Description: The concept of sampling of IIa and IIb device technical files was introduced under the 2007/47/EC revision of Directive 93/42/EEC (MDD), and continues under MDR. There has not always been a consistent approach to technical file sampling taken by Notified Bodies under the MDD, but it is expected that this will improve under the MDR. Indeed, a new requirement of the MDR is that the technical documentation of all class IIb (implantable) devices shall be reviewed (exceptions are provided in Article 52), rather than ‘at least one representative device’ per category, or generic device group, for class IIa and IIb (non-implantable) devices, respectively. Whilst a Notified Body selects the samples, and pre-determines the sampling plan, manufacturers can help themselves by working with their Notified Body to provide complete and accurate information to facilitate timely categorisation/grouping to make everyone’s life easier and more transparent. These conversations should have already started with your notified body, and manufacturers should be acutely aware that the requirements for sampling under MDR will result in an appreciable spike in the number of technical documents being sampled during the initial MDR application process, compared to the preceding years during ongoing maintenance of MDD certification. In this session we will discuss various strategies that manufacturers can take which will facilitate categorisation/grouping of their devices contained within their technical documentation, including consideration of novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods. We will also look at scenarios where it may be sensible to combine devices into fewer technical documents, and why the principle of technical file sampling under MDD could leave manufacturers exposed to a great deal of remediation work under MDR if some of the technical files were never reviewed previously by your Notified Body.
Learning Objectives:
Understand representative sampling for class IIa and IIb devices and how it impacts plans to comply with MDR.
Identify opportunities to reorganise technical documentation for device categories/groups in order to better facilitate timely conformity assessment reviews.
