Cardiac Implantable Electronic Devices – MHRA Recommendations for Pre-and Post Market Clinical Studies

At present, CE marking has been obtained for leadless pacemakers however, there is limited clinical data, with small patient numbers and short timescales. The Medicines and Healthcare products Regulatory Agency (MHRA) set up the Expert Group so that they could provide clinical guidance on the use of leadless pacemakers combined with more robust surveillance of safety, to ensure that this new technology is used appropriately in order to decrease the risk to patients. The MHRA has released the initial recommendations of the Expert Advisory Group on pre- and post-market clinical studies for leadless pacemakers.

To read the MHRA recommendations, please click here.

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Published on 23. March 2017 in News UK