Clinical Studies in PMCF

You can register for this Pre-Conference workshop until Friday 23 October via the RAPS Euro convergence website: https://www.raps.org/europe-2020/register. Once you have registered you will receive an email with the webcast link for the meeting.
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One of the biggest challenges posed by the EU MDR is the requirement to substantiate market access of medical devices with ’sufficient' clinical data.
Manufacturers ask themselves the question: How can I effectively and cost-efficiently obtain the required clinical data? Clinical data derived from medical devices already on the market can be an important source. This session will give you the background and insight to decide in what cases a Post Market Clinical Investigation will be a suitable source of clinical data. The session will also explain the design and the legal requirements and procedures for Post Market Clinical Investigations in the MDR.

8h30-10h00 Block 1*: Theoretical introduction on PMCF requirements
- MDR (text and annexes; including PMCF in relation to clinical evaluation requirements)
- MDCG Guidance 2020-6 (Legacy devices)
- MDCG Guidance 2020-13 (CEAR) Part F

10h00-10h30 Coffee break

10h30-12h00 Block 2*:PMCF-scenarios
-Clinical investigations (cf.MDR art 74.1)
-Surveys
-Other methods

12h00-12h30 Lunch break

12h30-14.00 Block 3*:PMCF Practical exercises
Participants will apply the theory of blocks 1&2 to hypothetical medical devices and will design a PMCF strategy for these hypothetical devices.

14h00-14h15 Short break

14h15-15h15 Block 4*: PMCF Planning and execution
-Planning of the activities resulting from Block 3
-Reporting to NBs: when to report what

15h15-15.30 Final Q&A