The Medical Devices Introductory Course 2020

Post Market Surveillance

Regulatory requirements under MDD 93/42/EEC

Current requirements are dispersed throughout many standards, regulations and guidance documents, lacking specificity

• MDD, 93/42/EEC (Annex II, Point 3.1 Indent 7)

“… shall include an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase , including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action…”

 *Annex X: Clinical Evaluation (incl Investigation)

The Organisation for Professionals in Regulatory Affairs

Post Market Surveillance

• EN ISO 13485, 8.2.1 (Feedback)

“The organization shall establish a documented procedure for a feedback system [see 7.2.3 c - Communication)] to provide early warning of quality problems and for input into the corrective and preventive action processes (see 8.5.2 and 8.5.3)”

• MEDDEV 2.7.1 Clinical Evaluation

“With regard to post market activities, manufacturers are expected to implement and maintain surveillance programs that routinely monitor the clinical performance and safety of the device as part of their Quality Management System”

• MEDDEV 2.12/2 Post Market Clinical Follow Up

“PMCF studies may not be required when the medium/long-term safety and clinical performance are already known from previous use of the device or where other appropriate post-market surveillance activities would provide sufficient data to address the risks”

The Organisation for Professionals in Regulatory Affairs