Market surveillance is the activity carried out by the competent authorities according to Article 93 of MDR 2017/745 to ensure that products on the market comply with the relevant laws and regulations and with the current EU health and safety requirements. Maintaining market security in Europe and promoting consumer safety and business trust is vital.
Suppose the medical device poses an unacceptable risk to the health or safety of the patients, users, or other people or any other aspects of the protection of public health. In that case, the competent authorities shall immediately require the manufacturer of the medical devices concerned, its authorized representative (AR), and all other relevant economic operators to take appropriate and duly justified corrective actions to bring the device into compliance with the MDR Regulation or withdraw or recall the medical device from the market.
Depending on the severity of the incident, the regulatory authorities require reports of serious adverse events or accidents to be submitted within 48 hours to 15 days. The most crucial aspect of market surveillance efforts is the evaluation and examination of the adverse event or incidence investigation reports, risk management reports, and vigilance data from medical device manufacturers and consumers.
If they disagree with the national legislation notified, they must immediately communicate their complaints to the European Commission and the other Member States via the electronic system referred to in Article 100 of MDR. Any measures taken by a Member State that has not been objected to by either a Member State or the Commission within two months of receiving the notification are justified.
If necessary, the authority may start a public field safety corrective action (FSCA). For significant product non-conformities, the responsible authority must evaluate if further regulatory action is necessary, which can be taken by destroying hazardous or non-compliant products, confiscating medical equipment, or assisting the manufacturer in bringing the product back into compliance with the law.
Obligations of the competent authorities are
- Monitoring devices and incidents that occur while using them
- Analyzing market data and identifying the possible potential issues
- Reviewing technical documentation
- Identifying unsafe or non-compliant medical devices
- Reactively or proactively inspecting economic operator facilities
- Removing unsafe devices from the market
The competent authorities shall develop annual surveillance activity plans and allocate adequate materials and qualified human resources to carry out those activities above. Also, they shall prepare a summary of the surveillance activities performed with the required corrective action to be set out by the economic operators and make them available on the electronic system.
The Member States will review and evaluate the effectiveness of their market surveillance efforts, which are carried out at least every four years, and be informed to the Commission and other Member States of their outcomes. Each Member State must summarise the results available to the public via the electronic system, as mentioned in Article 100 of MDR 2017/745.
The electronic system EUDAMED shall collate and process the following information on market surveillance.
- Surveillance activity results
- Final inspection report
- Unacceptable risks associated with the medical devices
- Non- compliance product information
- Results of reviews and assessments carried out by the Member states on market surveillance.
To ensure a high-quality and uniform level of market surveillance across all Member States, the competent authorities must coordinate their market surveillance efforts through joint market surveillance activities, work together, and share their results with one another and the Commission.
What is the difference between Post-market Surveillance (PMS) and Market Surveillance?
Market surveillance is the same as post-market monitoring, where they make sure that medical devices sold on the EU market are safe, effective, and compliant. Market monitoring is conducted by the appropriate competent authorities, whereas the manufacturer of the medical devices carries out PMS.
What is the role of vigilance in market surveillance activities?
Vigilance focuses on reporting serious adverse events or accidents and field safety corrective actions (FSCA). In contrast, market surveillance is entirely concerned with developing procedures that can ensure the compliance of medical devices.
Any serious incident involving a device marketed and sold in the European Union and any field safety remedial action carried out in the EU or other markets where the device is sold should be made available in EUDAMED.
What is a joint action of market surveillance?
The Joint Action on Market Surveillance of Medical Devices (JAMS) is created to strengthen market surveillance across European member states. The medical device industry carries out best practices, education, information, and resources to improve public health protection. Critical goals include enhancing coordination and assisting member states with limited resources in building their capacities and skills in the market surveillance network. It will facilitate the creation of clinical processes, equivalent resources, and a consistent and balanced approach to manufacturer inspections.