After approval manufactures have to create a post-market surveillance plan (PMS plan) and keep it up to date to ensure appropriate safety measures for patients and users. The PMS plan regulates among other things the clinical post-market surveillance – the post-market clinical follow-up (PMCF). If no PMCF shall be conducted, the PMS plan has to provide a reasoned explanation.
- For innovations
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For devices
- with high risks
- with significant changes
- with a new indication
- with unanswered questions regarding long-term safety and/or performance
- If risks become known in literature or at the surveillance of comparable devices
- For devices, where safety and performance are only proven for a selected group of patients
- If new information regarding safety and performance become known
- If a previously unknown material is used or a known material is used in a different anatomic region of the body
The PMCF covers the continuous and systematic collection of clinical data regarding safety and performance of your medical device in its intended purpose to update the clinical evaluation. This is envisaged over whole product life-cycle.
- to confirm safety and performance over the product life-cycle or detect risks, if necessary.
- to gain long-term experience in routine care
- to evaluate feasibility and acceptance of your device
- to observe chances in the market or user-behaviour and detect weaknesses of your devices
- to verify the acceptability of known risks or to disprove suspected risks
PMCF studies are conducted according to documented, proactive, standardised methods and procedures, which are recorded in the PMCF plan. All relevant information from practice should be considered.
- Continuation of clinical investigations for market approval as follow-up
- New clinical investigations
- Surveillance studies (Data collection under routine conditions)
- Evaluation of register data
- Analysis of relevant retrospective data