On Monday, the MHRA laid their enhanced Post Market Surveillance requirements Statutory Instrument before parliament. This SI is one of three planned SI’s amending the UK MDR 2002, to make the legislation effective more than 20 years after its initial publication.
Following BIVDA’s representations, there have been changes from the draft originally put before the WTO. Our regulatory team are reviewing the document and will provide further guidance to members in due course via our usual channels.
You can find the SI here.
