CEN ISO/TR 20416 – A useful update for your PMS Process

CEN ISO/TR 20416 – A useful update for your PMS Process

Technical Committee ISO/TC 210 (Quality management and corresponding general aspects for medical devices) recently published a technical report (guidance) to ease the pain of incorporating post market surveillance into manufacturer’s quality management system.

This guidance describes proactive and systematic approach towards PMS process so that manufacturers are well-trained for collecting and analyzing appropriate data in order to meet EU MDR requirements. Despite the one-year push back to EU MDR compliance timelines, many challenges still exist when it comes to implementing PMS process – i.e. coming up with satisfactory data collection and data analysis tools and cross-linking the results with never-ending list of ‘other processes’.

Don’t worry! You’ve come to the right place in case you are hoping for getting a quick overview of the Technical Report. Keep reading!

First of all, this technical report is consistent with relevant international standards, especially ISO 13485 (Quality Management) and ISO 14971 (Risk Management) and the requirements are complimentary to above-mentioned standards for production and post-production activities to conduct PMS effectively. Second of all, this report introduces no additional requirements than what’s already covered in EU MDR.

This 43 pages long document starts with explaining the scope and purpose of PMS. The main focus of this document is PMS Plan – a precursor to documenting your results.

This guide thoroughly talks about the general idea of PMS plan, its scope and objectives, allocation of responsibilities to appropriate authorities, data collection and data analysis methods; it talks briefly about PMS review!

In addition, TR 20416 includes three annexes with informative examples of:

  • Data sources (i.e. PMS Input)
  • Data analysis methods (i.e. PMS Output)
  • Examples of PMS Plans for surgical scalpel, radiation therapy system, drug eluting stent, blood-glucose monitoring system, large IVD analyser.

Last but not least, the report stresses on the importance of PMS interference with other processes like design & development, risk management, clinical evaluation etc. It also considers PMS information as an input to the management review.

WE, at ALCEON can help you with:

  • Preparing PMS and PMCF Plans and Reports
  • Reviewing your existing PMS/PMCF Plans and Reports
  • Answering questions that you may have related to PMS and its implementation

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