As many of you will already know, the requirements regarding Post Market Clinical follow up and Post Market Surveillance have increased dramatically in recent years. This is not only a result of the changes made within MEDDEV 2.7/1 Rev 4 June 2016 but also Clause 8.2.1 and 8.2.3 of ISO 13485: 2016, and in addition to these the MDR and IVDR have elaborated on these requirements further still.
Considering these changes and in view of the upcoming regulations laid out in Article 88 of the Medical Device Regulation (EU) 2017/745 detailed as:
‘The manufacturer shall specify……. the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan’ – Article 88 Trend Reporting L/117/74 Medical Device Regulation (EU) 2017/745.
We would like to take this opportunity to remind manufacturer’s of their obligations regarding Trend Reporting. Feedback, from production and in post-production, should be analysed to determine ongoing compliance/efficacy and suitability for the product. Trend reporting is utilised to identify if the risk vs benefit analysis for the product has changed. Spikes in foreseeable and unforeseeable hazards, relative to conclusions drawn from risk management, should be recovered and reported as required.
For our Authorised Representative clients, we require not only notification of vigilance incidents but also these trends in reportable and non-reportable events to duly inform the Competent Authorities as they arise.
In accordance with MEDDEV 2.12-1 Rev 8 January 2013 the Manufacturer should already be completing Trend Reports for all products for reportable AND non-reportable events, this should form part of the Post Market Surveillance Plan with links to the Feedback and Risk Management Systems as per the ISO 13485: 2016 and ISO 14971: 2012 standards.
If you require any assistance with the set-up of a suitable post market surveillance/feedback system to ensure these requirements are met, please contact us on firstname.lastname@example.org, to discuss and arrange a quotation.