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Happy 1st Birthday, EU IVDR date of application!

It’s officially a year after the date of application (DoA) for the EU IVDR, and although there are transition dates for the legacy devices, the requirements for post-market surveillance (PMS), market surveillance, vigilance, registration of economic operators and of devices have been in place since the DoA – 26th May 2022. 

Therefore, there is a need for manufacturers to comply with the Post Market Surveillance obligations for ALL CE-marked products now.

So, what does this mean for me today? 

All manufacturers of CE-marked devices must have a PMS procedure within their QMS that aligns with the requirements established in Articles 78 to 81, Annex III and Annex XIII Part B. The procedure should link to the relevant procedures for Risk Management, CAPA and Performance Evaluation.

A PMS Plan must be created for each of your devices (according to Annex III). This should include:

  • what data you will be collecting for your device – data such as complaints, adverse events, trends, production information, literature searches, feedback from users, importers & distributors; how frequently will you be collecting the data,
  • how you plan to analyse the data collected – what methods you will use, who will complete the analysis.
  • what you will then do with the results – reassessment of the benefit-risk analysis, investigations, determining the need for any CAPAs or communication with customers, Competent Authorities, Notified Bodies and Economic Operators.

It should include proactive data collection, such as from customer surveys, not only relying on data from complaints and trends. It should also include a Post Market Performance Follow-up Plan (according to Annex XIII Part B) or a justification as to why this is not necessary. 

The plan should also include the frequency of review required. For Class A & B, you can justify the frequency of PMS reporting based on the risk of your device. For Class C and D CE-marked products, the requirement is for PMS to be carried out annually and therefore the first ANNUAL review will be coming up! 

For Class A & B devices the outcome of the Post Market Surveillance will be documented in a PMS Report (according to Article 80) where the results are summarised together with the conclusions drawn and any actions required are documented. For Class C & D, the outcome of the PMS will be documented in a Periodic Safety Update Report (PSUR) (according to Article 81), unless they are still currently CE marked under the IVDD where under the transition, according to the published guidance MDCG-2022-8 on legacy devices, a PMS report is the minimum requirement for these devices unless a manufacturer voluntarily prepares a PSUR. The PSUR, in addition to the results, conclusions and actions required by the PMS Report, also includes the conclusion of the benefit-risk determination, the findings of the PMPF and volume of sales, estimation of the size and characterisation of the population using the device and the usage frequency.

So, what should I do next?

  • Make sure that you have the relevant procedures and templates in place to meet the IVDR requirements for PMS.
  • If you are a manufacturer of a Class A or B device, ensure that you have a PMS plan in place for all your devices and that you are collecting the data that you have determined within the plan is appropriate.
  • If you are a manufacturer of a Class C or D device, start preparing for your first PMS review and creating the required report for your device.

If you want to know more or feel that IVDeology could help, then book a call with Casey here