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How post-market surveillance changed from the Directive to the Regulation

Although already present in Directive 93/42/EEC on medical devices (DM), the concept of post-market surveillance (surveillance, ed.) is considered one of the most critical aspects of Regulation (EU) 745/2017 (MDR). What has changed in the switch from one norm to the other is the strictness with which the requirements regarding this aspect are expressed.

The Directive, in fact, considered surveillance as an implicit obligation; the manufacturer was therefore left a wider margin of freedom: in order to comply with such obligation they were free to move in a wider area respecting the loose borders imposed by the directive. This area was narrowed in the regulation, and borders became neat: manufacturers must strictly comply with them to be conformant to prescriptions.

Actually, as early as in the having regard list, the MDR makes clear that post-market surveillance is determining in the landscape of the new medical regulations and its definition is provided for the first time under article 2.

On the other hand, article 10 lists the obligations of a manufacturer. These include the one stressed in section 9: manufacturers of devices shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance in the most effective manner and in a manner that is proportionate to the risk class and the type of device.

The quality management system concerns several aspects, and in particular the setting-up, implementation and maintenance of a post-market surveillance system, for each device.
This aspect is important because surveillance becomes explicitly and mandatorily an integral part of the quality management system and the relevant documentation is part of the technical documentation.

Moreover, articles 83-84-85-86 of the Regulation as well as Annex II are entirely dedicated to post-market surveillance. No guideline and/or document has been published so far in order to follow a common path on ‘how’ to implement surveillance and anything coming from it. However, the MDR, differently from the Directive, is richer in details and explanations allowing manufacturers or any of their delegated subjects (as in the case when such operations are outsourced) to set up a post-market surveillance that is proportionate to the risk class and the type of device.

The implementation of this system serves different purposes: updating the benefit and risk assessment and the clinical evaluation; improving the risk management; updating any information on design and manufacturing, use instructions, and labelling; updating the summary regarding the safety, and clinical performance (implantable MDs and class III devices); identifying any need of preventive, corrective, and safety corrective actions; improving the device usability, performance, and safety; identifying and reporting any trend and, if required, helping in the post-market surveillance of other devices.

The confirmation of the integration of post-market surveillance system with the quality system is the fact that the managing of both systems follows the Deming cycle (Plan-Do-Check-Act). The surveillance system is made of a plan (PMS plan), whose requirements are defined in Annex III as well as of a report, called post-market surveillance report for class I MDs or periodic safety update report for class IIa, IIb and III MDs.

The PMS plan regards the collection and use of available information allowing to investigate the experience that the device acquires on the market: manufacturers shall implement processes and procedures, methods and tools that allow them to collect data regarding proactive surveillance (safety warning monitoring, databases, and/or pertinent registries, scientific literature evaluation…) and reactive surveillance (such as data from incidents, corrective actions, complaints…)

The post-market surveillance report and the periodic safety update report summarise the results and conclusions of the collected data analysis within the surveillance based on the PMS along with a justification and a description of any preventive and corrective actions taken.
All this shows that surveillance is not an isolated system, but a complex, transversal system entwined with everything allowing the assessment of the safety and efficacy profile of medical devices.

Written by: Ilaria Perretti