Document and record retention in the EU MDR | Joe Hagan-Brown

The MDR brings stricter requirements on medical device manufacturers in relation to document and record retention. These requirements are within the spirit of the product liability directive 85/374/EEC. The administrative provisions in the  MDR's conformity assessment procedure annexes: section 7 of annex IX and X and section 9 of Annex XI, require the manufacturer to retain and keep at the disposal of the competent authorities a number of key quality management system, and technical documentation… ‘for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market…’

The text of the regulation can be interpreted differently depending on how it is read. It’s important to read and understand the regulation using the definitions it itself assigns in article 2.

‘after the last device has been placed on the market’ The phrase or term ‘last device’, is not defined in the MDR. However the concept of identifying devices uniquely runs throughout the Medical Device Regulation.

Article 2 section 28 explains to us that ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market. The MDR therefore recognises that a device, can in theory be made available on the market more than once. This is to say that the manufacturer first makes a device available on the union market at some point, and then could make the same unique device (identified by LOT or UDI-PI) available again. This making available again may be in the context of reprocessing of a used device followed by its being made available. However reprocessing would not be making the device available for the ‘first time’.

In addition to making a unique device available again (reprocessing), it is also of course the case that new or subsequent, unique LOTs or UDI-PIs or individual units of production of a device model will be first made available.

Article 2 Section 27 establishes that ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge’

When a manufacturer engages in a commercial transaction which involves the supply of a produced device to a third party with a view to distributing, enabling consumption or use of the device within the Union market, it has been made available.

Taking all of the above together and applying them to the document and record retention requirements imposed on manufacturers as regards quality and technical documentation, leads us to a stringent interpretation of the requirements for document retention. Manufacturers are required to retain the key quality and technical documentation as specified in the conformity assessment annexes of the MDR for 10, or 15 years (for implantable devices) commencing from the point in time, or date on which the last unique device produced has been first supplied for distribution, consumption or use.