Post-market Clinical Follow-up for Medical Devices
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| Level: |
Foundation
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Area: |
Medical Devices
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| Code: |
MDF4
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Duration: |
03:30:00
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| Workshop profile: |
| This course is intended for medical writers with little or no experience in regulatory writing, including Post-market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports, under the Medical Devices Regulation 2017/745 (EU MDR). There is no prerequisite to attend this workshop but basic knowledge of clinical research and medical device terminologies will be useful. |
| Objective: |
| With the introduction of the Medical Devices Regulation 2017/745 (EU MDR), each device (or device family) needs a specific PMCF Plan. The results of PMCF activities are summarized in a PMCF Evaluation Report. These documents are subject to predefined review cycles and depend on several other input documents. This course will give you profound insights into the regulatory requirements for PMCF, best practice recommendations on how to prepare PMCF Plans and Reports, and insights into common pitfalls and tips on how to avoid them. |
| Content: |
| The course includes an introduction to:
· Annex XIV Part B of EU MDR 2017/745 (Post-Market Clinical Follow-up)
· MDCG (Medical Devices Coordination Group) Guidance on PMCF Plans (2020/7)
· The MDCG (Medical Devices Coordination Group) Guidance on PMCF Evaluation Reports (2020/8)
· Input documents and review cycles
· Different methods to conduct PMCF.
You will work with a fictional medical device to think about general and specific PMCF activities. You will also get insights into what triggers PMCF and how to avoid common pitfalls related to PMCF documentation. |
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