The entry into force of the Regulation (EU) 2017/745 on devices medical (Mdr) and the Regulation (EU) 2017/746 on devices ( medical diagnosticin vitro Ivdr) introduced a set of regulatory requirements on post-market surveillance (Pms), whose obligations all manufacturers of medical devices and in vitro diagnostic devices are required to follow, with the aim of ensuring a high level of safety and performance of devices placed on the EU market.
The post-marketing surveillance process
Pms is a continuous and systematic process for manufacturers in collaboration with other economic operators to collect and analyze data on the quality, safety, and performance of their devices on the market throughout their lifecycle in order to identify any needs for immediate corrective or preventive action.
What the regulation stipulates
Both regulations require the implementation of a Pms management system, proportionate to the risk class and appropriate to the type of device, for the systematic collection and analysis of post-marketing data.
Article 83 of Mdr and Article 78 of Ivdr also outline in detail the role of Pms data, specifying that they are to be used in particular for the following purposes:
- Update the risk-benefit assessment and improve risk management as outlined in Annex I, Chapter I;
- Update design and manufacturing information, operating instructions and labeling;
- Update the clinical evaluation of medical devices/ performance evaluation of Ivds;
- Update the summary regarding safety and clinical performance(s) according to article 32 of Mdr and article 29 of Ivdr;
- Identify needs for preventive, corrective and remedial security actions;
- Identify opportunities to improve the usability, performance, and safety of the device;
- Where appropriate, contribute to the Pms of other devices; and
- identify and report trends pursuant to Article 88 of Mdr. e Article 83 of Ivdr.
How Pms is structured
The Pms system is based on a postmarketing surveillance plan (Pmsp) which describes the activities to be carried out, timelines for implementation, and evaluation criteria, and which includes planning for postmarketing clinical follow-up (Pmcfp) with the indication of the procedures methods for collecting performance data (Articles 84 Mdr and 79 Ivdr).
According to the established Pmsp, manufacturers of Class I medical devices must prepare a post-market surveillance report (Pmsr), which must include a summary of data collected as part of post-market surveillance, as well as an assessment of potential risks and corrective and preventive actions taken.
Instead, manufacturers of Class IIa, IIb and III medical devices are required to prepare a periodic safety update report (Psur), updated at least once every two years for Class IIa devices and at least once a year for Class IIb and III devices.
In detail li Psur, as per Article 86 Mdr, must indicate:
- The conclusions to be used in the risk-benefit assessment;
- the main results of the Pmcf; and
- the sales volume of the device and an estimate of the size and other characteristics of the population using the device and, if possible, the frequency of device use.
With regard to in vitro diagnostic devices, no particular differences are apparent: the Pmsr is prepared for class A and B devices according to Article 80 (Ivdr), updated when necessary and made available to the competent authority upon request; the Psurinstead must be drawn up for class C and D devices and updated annually as required Article 81 (Ivdr).
The Eudamed database
The data collected under the Pms are to be entered into the banca database European Eudamed according to Article 92 (MoR) e Article 87 (Ivdr).
Eudamed is an electronic platform that enables competent authorities and other stakeholders to access and process data on the safety and performance of medical devices and in vitro diagnostic devices placed on the EU market.
It is important to note that the module related to post-market surveillance is still under development and will be released when Eudamed is declared fully functional.
Pms data sources.
It is important to consider that post-marketing surveillance should not be understood solely as passive collection of device-related information on the market (e.g., collection of complaints, serious and nonserious incident reports, etc.), but rather consists of the combination of reactive activities and proactive and systematic collection, recording, and analysis of data on the quality, performance, and safety of a device throughout its life cycle.
Specifically, the proactive data collection methods outlined in the standard “ISO/TR 20416:2020 Medical devices – Post-market surveillance for manufacturers” include:
- written or electronic questionnaires
- interviews with users
- literature search
- use of registers
- Pmcf studies
- information released by regulatory agencies
In this context, questionnaires are an effective tool because they allow a wide range of clinical data to be collected from a large number of patients/users relatively easily, quickly, and inexpensively compared with other methods (e.g., post-marketing clinical surveys). They also have the advantage of being fully customizable based on device type and to meet the sponsor’s specific needs.
However, it is important to use questionnaires appropriately to ensure the quality and reliability of the data collected. To this end, the Iso/Tr 20416:2020 standard provides guidelines, specifying in particular that questionnaires should be:
- designed to be understandable and easy to fill out,
- validated to ensure accurate measurement of desired aspects and
- distributed to a representative sample of the target population.
The impact of Pms data on the clinical evaluation of medical devices
The new regulations have also raised the level of regulatory requirements regarding the collection of clinical data and evidence. In fact, they place special emphasis on the clinical evaluation/performance assessment process for the purpose of confirming compliance with general safety and performance requirements (Gspr), including the incorporation of postmarket surveillance data into the clinical evaluation/performance assessment process.
Specifically, in Mdr, clinically relevant information resulting from post-marketing surveillance, especially post-marketing clinical follow-up falls under the definition of “clinical data” provided in Article 2 and can therefore be used to update any relevant part of the technical documentation, such as those related to risk assessment, benefit-risk determination, and clinical evaluation.
In addition, MDCG Guideline 2020-6 – ‘Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC – A guide for manufacturers and notified bodies’ provides a harmonized approach with respect to clinical data that provide sufficient clinical evidence for demonstration of compliance with applicable GSPRs for medical devices previously CE marked (legacy devices) and that need to be recertified under Mdr.
Specifically, the guideline states that relevant clinical data from Pms, and particularly those from Pmcf, can be incorporated into the clinical evaluation process. Thus, the clinical evaluation plan should include a strategy and methodology to systematically collect, summarize, and evaluate data on Pms, which can be used to demonstrate continued safety and performance and support the acceptability of the risk-benefit ratio of the device.
Conclusions
The Pms requirements instituted by Mdr and Ivdr represent a significant change from previous regulations. The new requirements are more stringent and require manufacturers in collaboration with other economic operators to proactively collect and analyze a wide range of data on the safety and performance of their devices.
The goal of these new requirements is to ensure that medical devices and in vitro diagnostic devices placed on the EU market continue to be safe and effective for patients and users throughout their life cycle.
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