and identify devices for which corrective actions are needed do not seem to be detailed.

Request

Please address all points above. Please provide traceability to how the plan meets the requirements for each point of Annex III 1 (b) and referenced requirements (such as Annex XIV 1 (a) and Article 83, 86, 87, 88). Please provide all relevant WIs/SOPs and page/section references to where the requirements have been met.