Manufacturers of medical devices must monitor their products on the market. The European Medical Device Regulation (EU) 2017/745 (MDR) requires manufacturers to systematically and actively collect information on product use after a product has been placed on the European market. Based on this, the manufacturers must keep the technical documentation of their products up-to-date and cooperate with the national authorities responsible for vigilance and market surveillance. The aim is to increase the safety and performance of medical products.
- What are post-market surveillance and vigilance?
- What is Post-Market Clinical Follow-Up?
- What is market surveillance?
- What obligations does the manufacturer have?
- How does a manufacturer implement a PMS process?
- What do manufacturers have to consider about vigilance?
- What is the connection to quality management?
- What obligations does a manufacturer have during post-market clinical follow-up?
What are post-market surveillance and vigilance?
Post-Market Surveillance (PMS) is the monitoring of a medical device by the manufacturer after it has been placed on the market. To do this, he actively and systematically collects information on product use in the market. In this way, the manufacturer determines whether corrective or preventive measures are required and, if necessary, informs the competent authorities or the notified body.
If the manufacturer detects a serious incident or initiates a field safety corrective action, he must report this immediately. The MDR calls this separately regulated reporting procedure vigilance.
The definitions of the terms are important in this context. According to the MDR, a serious incident leads to death, serious deterioration in health or a serious threat to public health. If the manufacturer takes a countermeasure at this point, it is a field safety corrective action.
What is Post-Market Clinical Follow-Up?
The Post-Market Clinical Follow-Up (PMCF) describes the clinical follow-up of a medical device after it has been placed on the market. It is a continuous process that keeps the mandatory clinical evaluation of the product up-to-date. The post-market clinical follow-up is part of the post-market surveillance and is described separately in the MDR in Annex XIV.
What is market surveillance?
Market surveillance is carried out by the competent authorities. These must check whether products on the market comply with the requirements of the MDR and do not pose a risk. To this end, the responsible authorities can check medical devices using random samples. In an extreme case, the authorities can arrange for a product to be withdrawn from the market. Details are regulated in the respective national laws.
What obligations does the manufacturer have?
Manufacturers need to set up a PMS process as part of their quality management system. This must be appropriate to the risk class and type of product and ensure that data on the quality, performance and safety of a product are actively collected and analyzed over the entire product lifecycle.
The manufacturer must use the collected data to
- update the risk management and benefit-risk determination of the product,
- update the product manufacturing, instructions for use and labeling,
- update the clinical evaluation (PMCF),
- update the summary of safety and clinical performance,
- determine the need for preventive or corrective measures and, if necessary, initiate them,
- inform the competent authorities or the notified body if necessary,
- identify any serious incidents, initiate and report field safety corrective actions,
- identify how the usability, performance and safety of the product can be improved,
- recognize and report trends,
- update the technical documentation.
How does a manufacturer implement a PMS process?
The basis for this is a PMS plan prepared by the manufacturer. The MDR contains comparatively detailed information about what must be included in the PMS plan. In particular, the manufacturer must obtain the following information:
- information about serious incidents,
- information about field safety corrective actions,
- records of incidents,
- data on side effects,
- trend reports,
- information from specialist literature, databases or registers,
- information from users, distributors and importers including feedback and complaints and
- information about similar medical devices (where publicly available).
The PMS plan must describe the methods and processes with which the PMS data obtained is evaluated. This includes the comparison between the own product and similar products on the market. The manufacturer should qualify at least the following aspects in the PMS plan:
- indicators and thresholds for risk management and the determination of risk-benefit,
- methods for examining product-related complaints and experiences,
- procedure for trend reports with a view to occurrence, severity and period,
- manner of communication with all stakeholders involved,
- clinical follow-up plan (PMCF) or a reason why it is not applicable.
Manufacturers of class I products prepare a PMS report. This contains a summary of all results with corresponding conclusions. The report will be updated as necessary and made available to the competent authority on request.
Manufacturers of products in risk classes IIa, IIb and III have more extensive reporting obligations. This includes a safety report (Periodic Safety Update Report, PSUR) that needs to be updated regularly. In addition to the summary with all results and conclusions, the safety report also contains a justification and description of any preventive and corrective measures taken.
Manufacturers of products of risk classes IIa, IIb and III must include the following aspects in the safety report during the entire service life of the product:
- the result of the risk-benefit evaluation,
- the main results of the clinical evaluation report,
- the total sales volume of the product,
- an estimate of the number of people who will use the product and
- an estimate of the frequency of product use.
The safety report is part of the technical documentation. The manufacturers of class IIa products update the safety report as necessary, but at least every two years. The manufacturers of products of classes IIb and III update the safety report at least once a year.
Essentially, manufacturers submit the safety report to their notified body and – upon request – to the competent authorities. In deviation from this, manufacturers of class III products or implantable products submit their safety reports to the notified body via EUDAMED. The notified body then makes the safety report available to the responsible authorities via EUDAMED after the inspection.
In addition, manufacturers of implantable products and class III products are also required to use PMS data for the summary of safety and clinical performance according to article 32 MDR.
What do manufacturers have to consider about vigilance?
Manufacturers must report serious incidents to the responsible authorities via EUDAMED and, if necessary, initiate field safety corrective actions. The reporting deadline depends on the severity of the incident.
Usually, reports must be made immediately. However, the MDR gives manufacturers a period of 15 days. This period is shortened to 10 days in the event of death or unforeseen serious deterioration in health. If there is a serious risk to public health, the period is reduced to 2 days. Field safety corrective action also require reporting before they are taken.
The MEDDEV 2.12-1 guideline contains additional requirements for the vigilance of medical devices. It describes the roles of the actors, the connection to national laws or the content to be reported. In 2019, the EU published a supplement to MEDDEV 2.12-1, which mainly contains updates with a view to the current requirements of the MDR.
What is the connection to quality management?
Medical device manufacturers must have a quality management system. The harmonized standard ISO 13485 describes the requirements for it. The MDR stipulates that post-market surveillance must be an integral part of the quality management system.
ISO 13485, for example, requires systematic monitoring of a product after its launch. Chapter 8 of the standard presents the requirements for a continuous feedback process of information. The information obtained is incorporated into the mandatory risk management.
With a view to the market phase, ISO 14971 does not focus on the manufacturer’s reporting obligations. The requirements of the standard, on the other hand, ensure that PMS data are obtained and used for the continuous evaluation of the risk-benefit ratio of the product concerned.
What obligations does a manufacturer have during post-market clinical follow-up?
During the clinical follow-up, the manufacturer collects and evaluates clinical data for the product on the market. The product must have a CE mark and be used for the intended purpose. The goals of the PMCF are:
- confirmation of the safety and performance of the product during its lifetime,
- determination of side effects and contraindications,
- identification of risks and
- ensuring an appropriate risk-benefit ratio for the product.
The manufacturer must also use the PMCF to determine whether its product may be systematically incorrect, i.e., it is used incorrectly or beyond the approval. The manufacturer uses this to check whether the intended purpose has been appropriately selected.
The manufacturer must formulate a PMCF plan. This includes at least:
- a description of the specific PMCF objectives,
- a presentation and justification of the methods, e.g. to obtain clinical experience or user feedback, to analyze scientific specialist literature or to screen other sources of clinical data like registers or clinical studies,
- the relation to clinical evaluation and risk management,
- a procedure how clinical data on equivalent or similar products are obtained and evaluated,
- references to all relevant common specifications, harmonized standards and guidelines as well as
- a schedule.
The PMCF results are part of both the PMS report and the safety report (PSUR) and are also part of the clinical assessment report.
The MDR significantly increases the requirements for medical device manufacturers in terms of market observation and monitoring. Another requirement arises from the person responsible for regulatory compliance to be named in accordance with Article 15 MDR who is also responsible for ensuring that all obligations arising from the monitoring of medical devices after they have been placed on the market are implemented. This includes all vigilance reporting requirements.
Since all requirements for post-market surveillance, vigilance and market surveillance are mandatory from May 26, 2021, all manufacturers should already have implemented corresponding processes despite the current changes in transitional regulations and the introduction of EUDAMED.