This is a recording at the request of June 2022.
The European Medical Device Regulation (MDR) includes a section dedicated to post-market clinical follow-up (PMCF) stating that this should be an ongoing process. Under the previous regulatory system, the Guidelines, PMCF was considered specific to post-marketing clinical investigations, but the MDR takes a new approach to PMCF, encompassing other activities and labeling them as general and specific PMCF.
This webcast will take a close look at the requirements for general and specific PMCF activities, explain how to document PMCF plans and reports using the MDCG 2020-7 and MDCG 2020-8 templates, and outline when justifications for no PMCF are appropriate.
Amounts and deadlines
Level of learning of the public:
Intermediate: Content is designed based on the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated skill related to the topic(s). Higher-level concepts are introduced during lectures; exercises of synthesis and/or application of concepts are integrated into the activity.
After this program, participants will understand:
- MDR Requirements for PMCF
- MDCG guidance documents associated with the PMCF
- PMCF plans and how these should be presented
- Types of PMCF activities, including general and specific
- PMCF Reports – How to document your PMCF activities and interaction with other documents
Who should attend:
Richard Holborow, BSc (Hons) RCCP MSCST
Global Head of Clinical Compliance Global Regulatory Compliance Team
Richard Holborow is Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years with the National Health Service (NHS) specializing in implantable cardiac devices and electrophysiology.
Richard joined BSI in 2018, bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved in the Medical Devices Coordination Group (MDCG) working groups for the EU.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for any travel or other costs incurred as a result of the cancellation.
All cancellation requests must be submitted in writing to [email protected] Cancellations will receive a full refund less a 20% administration fee. RAPS is unable to accept cancellations over the phone.
Paid entry substitutions may be accepted with written approval from RAPS for requests received prior to the start of the event. To transfer a registration, send an email to [email protected] with the title of the event, the name of the original registrant and the contact details of the new participant.
Proof of attendance
RAPS will send an electronic letter or a certificate of participation following the webcast.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 a.m. to 5:30 p.m. EST, Monday through Friday) or via email at [email protected]