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Monitoring and surveillance in the marketing of medical devices

Market surveillance and control are a fundamental part of the marketing of both medical devices and cosmetics, sectors in continuous innovation and of great importance in the European and Spanish market.

Medical devices are an essential sector for the provision of healthcare and therefore require a high level of health protection for patients and users. This, together with the rapid evolution of the sector, mainly due to technological advances, led to the creation of a new regulation that would focus on this evolution and on the control of both economic agents and product safety. Also contributing to the development of this new regulation were the well-known cases of recalls of implants such as the Poly Implant Prothèse (PIP) breast implants, which were made with a type of industrial silicone that did not meet health standards and in 2009 began to report an abnormal increase in ruptures that alerted to these quality deficiencies.

This type of case highlights the importance of reporting any incidents and adverse effects related to products, both by economic agents and by patients and users, and of analyzing the information gathered to detect possible risks that were not contemplated during development, or any change in the frequency or severity of incidents that affect the product's benefit-risk balance.

The establishment of an adequate Post-Marketing Follow-Up system ensures that the manufactured products remain compliant with the requirements and that the experience gained from their use leads to improvements in the design and manufacturing process, as well as in the reduction of risks and the prevention of incidents related to them. Regulation 2017/745 includes this system and establishes that it must be an active process and proportional to the risk class of the product.

This information must be complemented with searches in databases or specialized literature and compiled in reports that will be part of the product's technical documentation and must be updated periodically throughout the product's life cycle. These reports should include the conclusions obtained on the benefit-risk balance, the results of the post-marketing clinical follow-up evaluation report, the sales volume of the product, the size and characteristics of the population and, if possible, the frequency of use.

Regarding Post-Market Clinical Follow-up, although this concept already existed, Regulation 2017/745 also includes it among the obligations of manufacturers. These must establish and develop a plan to proactively collect and evaluate clinical data derived from the use of the products. The data must be analyzed and documented in a post-market clinical follow-up report (PMCF) that will be part of the device's technical documentation and evaluated by the notified body. The manufacturer should also evaluate their potential impact on the other product documents, such as the risk analysis, the clinical evaluation and the summary of safety and clinical performance.

On the other hand, medical device vigilance, which involves the reporting of incidents, makes it possible to identify any problems and, if necessary, to take the necessary measures to ensure health protection, which may ultimately lead to the withdrawal of the product from the market. It is the obligation of manufacturers to collect, review and evaluate all incidents related to their products of which they are aware.

It should be noted that on January 1, 2020, the new MIR (Manufacturer Incident Report) form for reporting incidents came into force and its application will be mandatory in January 2021. The most important change found in this form is the incorporation of the IMDRF nomenclature, a system of terms and codes that internationally unifies the terminology to describe serious incidents and is divided into 7 categories: Medical Device, Problem, Cause Investigation, Health Effects and Component.

It should not be forgotten that Regulation 2017/745 establishes that manufacturers must inform the competent authorities when they detect an increase in the frequency or severity of non-serious incidents or incidents consisting of undesirable side effects foreseen and collected in the technical documentation that have produced or may generate unacceptable risks compared to the benefits of the product. To this end, they should determine in the post-marketing monitoring plan the methodology to be used to detect any statistically significant increase in their frequency or severity.

In short, the monitoring of ADRs and adverse effects is a key process in any Pharmacovigilance department, which is why Azierta offers you a large team of expert professionals and Vigilazierta, a complete technological solution capable of monitoring drugs, medical devices and cosmetics.

On the other hand, medical device vigilance, which involves incident reporting, makes it possible to identify any problems and, if necessary, to take the necessary measures to ensure health protection, which may ultimately lead to withdrawal of the product from the market. It is the obligation of manufacturers to collect, review and evaluate all incidents related to their products of which they are aware.

It should be noted that on January 1, 2020, the new MIR (Manufacturer Incident Report) form for reporting incidents came into force and its application will be mandatory in January 2021. The most important change found in this form is the incorporation of the IMDRF nomenclature, a system of terms and codes that internationally unifies the terminology to describe serious incidents and is divided into 7 categories: Medical Device, Problem, Cause Investigation, Health Effects and Component.

It should not be forgotten that Regulation 2017/745 establishes that manufacturers must inform the competent authorities when they detect an increase in the frequency or severity of non-serious incidents or incidents consisting of undesirable side effects foreseen and collected in the technical documentation that have produced or may generate unacceptable risks compared to the benefits of the product. To this end, they should determine in the post-marketing monitoring plan the methodology to be used to detect any statistically significant increase in their frequency or severity.

In short, the monitoring of AMR and adverse effects is a key process in any Pharmacovigilance department. For this reason, Azierta offers you a large team of expert professionals and Vigilazierta, a complete technological solution capable of monitoring drugs, medical devices and cosmetics.

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