Postmarket Clinical Follow-up Under MDR (On-Demand)

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Postmarket Clinical Follow-up Under MDR (On-Demand)

This is an On-demand recording from June 2022.

The EU Medical Device Regulation (MDR) includes a section dedicated to postmarket clinical follow-up (PMCF) stating it must be a continuous process. Under the previous regulatory system, the Directives, PMCF was considered specific to postmarket clinical investigations, but the MDR takes a new approach to PMCF, encompassing other activities and referring to them as general and specific PMCF.

This webcast will take a close look at the requirements relating to general and specific PMCF activities, cover how to document PMCF plans and reports using the MDCG 2020-7 and MDCG 2020-8 templates, and clarify when justifications for no PMCF are appropriate.

Audience Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Learning Objectives:

After this program, participants will understand:
  • MDR Requirements in relation to PMCF
  • MDCG Guidance documents associated with 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 the interaction with other documents

Who Should Attend:

  • Manufacturers


Richard Holborow

Richard Holborow, BSc (Hons) RCCP MSCST
Global Head of Clinical Compliance Global Regulatory Compliance Team
BSI Group

Richard Holborow is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within 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 with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.


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