Guidance

Leadless cardiac pacemaker therapy: guidance from an MHRA Expert Advisory Group

Recommendations on leadless cardiac pacemaker therapy from MHRA Expert Advisory Group

• From: Medicines and Healthcare products Regulatory Agency
• Published: 13 March 2017
• Last updated: 28 January 2021
  Show all updates

  1. 28 January 2021

     An updated PDF has been uploaded that includes changes to regulations following the Brexit transition.

  2. 23 November 2018

     Minor changes to reflect clinical experience gained over the last year, including: operator experience and implant surveillance; additional recommended minimum sample sizes and follow-up durations; recommendations on implanting centre selection.

  3. 13 March 2017

     First published.

Documents

Leadless cardiac pacemaker therapy: design of pre- and post-market clinical studies

PDF, 630 KB, 12 pages

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Details

In 2015 the MHRA’s Devices Expert Advisory Committee (DEAC) commissioned the Expert Advisory Group on leadless cardiac pacemaker devices.

The group was tasked with producing a framework document aimed at manufacturers and notified bodies to cover best practice in:

• pre-market clinical evaluation of current and planned devices, including advice on pre-market clinical trial design

• post-market clinical evaluation of current and planned devices and evaluation of data gathered in the post-market phase.

This guidance applies to new devices and all design changes or iterations and enhancements that might affect the clinical safety or performance of the leadless device. It provides advice on general statistical principles which can guide decisions in designing and conducting the study.