Module 17 2024

05/12/2024

Chapter 6: Conformity Assessment

Prohibit manufacturers from lodging parallel conformity assessment applications with more than one Approved Body for the same assessment Set out a requirement in regulations that Approved Bodies must specify within their internal procedures a time limit to respond to a conformity assessment application Require manufacturers to declare whether they have withdrawn an application with another Approved Body prior to the decision of the Approved Body they have applied to and provide information about any previous application for the same conformity assessment that has been refused by another Approved Body Require Approved Bodies to inform other Approved Bodies and the MHRA of any manufacturer that withdraws its application prior to the Approved Body’s decision regarding the conformity assessment. Specify the required structure of a manufacturer’s technical file for a medical device

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The new regulations will increase the document retention timescales for implantable devices to the expected lifetime of the device or at least 15 years after the last product has been manufactured. Similarly, for non-implantable devices, the timescale for document retention will be increased to the expected lifetime of the device or at least 10 years after the last product has been manufactured. Certificates of Conformity (UKCA Certificates) The minimum content of Certificates of Conformity will be detailed within the regulations. The regulations will also allow Approved Bodies to impose restrictions of a medical device to certain groups of patients or require manufacturers to undertake specific post-market clinical follow-up or post-market performance follow-up studies. Chapter 6: Conformity Assessment

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