Essentials of European Medical Device Regulatory Affairs

Prepare technical documentation • Technical “File” NB-MED 2.5.1Rec5Rev4 or GHTF STeD – Product description – General Information include accessories, classification with rule, conformity assessment route chosen – List of Standards used to demonstrate compliance – Essential Requirements Checklist – Risk Analysis – Clinical Data – Labelling including Instructions for Use – List of manufacturing sites – what is made where including subcontractors – Manufacturer name and address + Authorised Rep (if applicable) – Declaration of Conformity

Prepare technical documentation • - Technical File Contents

Test and verification reports

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– Design history from the QMS especially validation reports – Product specifications / drawings from raw materials to finished product – Description of, or reference, to manufacturing processes and procedures – Subcontractor details – Product inspection / release procedures

MDR Defined by Annexes 2, 3, 4, 14 and 15