The MHRA recently announced plans to release new requirements later this year for post market surveillance for IVDs for implementation mid-2024 ( if you missed this, you can read about it here in another post of ours here). However this does not mean that manufacturers currently do not have obligations for post market surveillance (also known as PMS).
Even under the IVD Directive, which the UK MDR 2002 references, post market activities are required. Annex III part 5 states:
“The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product.”
This means that as manufacturers you still need to be collecting data on how effective your device is – monitoring your customer complaints and feedback, any incident reporting, your manufacturing information, looking at your trends, to mention just a few possible sources of information. This data should then be reviewed to determine whether any updates are required and if so these actions should be documented appropriately. Potential updates could impact your:
- Risk Management File – Is the Severity of the risks impacted? Does it impact your frequency of occurrence of known risks? Are there new risks that you haven’t included?
- Instructions for Use & Labelling – Do you need to add additional warnings? Are your instructions clear enough?
- Training – Is any training that you provide sufficient? Is additional training necessary for your users?
- Other products – Does the issue impact other devices you manufacture?
Moving forward, we are also wondering what to expect in the new requirements. The consultation response released by the UK government indicates that they want “to clarify and strengthen the requirement for manufacturers to implement a post-market surveillance system”. It is expected that the new requirements will be broadly similar to the requirements for post market surveillance in the IVD Regulation. Good news if as a manufacturer you are also CE marking your device, this is likely to mean that most of the new expected requirements will be in place and when further guidance is shared by the MHRA, your procedure will only require some small adjustments to accommodate any local differences.
Post market surveillance can often feel like a very time-consuming, resource heavy exercise which many manufacturers only complete in order to meet the regulatory requirements. However this is such a waste. As a manufacturer, PMS enables you to collect real-world data of your device being used by your intended users in your intended use environment – data levels which no clinical trial would be able to replicate. This data can then be used to show that your device is still safe and effective, something which all regulatory authorities will be looking for.
So as a manufacturer what should you do next:
- Review your procedure – make sure it aligns with the MHRAs requirements
- Create a PMS plan – ISO/TR 20416 gives great guidance for this
- Determine what data you have available for your device and where that data comes from. Look at the best way for collating and analysing the data you have available
If you need any assistance with your post-market surveillance procedure or creating your PMS plan then IVDeology can help. Book a call here and have a chat with our friendly team.
