Updated Draft Statutory Instrument for Post-Market Surveillance: Gap Analysis

A new draft statutory instrument for post-marketing surveillance has been published. Our team has conducted a detailed gap analysis to highlight key changes and areas for improvement, especially in comparison with the MDR. Here are the main changes:

• The concept of device lifespan has been removed.
• New clarifications specify that manufacturers with CE Marking are not required to update technical documentation solely as a result of PMS activities. However, relevant data should be included in the rest of the World section of the PSUR for CE.
• The requirement to report similar incidents at the initial report stage has been removed and is now included in the final report stage.