Medical Device Regulation Supporting Safer Development

In our previous blog on the Medical Device Regulation (MDR) we focussed on how the MDR will support safer product development. In this blog we look at the alignment of the MDR with best industry practice and the current maze of medical device standards.

The MDR Annex II on Technical Documentation provides a comprehensive guideline on the necessary technical documentation. It also brings topics such as benefit-risk and risk management to the fore, with Section 6.1 on pre-clinical and clinical data generating a good summary of topics such as electromagnetic compatibility, safety and software.

Where potentially there is a disjoint here is the increasing tendency to treat software as a separate topic. Much has been discussed about stand-alone software in recent years and standards such as IEC 82304-1 are extremely helpful documents.  However, this approach can also encourage teams to treat software as a stand-alone entity, when in most cases it will be an integral part of an Electronic Programmable System which, although well defined in Annex I clause 17, could also have been listed in Annex II on Technical Documentation. This again brings to light the lack of clarity for approvals of complex electronic systems where the integration of hardware and software is a key activity.

The topic of Electronic Programmable Systems does highlight the assessment of single fault conditions, hence guiding on the level that fault analysis needs to go. The favourite topic of the last few years, cybersecurity, is also introduced in Annex I clause 17 under the titles of information and IT security. Documents such as the ANSI/AAMI TIR 57:2016 take the topic of cybersecurity much further, as is appropriate, but the MDR is now introducing security as a topic.

In summary the MDR is focussing teams on the key activities for medical device development but there is still scope to enhance the information available.