An Approach to PMS and PMCF for SaMD Startups

Medical Device Software (MDSW) (“Software”) developed by Medical Device (SaMD) startups, plays an important role in driving innovation in the MedTech industry, despite often having limited resources. This is especially true in highly novel applications such as cloud-based software dependent upon artificial intelligence and machine learning. Due to the limited availability of clinical data, performing clinical evaluations as a SaMD startup can be challenging. In such scenarios, a robust approach to Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) for SaMD startups becomes even more critical.

How to approach PMS and PMCF as a SaMD startup

In this article, we present considerations to be considered for a practical approach to PMS/PMCF for such devices and manufacturers. 

MDSW/SaMD data considerations regarding PMS/PMCF

As established under Article 83 of the MDR, manufacturer PMS systems must be appropriate for the manufacturer to actively and systematically gather, record and analyze relevant data on the quality, performance, and safety of a device throughout its entire lifetime, to draw necessary conclusions, and to determine, implement and monitor any preventive and corrective actions, in particular to: 

• • Update the benefit-risk determination and improve risk management 
  • Update the design and manufacturing information, instructions for use, and labelling 
  • Update the clinical evaluation 
  • Update the summary of safety and clinical performance (SSCP) 
  • Identify needs for preventive, corrective, or field safety corrective action (FSCA) 
  • Identify options to improve device usability, performance, and safety 
  • Contribute to the PMS of other devices, when relevant 
  • Detect and report trends 

Such data may include but is not limited to, complaints, PMCF data direct end-user feedback, newly published research/guidelines, and real-world performance data. 

Manufacturers of MDSW/SaMD , in particular cloud-based software, are uniquely positioned compared to traditional device manufacturers such as manually operated surgical instruments, given the connectivity/access to real-world performance data, which for PMS and PMCF may be used for several purposes, including (but not limited to): 

• • Detection and correction of malfunctions (remembering to comply with MDR FSCA requirements when making corrections) 
  • Detection of systematic misuse and taking actions to address misuse, such as implementing software controls and/or providing information to users (remembering to comply with design change and risk management controls when determining and implementing such changes/risk controls) 
  • Reviewing user interactions and behavior during device use (and comparing this data with original usability data, as well as design and risk controls to identify the need for any changes) 
  • Monitoring clinical performance (and comparing this performance with pre-market clinical studies and clinical performance claims made in the IFU and verifying whether conclusions made in the CER continue to be valid) 
  • Identification of potential future design changes to the device, such as the addition of new functionality and intended use(s) 

Cloud-based MDSW/SaMD also facilitates manufacturer conformity with MDR trend reporting requirements, which may be extended to hardware-based devices intended to be used in combination with MDSW/SaMD. One such scenario could be a cloud-based sleep apnea monitoring/diagnostic MDSW/SaMD, that is used in combination with a hardware-based sensor that includes accelerometer-based positionality data which may be collected from different locations of the patient’s body. Data provided to the MDSW/SaMD could include the location where the sensor(s) was/were fitted to the patient and the quality of data output by the sensor(s). 

It is strongly recommended that manufacturers consider how they will strategy real-world performance data to get the most out of it, before launching it onto the market. 

MDSW/SaMD data privacy and cybersecurity concerns regarding PMS/PMCF

While its fine (and reasonable) that real-world performance data is used for the above purposes within the framework of a manufacturer’s PMS process, care still needs to be taken when handling data that could fall within the scope of privacy legislation.  

In the EU, the EU Charter of Fundamental Rights stipulates that EU citizens have the right to protection of their data, with Regulation (EU) 2016/679 (i.e. the General Data Protection Regulation (GDPR)) establishing the protective measures of natural persons about the processing of personal data and on the free movement of such data. 

Therefore, start-ups that are manufacturers of cloud-based MDSW/SaMD should ensure that data processed for PMS/PMCF is done so without breaching the requirements of the GDPR.

Furthermore, with the great power that comes with obtaining real-world performance data through MDSW/SaMD connectivity comes great responsibility. The EU has made great strides in strengthening its cybersecurity regulatory framework under the EU Cybersecurity Act and manufacturers should ensure ongoing conformity with reportability requirements under the act and be aligned with current guidance on cybersecurity for medical devices under MDCG 2019-16. 

Reach out to MedEnvoy for more information on PMS and PMCF

If you have any questions regarding MDSW/SaMD, PMS, or PMCF or require relevant training/consulting services, get in touch. 

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  • Understanding Clinical Performance Reports(CPR) under the IVDR: A Guide for IVD Manufacturers

Learn more about MDSW and SaMD

Medical Device Software (MDSW) including Software as a Medical Device (SaMD) is rapidly transforming healthcare delivery. The regulatory framework for SaMD in the EU is primarily governed by the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). For a more information on MDSW and SaMD we have compiled an in-depth comprehensive guide on the subject. Click here for more information.